text:
The Rapid Alert System for Non-Food Products (RAPEX)
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Report 44 (Published on: 04/11/2011)
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1 1206/11
Category: Motor vehicles
Product: Passenger car 207
Brand: Peugeot
Type/number of model:
Type Approval No.: e2*2001/116*0340*16; e2*2001/116*0340*17; e2*2001/116*0340*20; e2*2001/116*0340*21; e2*2001/116*0340*22; e2*2001/116*0340*23; e2*2001/116*0340*24; e2*2007/46*0072*02
Chassis No.: VF3 WA9HPO 9E093998 to VF3 WC5FS2 CW000483
Manufacturing period: 20/01/2011 to 23/05/2011
Batch number/Barcode:
OECD Portal Category:
Description: Passenger car
Country of origin: France
No pictures are available
The battery earth cable may break at the gearbox and cause the engine to cut out.
Voluntary measures: Voluntary corrective action taken by the manufacturer
Denmark, The Netherlands, Greece, Sweden, United Kingdom, Norway, Portugal, Slovenia, Hungary, Lithuania
2 1207/11
Category: Toys
Product: Plush rattle "Hochet Bulle" 17cm (model: bright pink cat)
Brand: Gipsy
Type/number of model: Batch 80159-251110 – Gencod 3 268060 801594 (reference 080159 – batch 251110)
Description: Plush rattle: rounded base in bright pink plush material, body in fabric printed with pink, mauve, green and yellow spots on a white background, cat's head in grey plush material and white face, hat in bright pink plush material; Rattle inserted in the head.
Country of origin: China
The product poses a risk of choking because the seam can be easily opened making accessible a small ball which can be easily swallowed.
The product does not comply with the Toys Safety Directive and with the relevant European standard EN 71-1.
Compulsory measures: Withdrawal from the market and recall from consumers ordered by the authorities.
3 1208/11
United Kingdom
Category: Furniture
Product: Bucket chair
Brand: Poundstretcher
Type/number of model: Batch ID M4323103
Description: Fold up bucket chair with fabric and foam seat. Folding metal frame.
The product poses a risk of fire because, when subject to an ignition source, the cover and filling materials produce escalating combustion which requires forcible extinction.
The product does not comply with the relevant national standard BS 5852.
Voluntary measures: Voluntary withdrawal from the market.
4 1209/11
Product: Dolls
Brand: 1. Beautiful Girl2. Unknown3. Unknown4. Unknown
1 - 1001001087,
2 - 11010295,
3 - 070100655,
4 - 10030599
Batch number/Barcode: 8810031505991, 8810011510878 and 8811011502955
Description: Dolls with accessories, some with little mermaids. Description of the packaging: - a cardboard box with a label bearing the following: the importer's details, barcode, safety warning and the statement 'Made in China'.
The products pose a chemical risk because they contain respectively 0.2%, 5%, 4.8% and 0.9% by weight of bis (2-ethylhexyl) phthalate (DEHP).
According to the REACH Regulation, the phthalates DEHP, DBP and BBP are prohibited in all toys and childcare articles, while phthalates DINP, DIDP and DNOP are prohibited in toys or childcare articles that can be placed in the mouth by children.
Compulsory measures: Import rejected by the customs authorities.
5 1210/11
Category: Lighting chains
Product: Lighting chain "Cortina 160 Luces Multicolor"
Brand: Fantastiko
Type/number of model:
- ref. 93586 and 93587.
Batch number/Barcode: 8413930935878 and 8413930935861
Description: The articles are curtains of 160 lights, one multicoloured and one white. Packed in a cardboard box bearing the brand name and the words 160-light curtain, flashing sequence control and transformer. For external use. " in Spanish.
Electric shock
The product poses a risk of electric shock because:
- the bulbs do not have sufficient mechanical resistance;
- the effectiveness of the permanent connections for the terminals is not sufficient;
- the cable does not have sufficient resistance to pulling.
The product does not comply with the Low Voltage Directive (LVD) and the relevant European standard EN 60598.
6 1211/11
Category: Food-imitating products
Product: Imitation confectionery
Brand: Kurt S. Adler
Batch number/Barcode: 086131125799
Description: The samples consist of three slim rods tied together, each with an element shaped like a piece of confectionery on the end, as follows:
1. Heart sweet (half pale pink, half cream) with red tips (2.5 cm – 5.5 cm wide by 5.3 cm high)
2. Chocolate-coloured heart sweet (2.5 cm – 5.6 cm wide by 5.5 cm high)
3. Coloured cake (diameter 4.6 cm and 5.9 cm, height 5.8 cm).
Each sample bears a white cardboard label with the following text: "Holidays Are – Kurt S. Adler - since 1946 – Item # J9815 – barcode: 086131125799 – NOTICE : this is a decorative article, not a toy or intended for use by a child under 14 - Kurt S. Adler, INC. Y., NY 10001 - www.kurtadler.com Made in China."
The products pose a risk of choking because their form, appearance and colour are such that it is likely that children will confuse them with a foodstuff and consequently ingest them.
During normal handling, the "sweets", particularly the heart-shaped sweet, can break producing parts small enough to be swallowed (1.2 x 2.7 cm 1.9 x 3.2 cm).
The product does not comply the Directive 87/357/EEC concerning products which, appearing to be other than they are, endanger the health or safety of consumers.
Compulsory measures: Products seized by the authorities.
7 1212/11
Category: Electrical appliances and equipment
Product: Plug adaptor "Europa"
Brand: An Dong Yuan
Type/number of model: Ref 1119
Batch number/Barcode: 6253216811197
Description: Plug adaptor
The product poses a risk of electric shock because the sockets are not recessed and, when a plug is inserted into the adaptor, the live pins of the plug may be accessible.
The product does not comply with the relevant national standard.
8 1213/11
Brand: Ady - An Dong Yuan
Type/number of model: Ref 417 y 6068002
Batch number/Barcode: 8409660680027
Description: This is a white adapter. Description of the packaging: -The product comes in a blister pack bearing the following information: the brand, reference, barcode and the importer's details.
The product poses a risk of electric shock because it has no shutters.
The product does not comply with the relevant national standard UNE 20315.
9 1214/11
Product: Plastic dolls "New Style Beauty dolls"
Brand: Bullycan
Type/number of model: Ref. 838
Description: A 'Barbie' style doll with another smaller doll, and a range of clothing and accessories. Description of the packaging: A cardboard box with a transparent window bearing the words 'New Style Beauty', 'Princess' and 'style girl modern'.
The product poses a chemical risk because the head of the smaller doll contain more than 0.2% by weight di-(2-ethylhexyl) phthalate (DEHP) and the shoes contain over 0.2% of di-isononyl phthalate (DINP).
According to the REACH Regulation, the phthalates DEHP, DBP and BBP are prohibited in all toys and childcare articles, while phthalates DINP, DIDP and DNOP are prohibited in toys or childcare articles that can be placed in the mouth by children.
Compulsory measures: Imports rejected by the customs authorities.
10 1215/11
Product: Dolls with ponies "Joyful Castle"
Brand: Joyful
Type/number of model: Model: 6622
Description: -Doll with accessories (2 ponies and a castle). Description of the packaging: a cardboard box with a transparent window bearing: the mark and the model number.
The product poses a chemical risk because the head of the doll contains 0,178%, the yellow pony contains in excess of 0.2% and the purple pony contains 0.198% by weight of bis (2-ethylhexyl) phthalate (DEHP).
11 1217/11
Product: Play gym (zabawka gimnastyczna)
Brand: Baby Mix
Type/number of model: ITEM NO: 50301
Batch number/Barcode: 5907704010593
Description: The play gym is a plastic, multicoloured toy with 4 legs and a crossbar. Removable elements are attached to the crossbar: 2 rattles hang on the plastic tray and a sheep figurine, which makes a sound and emits a light. The play gym also has 2 plastic rings (with a diameter of 83 mm) with hanging, flat elements. On the sticker and on the packaging there are warnings and information concerning the product in Polish, the name and address of the distributor, the "CE mark", "Made in China", the number of the product, an EAN and the information that the toy requires pre-installation.
Choking, Damage to hearing
The product poses a risk of:
- injuries because it protrudes too much and does not comply with the requirements on shape and size of certain toys;
- damage to hearing due to the high sound level (86,5 ± 0,6x dB).
The product does not comply with the Toys Safety Directive and with the relevant European standard EN 71-1.
Compulsory measures: Withdrawal from the market ordered by the authorities.
12 1218/11
Category: Hobby/sports equipment
Product: Scooter MF 3.6
Brand: Oxelo
Type/number of model: 1282678 sold from 07-11-2010 to 12-02-2011
Description: Freestyle scooter not suitable for young users. Maximum user weight: 100 kg.
The product poses risk of injuries because the handlebar can crack and break.
Voluntary measures: Voluntary recall from consumers.
13 1219/11
Product: Dolls "My Baby Happy Day" twin dolls
Brand: Mistertoys
Type/number of model: Ref 077198
Batch number/Barcode: 8424906771987
Description: Twin baby dolls wearing a bonnet and pyjamas with a teddy bear's head on the front. Description of the packaging: a cardboard box bearing the brand name and "My Baby Happy Day". A sticker on the back shows the details of the importer, the CE mark, the reference number, the barcode, the warning that the item is not suitable for children under the age of 3, instructions on how to change the batteries and "Made in China".
The product poses a chemical risk because the hands and the feet of the dolls contain more than 0.2% by weight di-(2-ethylhexyl) phthalate(DEHP).
14 1220/11
Product: Plastic caterpillar "CATERPILLAR"
Brand: Unknown
Type/number of model: NO:FW1169
Batch number/Barcode: 6933108004431
Description: Plastic caterpillar with cardboard and plastic packaging
Choking, Injuries
- choking because the head, body and shoes can easily break into small parts that can be swallowed;
- injuries and scratching because the ball can be detach from the springs and it has sharp edges.
15 1221/11
Category: Protective equipment
Product: Cycling helmet "Kerékpáros Sisak Gyermek"
Brand: D Safety
Type/number of model: MV-6-2
1) 618000015,
2) 618000016
Description: Two cycling helmets:
1) blue with stars and heads of animals,
2) rose with varicoloured flowers
Outer shell of the helmets is made from plastic, inner part of white polystyrene, black chin straps are closed with plastic locking device. The helmets are packed in transparent plastic bags.
The straps of the helmets are not strong enough and could break in case of an impact.
The products do not comply with the Personal Protective Equipment Directive and the relevant European standard EN 1078.
Compulsory measures: Sales ban ordered by the authorities.
16 1222/11
Product: Night light "Automatic Night Light"
Brand: Home Essentials
Batch number/Barcode: 5050577 584637.
Product Code: O-58463.
Description: Nightlight mounted on a 3 pin plug. Includes a spare bulb.
The product poses a risk of electric shock because it does not incorporate a suitable fuse to provide overcurrent protection.
17 1223/11
Category: Other
Product: Smoke alarm "Détecteur de Fumée Sans Fil Autonome"
Brand: IDK
DET 010/KD-107 The products concerned were manufactured on 19 April 2011
Batch number/Barcode: 3 539 290 007651
Description: Smoke alarm.
The failure to detect commonly occurring types of fire and the insufficient sound power do not permit the user and others around them to take the measures necessary to avoid the risk of fire.
The product does not comply with the Construction Products Directive and the relevant European standard EN 14604.
Voluntary measures: Voluntary withdrawal from the market and recall from consumers.
Products seized by the authorities.
18 1224/11
Product: Plastic Dolls
1. Sikaly
2. Pretty Barbie (THIS PRODUCT MAY BE COUNTERFEIT)
3. Magical Girl
Brand: Mistertoys
1. 77208
2. 77206
3. 77210 (red) and 77211 (pink)
Batch number/Barcode:
1. 8424906772083
2. 8424906772069
3. 8424906772106 (red) and 8424906772113 (pink)
Description: Dolls, some dressed for sport and others in party dresses. The dolls are individually packed, with a label containing the following information: the importer's details, CE mark, reference, barcode and "Made in China".
The dolls contain a concentration of DEHP of more than 0.2% by weight. The shoes of the "Sikaly" doll and the shoes of the "Pretty Barbie" doll were also found to contain a concentration of DINP of more than 0.2 % by weight.
According to the REACH Regulation, the phthalates DEHP, DBP and BBP are prohibited in all toys and childcare articles while phthalates DINP, DIDP and DNOP are prohibited in toys or childcare articles that can be placed in the mouth by children.
19 1225/11
Product: Toy boat
Brand: Sand
Type/number of model:
Batch number/Barcode: 8422156296700 and 8422156296717
Description: Toy boat with a rake, spade, etc. The toys are packed in a plastic net bag and carry a label marked with the importer's details, the CE mark, the barcode and the statement "Made in China".
The product poses a risk of choking because it includes small parts (a flag and a washer) that fit completely into the small parts cylinder and which can be easily swallowed.
The product does not comply with the Toys Safety Directive and the relevant European standard EN 71-1.
20 1226/11
Product: Electric radiator
Brand: Matsui
Type/number of model: M15ORW09
Description: Small electric oil filled radiator.
The product poses a risk of fire because the thermostat may become faulty and therefore not stop the product overheating.
One incident of fire reported.
21 1227/11
Czech Republic
Category: Childcare articles and children's equipment
Product: Baby walker
Brand: Pikolo
Type/number of model: SB-805A EAN 3853920080518
Description: The walker is intended for children of 5 to 14 months, maximum weight capacity is 12 kg. The basic frame is made from steel tubes, cross joined by rivets and plastic toggles. The upper frame is plastic and fixed to the lower part by screws. The textile seat is removable; the seat is adjustable in height to 4 positions. The wheel frame has 6 plastic wheels, 50 mm in diameter. The weight of the baby walker is 2.1 kg.
The product poses a risk of injuries because stability is not sufficient and it can tip over or fall downstairs. In addition, the height of the seat is inadequate and the folding mechanism is improper.
The product does not comply with the relevant European standard EN 1273.
Compulsory measures: Withdrawal from the market and recall from consumers ordered by the competent authority.
22 1228/11
Category: Clothing, textiles and fashion items
Product: Girls' bikini
Brand: UNION-STAR
Type/number of model: TH5090
Description: Red and black bikini for girls, with a butterfly pattern and the inscription "dollgirls little princess". The top can be tied with cords that have free ends in the neck area and at the back. The cords on the back have knotted ends. Size: 140-164
Country of origin: Unknown
Strangulation, Injuries
The product poses a serious risk of strangulation and injuries because of the presence of functional cords in the neck area and cords with knots at the back of the bikini top.
The product does not comply with the safety requirements of the relevant European standard EN 14682.
Compulsory measures: Withdrawal from the market ordered by the competent authority.
23 1229/11
Product: Safety barrier Rudolf gyermekvéd rács ("Rudolf child-protecting bars")
Brand: JÉWÉ
Type/number of model: 49207
Batch number/Barcode: 8711283066806
Description: A wooden safety barrier consisting of two parts. The width is adjustable; height: 800 mm. Packaging: cardboard box.
Country of origin: Romania
Injuries, Strangulation
The product poses a risk of injuries because of the possibility of entrapment of limbs and fingers due to an insufficient distance between the adjacent parts of the safety barrier, and because there are 7.9 mm wide and more than 10 mm deep mounting holes and gaps available.
In addition, the product poses a risk of strangulation.
The product does not meet the safety requirements of the relevant European standard EN 1930.
24 1230/11
Product: Brake pads
Brand: Auto SFEC
Number of model: BP 000429;
Batch number/Barcode: 4702170004296
Description: Set of 4 brake pads in a cardboard box.
The brake linings have Chrysotile asbestos filaments which can be extracted from the matrix mechanically. The product thus poses a risk to the health of consumer if they inhale the filaments.
The product does not comply with Regulation No 90 of the Economic Commission for Europe of the United Nations (UN/ECE).
25 1231/11
Product: Music instruments "MUSIC WORLD"
Type/number of model: Art. 0905M147, NO.899C
Batch number/Barcode: 6909051301477
Description: Cardboard and plastic packaging.
- injuries because the drum cord is too thin;
- choking because small parts can be easily detached and swallowed.
26 1232/11
Category: Jewellery
Product: Amber baby necklace "Amber necklace"
Brand: Ambergift
Type/number of model: Unknown
Description: Fancy necklace for young children made of orange, yellow and brown beads. Screw clasp. Length: 29 cm.
Country of origin: Lithuania
The product poses a risk of strangulation should it catch on an immovable object while being worn by a baby.
Voluntary measures: Voluntary withdrawal from the market by the distributor.
27 1233/11
Product: Amber baby necklace "Porte Bonheur"
Description: Amber bead necklace for babies: the beads are the same colour and shape (round and brown). Knot between each bead. Screw clasp. Length: 33-35 cm.
Choking, Strangulation
- choking, because the necklace can easily break releasing four beads which fit inside the small parts cylinder,
- strangulation, because the necklace can be caught on an immovable object.
Voluntary measures: Voluntary withdrawal from the market and recall from consumers by the importer.
Enforcement is a top priority of the EU Consumer Policy Strategy 2007-2013. Both measures leading to RAPEX notifications and measures which come to the attention of the Commission and other Member States as reactionsare indications of enforcement activity in the Member State concerned.
In order to give a better view on the overall level of enforcement, including the follow-up activities of the national market surveillance authorities, the Commission RAPEX team has decided to publish on the RAPEX website also the names of the countries that have found the notified product on their market and have taken appropriate measures (and have submitted a reaction to a RAPEX notification as a consequence).
Information about the reacting countries is available in the RAPEX weekly overviews in the column 'Products were found and measures were taken also in'. The Commission RAPEX team will publish reactions sent (from May2009 onwards) to 2009 RAPEX notifications.
DISCLAIMER: If not specified in the report, the risk and non-compliance refer to a risk for consumer health and safety
IMPORTANT NOTE: Please be aware that proprietary brands, designs and logos that appear in this listing may have been used in violation of intellectual property rights and thus without the legitimate owner's knowledge and/or permission.
The official contact points of the Member and EFTA-EEA States provide the information published in these weekly overviews.
Under the terms of Annex II.10 to the General Product Safety Directive (2001/95/EC) responsibility for the information provided lies with the notifying party. The Commission does not take any responsibility for the accuracy of the information provided.
Die in dieser wöchentlichen Übersicht veröffentlichten Informationen wurden von den offiziellen Kontaktstellen
der EU- und EFTA-EWR-Mitgliedstaaten mitgeteilt. Gem äß Anhang II Ziffer 10 der Richtlinie über allgemeine
Produktsicherheit (2001/95/EG) ist der meldende Mitgliedstaat für die mitgeteilten Informationen verantwortlich.
Die Kommission übernimmt keine Verantwortung für die Korrektheit der bereitgestellten Informationen.
Les informations publiées dans les rapports hebdomadaires sont fournies par les points de contact officiels des
États membres de l'UE et de l'AELE/EEE. Au titre de l'annexe II.10 de la directive relative à la sécurité générale
des produits(2001/95/CE), la responsabilité des informations fournies incombe à la seule partie notifiante. La
Commission décline toute responsabilité quant à l'exactitude des informations fournies.
Links to the RAPEX website may be created subject to respect of the conditions set out at the following web address:
Downloading and reproduction for non-commercial or commercial redissemination of any textual and photographic material contained in the RAPEX notifications are subject to prior permission.
The information contained in the weekly overviews may not be adapted or modified by the user. Translations of the RAPEX notifications from the original English-language edition published on the RAPEX website are subject to the conclusion of a free of charge licence agreement.
For permissions or licences, requests shall be addressed to: firstname.lastname@example.com
Links auf die RAPEX-Webseiten sind vorbehaltlich der Beachtung der Bedingungen zulässig, die Sie unter folgender Adresse finden:
Das Herunterladen und die Vervielfältigung zum Zwecke der nicht kommerziellen oder kommerziellen
Weiterverbreitung von Texten und Fotos in den RAPEX-Meldungen unterliegen der vorherigen
Die Informationen in den Wochenübersichten dürfen nicht angepasst oder verändert werden.
Übersetzungen der RAPEX-Meldungen aus der ursprünglich veröffentlichten englischsprachigen
Fassung sind nach Abschluss einer gebührenfreien Lizenzvereinbarung zulässig.
Anträge auf Genehmigungen oder Lizenzen sind zu richten an: firstname.lastname@example.com
Il est possible de créer des hyperliens vers le site web consacré au système RAPEX, à condition de
respecter les conditions décrites à l'adresse suivante:
Le téléchargement et la reproduction à des fins de rediffusion, commerciale ou non, de tout contenu
textuel ou photographique dans les notifications RAPEX doivent faire l'objet d'une autorisation
Les informations présentées dans l'aperçu hebdomadaire ne peuvent être adaptées ou modifiées par
l'utilisateur. La traduction, à partir de la version originale en anglais, des notifications RAPEX publiées
sur le site RAPEX est soumise à un accord de licence à titre gratuit.
Pour demander une autorisation ou un accord de licence, veuillez vous adresser à: firstname.lastname@example.com
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text:
Full Disclosure
mailing list archives
Michal Zalewski wrote:
I have no data on whether any of the vendors bothered to run my scripts to
find any further problems that are bound to surface.
Yes, thank you. Mozilla testers have found additional crashing testcases and
we will add the tool to our regular testing cycle.
-Dan Veditz
Full-Disclosure - We believe in it.
Charter: http://lists.netsys.com/full-disclosure-charter.html
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subset: commoncrawl


text:
The Good Room
How Ireland ended up in a debtors prison ? and how it can get out
Penguin Ireland
Hardback : 25 Oct 2012
Ireland is deeply in debt, beholden to the IMF, the EU and the bond markets. Its economy is frozen, and years of austerity are ahead.
It didn't have to be this way - and it doesn't have to be this way. In The Good Room, David McWilliams, who wrote about the dangers of the Irish property bubble and imbalances within the eurozone at a time when other commentators were saying everything was fine, explains the bizarre economics behind Ireland's current predicament, and illuminates a radically different path for the country. He illustrates the consequences of debt and austerity for ordinary Irish people and explains why austerity can't work. And he shows that history offers numerous useful models for Irish recovery - provided we open our eyes to them.
The Pope's Children was the book that connected the dots between economics and daily life in Ireland during the boom years. The Good Room does the same for the Ireland of the bust, and is - in its call for a completely different approach - an even more urgent and necessary work.
David McWilliams is Ireland's leading popular economist, and a columnist for the Irish Independent and the Sunday Business Post. He is the author of the bestsellers The Pope's Children, The Generation Game and Follow the Money.
Product details
Format :
Size : 153 x 234mm
Pages : 256
Published : 25 Oct 2012
Publisher : Penguin Ireland
Other formats for The Good Room:
» Paperback : £8.99
» ePub eBook: eBook : £5.50
The Good Room
How Ireland ended up in a debtors prison ? and how it can get out
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To keep up-to-date, input your email address, and we will contact you on publication or when the author releases another book.
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text:
knife in my head is the taste of cindy….
- the Jesus and Mary Chain were amazing and yet, they barely moved on stage. two girls crashed the stage and cat crawled behind Jim - he accidentally stepped on one of them. security were baffled but didn't do anything because why would they…
- jim kept getting tangled up in the mic cord - dropped it twice. his reactions were very much like bernard black from blackbooks, i.e. priceless.
- jim and william bickered like two old ladies. they had to restart some songs a few times because it seemed like william was following a completely different set list with different sheet music on a different day in a different year in an alternate universe…
- i met this cool cat that saw the first jesus and mary chain show in SF. he was sixteen. "they got on stage late, mumbled some songs into the mic, never addressed us, played off key for almost 20 minutes then walked off very angry." every one in line basically nodded at his story, "sounds about right." is what i said.
- they played the glorious namesake Taste of Cindy. i can die a happy, callous but selfless, cold & self-composed bitch now *grin
- i took crappy pictures - some of which may be uploaded. two videos (just like honey & between planets for jennybeans) that need editing.
- the magic wands opened & were pretty great. and so nice, which threw me off. i expected cool, aloofed detachment. but nope. they were sweet.
a homeless man offered me a great connection to heroin, speed, meth and acid if i wanted to party after the show. i politely declined.
- spent the rest of my weekend with the little brother who thinks he's older than me (we're 4yrs apart). bickered. tried to get our mother drunk at the olive garden because we're classy.
that is all.


text:
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text:
Here, new starter Greg McElroy has his team deep in Chargers territory. We are again going to follow Braylon Edwards, again marked in green. See the Chargers' front seven, circled in blue? Notice how they are moving up on the line of scrimmage? That would indicate an all-out blitz.
Edwards and McElroy both know that Edwards is the "hot" receiver, otherwise known as the guy the QB will look for first in the face of the blitz. Braylon runs a quick out pattern, as noted in the picture with the green arrow. Does he get enough separation to give his QB somewhere to throw to? Let's move ahead and see.
The answer is no, no separation at all. There is not a lot of room for McElroy to make a throw. Had the separation been better, it would have made for an easy TD. Instead………..
McElroy has to basically throw the ball away. Not in the literal sense, but because the DB is so close, Greg has to put the pass up high wear he could thrown an incomplete pass, if his receiver doesn't touch it. He does, and the pass is incomplete.
See what I mean? There is a lot to be said about the chemistry between Mark Sanchez and Braylon Edwards. Don't get me wrong. If anyone wants to see an asset brought in to help Mark Sanchez, it's me. I think that is obvious if you read this blog at all regularly.
But the film doesn't lie. If a guy isn't getting open, he isn't getting open. If Braylon Edwards can't get separation consistently, how does that make him better than what we already have?
That is why, to me, Braylon isn't here. It is also why they don't need to bring him back either.


text:
To make reservations by phone, call 1-800-321-2211 in the USA and Canada (or any of our worldwide reservation telephone numbers).
2899 Jefferson Davis Highway
Arlington, Virginia 22202
Courtyard Arlington Crystal City/Reagan National Airport
Airport Phone: 1 703 4178000
Hotel direction: 0.5 miles W
Airport Shuttle available from 5:05 am through 11:00pm daily. Airport shuttle picks up every 20 minutes at baggage claim Doors 5 and 9 and "Hotel Shuttles" stop for Terminal A. When exiting the airport, follow the signs for Alexandria, taking US Route 1 South. Turn left at the 1st light on to 27th street, Hotel is on the right.
Airport Phone: 1 703 572 2700
Hotel direction: 30 miles E
Take airport Toll Road heading East to Route 66 East to Exit 75 (110 South) follow to Route 1 South then turn left onto 27th St. Hotel is on the right..
This hotel does not provide shuttle service.
Airport Phone: 1 410 859 7111
Hotel direction: 40 miles S
Exit Airport and take I-295 South. Exit at US-50 (NY Ave.) toward D.C. Enter Hwy 395 South and follow signs to US-1 in Crystal City. Left on 27th Street and hotel is on the right.
This hotel does not provide shuttle service.
1700 Jefferson Davis Highway
Arlington, Virginia 22202
Phone: 1-703-271-5245
1225 S Clark Street
Arlington, Virginia 22202
Phone: 1-703-418-7240
Alamo Rent A Car
23430 Autopilot Dr
Dulles, Virginia 20166
Phone: 1-888-826-6893


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Sandy Koufax Windup
Photo: Jamie Baldwin
Reproduction in the form of a digital print of a series of photographs I took of Sandy Koufax in four stages of his windup. The result was four negatives superimposed on each other to create the effect. Photos were taken in 1966 during a game at Dodger Stadium in Los Angeles.


text: ZoomInfo ZoomInfo Becky Cloonan's new cover art for the DEMO omnibus. The 2014 version of the 2003 original. To answer a common question: these will be softcovers, but high end softcovers, with thick paper, dozens of pages of extras, spot gloss covers, and so on. Very much like the Channel Zero edition Dark Horse published. Posted June 17, 2014 2856 notes


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Well, this will surely send a few tremors through Tuscaloosa, Ala., I'm guessing.
This is Nick Saban up to his old mendacious ways, and if anyone who bleeds the appropriate color for the Crimson Tide is surprised, shame on him or her. Like you didn't know this was the guy's M.O.?
This is the same man, remember, who flatly denied he was leaving the Dolphins for Alabama, and then left the Dolphins for Alabama. Now he says he's "too old" to go anywhere else but Alabama -- and his agent says, weeeellll, we might consider Texas, but only Texas.
Gotta come as a shock to those who thought Saban was saying he wouldn't consider anywhere. Anywhere clearly doesn't include Texas, which, sorry, 'Bama, is a better job simply because of the money around the program, the recruiting base, and the money around the program. And did we mention the money around the program?
So take a lesson, Tide Riders: When Nick Saban tells you the sky is blue and it ain't gonna rain, check first. And then grab your umbrella.


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GreatSchools Rating
Teacher quality
Principal leadership
Parent involvement
I have 2 children attending this school.My son has a problem with reading and his teacher is going above and beyond to help him which has made a huge difference with his reading.My daughter loves going to this school.They have both made alot of friends and their teachers are great.We really like this school.
Our 8 y.o. son's 2nd & 3rd grade teachers have exceeded our expectations in all areas - genuine care for students, calm control of class, academic focus, attention to individual needs, communication with us, & just pleasant personalities. The principal seems more serious & perhaps introverted, one time we called with a question, we were put on hold, & the principal came on line, did not seem rushed, gave attention to the subject, & was pleasant. She was at the fall festival having wet sponges thrown at her face with a smile. The school size & location is wonderful, too. Even though we were concerned about his 1st grade teacher's approach to motivating students, she taught academics well & our son learned the curriculum. From talking with other parents, views of different teachers of various grades have kept our confidence with the school.
My child has a horrible teacher and the principal is just as bad. I don't think the principal is very truthful and changes things for her benefit. There are great teachers there but we didn't receive one. The office staff is also very rude.
Just moved here from out of state. This is the first week of school for my daughter. My daughter attended a school that had a high standard of academics, better quality of teachers, and a more progressive method for instruction. I think this school is barely adequate. I am looking for a private shcool.
My son has been going to Heckethorn for over a year now. His teacher is absolutely amazing. She truly cares about each student's learning and actually tailors assignments based on educational level. She's fabulous. I have never met the principal, but I see her actively involved with the kids quite a bit. It is a truly great school with amazing, supportive teachers and involved parents. The front desk staff is very pleasant this year.
We switched from a private school to Heckethorn and loved it. The teachers are wonderful and really care and cater to each and every student. Can't say enough about how impressed I am.
The Teachers are fantastic. The psycho that works the front desk is horrendous!
The administration at this school is horrible. The first year my son attended school there I didn't even know what the principal looked like until an awards assembly at the end of the year. I never see her greeting the children in the morning or saying goodbye in the afternoon. If you have a concern she doesn't want to here it. She stands behind her staff 100% no matter what the problem may be. Most of the teachers are nice but there are definetely some bad apples. I think my son has more common sense then a few of the staff at this school. There is alot of bullying that goes on at this school and alot of staff members who like to yell.
My children have only been here for 1 month and I feel blessed that they have the teachers that they have. I have a child in 2nd and 5th. Their teachers are great and my children enjoy school. I am excited about the enrichment camps that will be provided. This is a time for the kids to experience other activities that they might not be able to any other time. There are a few things that I believe could be handled differently, but all in all my family has been happy with this school.
This school is horrible! I am not sure if it the lack of good teachers or the fact that there is no accountability at this school but it has got to be one of the WORST schools I have ever seen! One of the worst is their so call 'enrichment camps' bowling, and quiltng but no math or reading! I would rather my son excell in reading or writting or math and science than bowling!
My son attends Mrs. Nicholas Pre-school program for special needs kids. I could not have ordered a better teacher for him. She loves the kids and knows through her years of teahing how to help each child reach thier potential. She is an asset to Clark county school system.
The staff is absolutley wonderful and I feel very blessed to have my children attend such a wonderful school full of adults who truly care!
I am very proud my child attends this school. I believe it is one of the best in the Las Vegas valley. One of the few that still has a moment of silence after the pledge.
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The Community Rating is the school's average rating from its community members (e.g., parents, students, and school staff). The highest possible rating is five stars; the lowest is one star.
5150 Whispering Sands Dr
Las Vegas, NV 89131
Phone: (702) 799-6690
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The Shiromani Akali Dal (Delhi) on Thursday vowed support to the Congress in Delhi for the assembly elections slated for December 4.
The leader of the outfit, Paramjit Singh Sarna — a former president of the Delhi Sikh Gurdwara Management Committee — claimed that the Bharatiya Janata Party (BJP) has done nothing for the Sikhs.
Another faction of the Akalis led by the Badals is fighting the Delhi Assembly polls in alliance with the BJP.
Sarna said: "The BJP did nothing to get justice for the victims of the 1984 riots. The Congress has not only accepted some of the demands made by the Sikhs but also recognised the sacrifice of Guru Tegh Bahadur by building a huge memorial."
SAD (Delhi) has been traditional supporters of the Congress. Sarna had played a crucial role in bringing four-time legislator Harsharan Singh Balli to the Congress fold after he was denied ticket to recontest.
He said the BJP has fielded just one Sikh candidate for 70-member Delhi Assembly while the Congress has given tickets to six Sikhs. SAD (Delhi) and SAD (Badal) are archrivals in Delhi's gurudwara politics.
Sarna alleged that the Badal group is also misusing gurdwara committee's machinery to win the elections. "About 300 students and staff of committee's educational institutions are working round the clock for them. They are also misusing committee's vehicles, laptops and other assets. Their workers are given food prepared at the gurdwaras," Sarna alleged.
A divorce, a jail term, determined foes: Bihar CM Nitish Kumar fighting a lone battle?
The divorce between Narendra Modi's Bharatiya Janata Party and Nitish Kumar's Janata Dal(U) and a few days of change in residence for Rashtriya Janata Dal's Lalu Prasad – from 10, Circular Road in Patna to the Ranchi jail in Jharkhand – have totally changed the game that is played in Bihar.
Angry with the SP, convinced that the Congress is a losing proposition, unsure of AAP's ability to win, and fearful that Mayawati may ally with the BJP in the future, Muslims have a difficult choice.


text:
This past weekend, J and I discovered one of our new favorite wineries - Casa Nuestra. What a hidden gem. We stumbled upon it because we were looking for a low key vineyard where we could bring a picnic lunch, buy a bottle of delicious vino, and sit outside to enjoy the 75 degree temps.
Casa Nuestra came up in a list of "The Best Wine Country Picnics" in Napa Valley by SF Gate. They nailed it, calling the winery "hippie-dippy". We couldn't have asked for a more perfect spot. The family-owned, appointment-only funky farmhouse was established in historic St. Helena in 1979. The name Casa Nuestra means "our house" and was named by the vineyards predecessor, after his spanish-mexican heritage. I'm already in love with it for its name and history, but wait there's more…
Their wines are produced entirely by their organic vineyards (and let me tell you they are tasty) and all three buildings on the property are solar-powered. Like most wineries in Napa, if you buy a bottle of wine the tasting fee will be waived. Welp, we certainly didn't hesitate - we purchased a bottle of their most popular Tinto to have with lunch, and a bottle with the cutest label I've ever seen, Two Goats Red, to take home with us.
We sat outside in chairs made of wine barrels, listening to the birds chirp as we devoured our lunch and half the bottle of Tinto. This was our happy place.
And you want to know one more reason we fell in love with this quaint little spot? A goat named Elvis (named after the one and only Elvis Presley who filmed a movie on the property)!
A must visit, I know we'll be back, but let's keep this our little secret, eh?
Tasting room
J instagram-ing Elvis
Best wine label
My happy place
A few other photos worth sharing via the internet :)
Holy moly this actually works! I watched Jordan's video below and found a bunch of others. AH-mazing.
What is this madness?
No…but seriously…
this isn't possible, is it?
Wizardry! From the French!
(If you know any ways to remove wine bottle corks sans openers, please leave them in the comments for the edification of all.)
A much overdue birthday post…
Last year's birthday post has inspired me to keep up the tradition of tracking the birthday activities, venues, and eats.The past five were spent in NYC and how fun it was to look back on how things changed over the years - so this marked my first west coast birthday! The b-day fell on a Wednesday night this year so the night before my good friend Kate threw me a little girlie get together at her apt with apps and wine (we tried ReWinery, yay!), and then Wednesday night Jeremy and I dined at Nopa (which was delicious and took a month to get a reservation!) The weekend following, in typical northern California style, we rallied together Sarah and Danielle, who you remember from my recent travels and their BFs, and our good friends Jared and Carmen who you remember from many fun SF & Maine adventures and we headed up to Jeremy's parents condo in Napa (thanks Franks!) for some eating, drinking, and living room dance-partying.
Thanks to everyone for such a great birthday! Some of the fun details and snaps below.
Venues: Kate's Apt, Nopa, Weekend in Napa Valley (including Guilliams Winery, and Mumms)
Good Eats & Drinks: ReWinery, Strawberry Short-Cake & Strawberry Confetti Cake
(I'm on some weird strawberry kick this year I guess), Pinata (?!) + Flabongo, and lots of delicious wine and bubbles
Double the birthday, double the fun! Gar's (Sarah's bf) birthday was a week after mine so we thought it was the perfect excuse for us to combine forces and head away for the weekend to celebrate.
Group shot at Guilliams Winery in Spring Mountain district - highly reco this family run spot, you'll need resi, but it's totally worth the gorgeous drive up the mountain.
Pedro the Pinata
Pot de Crème a la Nopa
Apps via Lauren and Kate :)
Strawberry Short Cake
ReWinery success! How adorbs are those labels? We had to keep the bottles. The "Mission" Pinot Noir was our fav (far right).
What was in this box you ask? A tennis racket and 3 hour long tennis lessons at the CA Tennis Club!
Have you SF'ers heard of this amazing service?
Basically the next time you are desperately in need of a glass of vino and are too lazy or just can't make it to the store - Rewinery will bring you a trio of delicious high-quality wines to your home, office, or even your picnic blanket in Dolores Park - for a flat free of $40!
You can order wine daily until 2 AM within SF by phone or via their iPhone app. I mean, this sounds like a dream if ya ask me. Reminds me of the delivery ice-cream club I joined in NYC which was amazing. I will give it a try and let you know how it goes.
Thanks to Tasting Table for the note.
About a year ago a bunch of us went to Lil Frankies in NYC's east village for a nice hearty Sunday dinner. Lauren, (my current roommate!) happened to be in town visiting and we wanted to show her our idea of the perfect cozy NYC spot for wine and pizza as a way to wind down the weekend.
One thing that is AMAZING about this gem besides the food of course, is that they offer Wine by Consumption. What does this mean you ask?
As far as we know, we are the only restaurant that offers a program like this. We are willing to open any of the bottles on this list and pour you a glass. Or a half a glass. Or open the bottle and leave you alone with it until you have reached your limit, or the bottom. You let us know when you are finished and we will measure the bottle and charge you accordingly.
How great is that? This was the only restaurant I knew that offered such an amazing service until I moved out to SF and discovered Frances - another gem.
*Picture above: Sunday family dinner = Two pizzas, two pastas, two salads, two bottles of vino. Thanks Frankie. Saying we left full is an understatement.


text:
Find it here, go there on your phone.
what you want to do on Scout.me, open your Scout App, and tap the to get driving!
Placerita Canyon
This fun-filled little adventure is sure to make for a great time with family and friends. Along the way there ... localhikes.com
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Sepulveda Dam
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O' Melveny Park
Take a stroll along citrus groves, grassy fields, and a riparian canyon in this tranquil park situated in Granada H... trails.com
Most hikers, bikers and endurance runners regard Los Pinetos Peak more as an obstacle to conquer than a thing of be... trails.com
Newhall Pass: Weldon Canyon Trail
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Mission Point: Mission Point Trail
Billowing grass and seasonal wildflowers paint a pastoral landscape on the slopes of L.A.'s second-largest city par... trails.com
Two Placerita Canyon trails offer pleasant excursions into the park's backcountry. Waterfall Trail ascends along Lo... trails.com
Thirteen-mile long Verdugo Fire Road, sometimes called Backbone Road, travels almost the whole length of the Verdug... trails.com
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text: The Political Scene October 21, 1996 Issue MY RIGHT-WING CONSPIRACY By William F. Buckley View Issue» MY RIGHT-WING CONSPIRACY The New Yorker, October 21, 1996 P. 120 ABSTRACT: THE POLITICAL SCENE about the meetings of the conservative John P. Gaty Trust in Wichita, Kansas from 1967 to 1977. In 1964, Barry Goldwater was beaten in the Presidential races by Lyndon Johnson. At that time, conservative thought was unwelcome in the American political arena. But, 16 years later, Ronald Reagan was swept into office on a platform indistinguishable from what Barry had been preaching. What happened? My own explanation is John P. Gaty. I first saw his name in 1967 on a letter from the senior vice-president and trust officer of the Fourth National Bank and Trust Company of Wichita, Kansas, which advised me that I had been named one of 9 trustees who were given the responsibility of disposing of the residual estate of the late John P. Gaty Gaty was the vice-president and general manager of the Beech Aviation Company, in Wichita. He specifically wanted the money from his estate to go to conservative causes. The trustees would meet annually in Wichita, and could each distribute $10,000 to the recipients of their choice, as well as cast a vote on how to allocate the rest of the year's portion of the corpus. The meetings would end after the corpus was exhausted–approximately 10 years. The trustees included the writer, Barry Goldwater, Republican senator John Tower, former Ohio governor and senator Frank Lausche, South Carolina senator Strom Thurmond, former dean of Notre Dame Law School Clarence (Pat) Manion, George Benson, and Edgar Eisenhower, th older brother of Dwight D. Eisenhower; Louis Nichols, senior aide to J. Edgar Hoover, was later voted in. They all gathered in Wichita and selected their beneficiaries. For 7 years, full attendance at the annual meeting was unbroken. When Goldwater could not attend the 7th meeting, the writer, afraid that Goldwater had forgotten to donate to the writer's pet cause, the Philadelphia Society, forged a telegram to the other trustee members requesting the donation be made. Goldwater later thanked him. The meetings ended in 1977. …John Gaty was responsible for the election of Ronald Reagan. Over ten years, the trust had distributed a total of $1,300,000 to a total of 56 conservative enterprises. …Millions of words were printed, spoken, and preached by recipients of Gaty money. Sweaty work, but revolutions take time. View Article William F. Buckley Bio All work & You Might Like Jigsaw Puzzle Strongbox Submissions Goings On App About Us Caption Contest The New Yorker Festival ✕ The New Yorker Strongbox Strongbox is a new way for you to share information, messages, and files with our writers and editors and is designed to provide you with a greater degree of anonymity and security than afforded by conventional e-mail. 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If a writer or editor at The New Yorker wants to contact you about the information you have submitted, he or she will leave a message for you in Strongbox. These messages are the only way we will be able to reach you, and this message can only be accessed using your code name. Our privacy promise The New Yorker's Strongbox is designed to let you communicate with our writers and editors with greater anonymity and security than afforded by conventional e-mail. When you visit or use our public Strongbox server at http://strngbxhwyuu37a3.onion, The New Yorker and our parent company, Condé Nast, will not record your I.P. address or information about your browser, computer, or operating system, nor will we embed third-party content or deliver cookies to your browser. Strongbox servers are under the physical control of The New Yorker and Condé Nast. Strongbox is designed to be accessed only through a "hidden service" on the Tor anonymity network, which is set up to conceal both your online and physical location from us and to offer full end-to-end encryption for your communications with us. This provides a higher level of security and anonymity in your communication with us than afforded by standard e-mail or unencrypted Web forms. Strongbox does not provide perfect security. Among other risks, if you share your unique code name, or if your computer is compromised, any activities, including communications through Strongbox, should be considered compromised as well. The system is provided on an "as is" basis, with no warranties or representations, and any use of it is at the user's own risk.


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Rockstar News
Jeremy Seewer signs two year extension with Rockstar... / Jun.23.2014
Team Suzuki Press Office – June 23.
Rockstar Energy Suzuki Europe has confirmed a contract with 'rookie of the season' Jeremy Seewer for the Swiss to remain in factory 'yellow' with the RM-Z250 for 2015 and 2016.
The 19 year old has been connected to the manufacturer since his early teens and currently stands an impressive 10th in the FIM MX2 World Championship standings after 11 of 17 rounds into his maiden Grand Prix campaign.
The deal was agreed prior to the team's home GP this weekend at Teutschenthal but the contract was signed at the Talkessel circuit and in the presence of Suzuki International Europe General Manager Jan Breckwoldt. Seewer will pair-up with Glenn Coldenhoff for the 2015 FIM term as the Dutchman moves into the MXGP category with a RM-Z450 and promising talent Brian Hsu will step into European EMX250 with some possible Grand Prix appearances part of the plan.
"This was always going to be a good move for me and a natural one," said Seewer, who also has an option to stay with the Suzuki outfit for 2017 and for what will be his final year in the MX2 class under the current 23 age limit rules. "A big part was making sure that we have the best equipment to go into our next seasons together and this was something we could work out quite easily. I want to continue to learn and grow with the team: 2015 will be my first as a real, full-time Pro and it will be pretty exciting!"
"Jeremy has been on a Suzuki and supported by us since his was 13 years old so it was the next move to make sure he continues his path to the top as part of our project," commented Breckwoldt. "He knows the bike and the technology, knows the team and knows the brand. He has been limited with the time and energy he could put into his racing but has done really well in the circumstances, mixing his school and competition especially this first year in GPs. We are happy he is staying onboard, and to deal with his family who have been so careful and professional about his development into the athlete we see today," he added.
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|Feature Articles
Implementing proper statistical methods ensures the development of safe and effective assays.
|Figure 1. A sample calibration curve showing calibration using a linear fit to a standard curve. Using the regression equation obtained from the linear regression, one can predict the concentration of an analyte in a corresponding unknown sample (click to enlarge).
The key statistical objective in IVD device evaluation is establishing performance criteria while minimizing bias and maximizing precision. While the statistical considerations and methodologies required for such evaluation contribute to this objective, they vary throughout the IVD product development process.
Although clearly separate, the assay development and validation phases are often erroneously folded into one. An assay's development phase requires continuous evaluation that should be clearly distinct from the validation phase. The regulatory and statistical requirements for assay development and validation are different. Understanding the differences between them is crucial for discussing the statistical considerations in each phase.
Utilizing good statistical practices early in an assay's development will ensure not only that the regulatory requirements are met but also that a solid body of knowledge exists regarding the device's performance. Furthermore, confidence in the performance profile of an assay can potentially affect its clinical evaluation.
Assay Development versus Assay Validation
What Is Assay Development. During the assay development, or assay optimization, phase, an analytical process or idea is defined and optimized into a robust and reproducible device that delivers results as intended. The majority of assays can be categorized into one of the following three types: qualitative, semiquantitative (qualitative assays based on a quantitative determination in which a clinically meaningful gradation of results exists), and fully quantitative. One optimization strategy for fully quantitative and semiquantitative assays is using a calibration curve. Another common optimization technique for semiquantitative assays involves using receiver operating characteristic (ROC) curves.
An assay's evolution begins with a clearly desired objective. Whether for basic research or clinical purposes, an assay's intended use becomes the anchor to which all optimization and validation activities are set. Optimizing an assay involves choosing its optimal format. With the intended use in mind, a new assay's appropriate performance characteristics are then defined. Although a number of performance characteristics, such as stability, accuracy, and precision, should be reviewed in all assays, other individual characteristics such as robustness and reproducibility may not be as important, depending on the device's intended use.1,2
|Figure 2. Graphical patterns (residual plots) of four regression fits: a) normal pattern, b) nonlinear kinetics, c) regression outlier, and d) heterogeneity of variance. Examples of residual patterns associated with a proper regression fit and three commonly occurring improper fits. The y-axis is residuals or the difference between the observed value (Yi) and the predicted value E(Yi) from the regression line. The x-axis is predicted value (click to enlarge).
The maturation, or optimization, phase is a continuous cycle that begins with defining these initial performance characteristics, and continues until the performance metrics are established and there is confidence in the results that are obtained from the assay. As a device prototype is being finalized, the final stages of assay development focus on the initial feasibility of manufacturing and marketing the device. Once a final optimized and feasible prototype design is completed, it proceeds to assay validation. The culmination of any assay development involves drafting a development report.
What Is Assay Validation. After successfully completing the development phase and prior to implementation, an assay must undergo a validation period. Validation can begin only after the assay design is set and the test parameters have been established. Based on the data obtained during the development phase and with the help of sound judgment, a validation protocol is prepared. Such a protocol should include experiments that confirm those assay parameters deemed important during the design period and test whether the device meets the performance criteria for its intended use. Some test parameters that could be included in the validation protocol are accuracy, precision, linearity, and specificity. The protocol must also include predefined acceptance criteria for each of the assay parameters.
If an assay successfully passes all criteria in the validation protocol, a validation report should be prepared at the conclusion of this phase. Such a report should outline the experiments performed, any deviations (with justifications) from the protocol, and the results of the evaluations.
Delineating Assay Development and Validation. An assay cannot fail in the development or optimization phase. If an assay does not meet the criteria during development, it either gets reoptimized until it can achieve acceptable performance standards or is rejected for its intended use. However, an assay can fail in the validation phase. If an assay does not meet the predefined acceptance criteria during validation, further development is required. After determining and resolving the cause of the failure, an assay should be reoptimized. Once satisfactory performance is achieved, an assay will then be tested under a new validation protocol. The validation results certify that an assay is fit for use.
Statistical Considerations in Assay Development
|Figure 3. Examples of three ROC curves showing excellent, good, and worthless assays plotted on the same graph. The accuracy of an assay depends on its ability to separate the group being tested into those with and those without the condition of interest. The accuracy can be measured by the area under the ROC curve (1 = perfect test, 0.5 = worthless test) (click to enlarge).
Statistics play a crucial role in understanding assay results and developing experimental strategies for optimizing the device. The statistical methods employed during assay optimization are generally simple and understandable. However, assay developers should pay careful attention to ensure that these methods are implemented correctly and the results are appropriately interpreted.
Analytical Method Calibration. Many quantitative or semiquantitative assays may require comparing the results to a standard curve, or in other words, they require calibration. Although the same statistical principles apply to all assays, those devices in which quantitation depends on a standard curve present unique challenges.
In order to quantify the amount and activity of an analyte in a sample, calibration to a standard may be required. A series of samples with known amounts of an analyte are run on an assay. The assay results are then plotted against the reference standards, and a curve is statistically fitted to the data. In some cases, a calibration curve with a simple linear fit may be generated (see Figure 1).
Although the example in Figure 1 shows a linear fit, most biological assays do not exhibit linearity across their complete range. The strategy in such cases should be to assess an assay's linear range and establish a standard curve within this range. The linear range can be determined graphically using a plot similar to the example above. A number of linear fit techniques are available, although the least-squares approach is often sufficient. A simple transformation of the data (such as a log, log-log, square root transformation) may also be required to obtain a linear fit. However, if an assay does not perform in a linear fashion throughout its analytical range (i.e., typical transformation methods are not adequate) and graphical plots show a sigmoidal relationship, the standard curve may be able to be modeled on the four-parameter logistic regression equation.3
In order to verify the goodness of fit of a linear equation, common regression diagnostics should be applied. Although no standard exists, a regression line's fit is commonly measured using a threshold value of the coefficient of determination (r2) associated with the regression fit. An assay that does not meet this criterion will be deemed invalid in the validation phase and should undergo further development. While relying on r2 as a goodness-of-fit measure, assay developers should take caution to ensure that the standard curve does exhibit a linear response, that no regression outliers exist, and that the data have no systematic bias or heterogeneous variability.4 Such features can be elicited using common graphical diagnostics techniques such as residual plots (see Figure 2). While quantitative statistical tests of curvature, outliers, and patterned residuals are also available, they should be understood prior to use.5 Once the validity of the regression line has been established, predicted concentrations can be determined using inverse regression techniques.
|Figure 4. A sample Pareto plot from a 23 factorial experiment showing the absolute effects of factors X, Y, and Z as presented in Table I on the activity level of the analyte as well as the effect of 2-factor and 3-factor interactions on the activity level of the analyte (click to enlarge).
Receiver Operating Characteristic (ROC) Curves. When developing semiquantitative assays that can be compared with a gold-standard in which true disease states are known, ROC curves should be used.6 An ROC curve is a plot of the true-positive rates against the false-positive rates for the different possible cut points of a test (see Figure 3). An ROC curve shows the trade-off between the sensitivity and specificity of an assay.6 The closer a curve follows the y-axis and the top border of the graph sheet, the more accurate the test. Another way to express it is that the area under an ROC curve is a measure of assay accuracy. The Clinical and Laboratory Standards Institute (CLSI; Wayne, PA) has established guidelines (in document GP10) that provide further guidance on the use and utility of ROC curves.7
Assay Optimization. The goal of assay optimization is establishing a plan for evaluating the factors that may affect a device's performance. The factors that may affect an assay are temperature, humidity, sample contaminants, the matrix tested, and reagent composition. Assay developers should study these factors alone and in combination to assess their effects on the device's accuracy, precision, repeatability, and cross-reactivity.
The most commonly chosen experimental design for assay optimization is a factorial design (see Table I). Depending on the number of factors to be tested, such an experiment will employ either a full factorial or fractional factorial design. A full description of factorial experiments can be found in many statistical data analysis texts.8 Depending on the experimental scenario, other methods such as a full-randomized design or a randomized block design may be employed.8
|Figure 5. An example of a boxplot (also known as a box-and-whisker plot) showing outliers in the dataset, which are identified using Tukey's rule (click to enlarge).
A factorial design allows for simultaneous evaluation of multiple factors that might influence an assay's performance. (Fewer than five factors use a full factorial design, more than five factors use a fractional factorial design.) When using a factorial design in an experiment, the runs should be performed in a random order. Fractional factorial designs are used when the number of runs in a full factorial design becomes too tedious and when resources are not available to complete a full factorial design. Since deciding which runs to choose and which to leave out can be complex, researchers should consult the relevant references to ensure that the runs are appropriately selected.7
Once an appropriate factorial design is chosen, the experiment can be conducted. The results of the experiment can be graphically summarized using a Pareto plot (see Figure 4). A Pareto plot shows the effects of any given factor compared with all other factors, including possible factor interactions, in an ordered fashion.
Statistical Considerations in Assay Validation.
|Table I. An example of a 23 factorial experimental design studying the effect of three hypothetical factors (X, Y, Z) on the activity level of the analyte (click to enlarge).
Unlike the statistical and experimental methods for assay development, which are not well defined, the statistical methods for assay validation and data analysis have been established and widely published.
Assay Performance Metrics. As part of its Harmonized Tripartite Guideline, the International Conference on Harmonization (ICH; Geneva) released the following two documents: "Text on Validation of Analytical Procedures" and "Validation of Analytical Procedures: Methodology."1,2 These documents provide detailed definitions of appropriate validation parameters and suitable evaluation methods. These documents also provide the metrics of assay performance and their definitions (see Table II).
When reviewing the statistical considerations for assay validation, the standard validation parameters should be grouped into two areas: the measurements themselves and the variability in those measurements (see Table II). The validation metrics related to an analytical assay's measurements are accuracy, linearity, and specificity. The validation metrics related to the variability of an analytical assay are precision, robustness, range, limit of quantitation, and limit of detection.
|Table II. A list of accepted assay performance metrics and their definitions as well as their relation to assay measurement or assay variability as presented in the ICH Tripartite Guideline and the NCCLS guidelines (click to enlarge).
The CLSI guidelines provide a solid methodology for validating an assay against the chosen parameters.7 Although specialized software is available for analyzing the data from assay validation experiments, in accordance with CLSI methods, such data analysis can also be performed by using standard elements in Excel and any statistical software package.7 The most common statistical methods used in assay validation are precision analysis, linearity analysis, and methods comparison.
Precision Analysis
Every precision analysis must begin by setting a precision goal or precision acceptance criterion. The experiment involves repeated measuring of a known amount of a sample analyte. The larger the number of replicates measured during the experiment, the greater the accuracy of the precision estimate. The results of such analysis should be reviewed for the presence of outliers. Since outliers cannot be defined arbitrarily, they should be assessed using acceptable methods such as Tukey's rule.9
Tukey's rule proposed that observations lying at least 1.5 times the inter-quartile range (the difference between the first and third quartiles) beyond one of the quartiles could be removed from an analysis. Such observations can be discerned by summarizing data using a boxplot (see Figure 5). However, during the assay development stages, removing such outliers is not advisable, unless a well-founded reason is identified. At the same time, outliers resulting from operator error, contamination, or mechanical failure should be removed.
|Table III. A summary of guidelines and references for early assay development (click to enlarge).
Precision is determined by calculating the mean, the standard deviation with a 95% confidence interval, and the coefficient of variation (CV) of the data. Although the CV has been widely used, it is not useful in all cases. For example, in negative analyte cases in which the signal approaches zero, the mathematical result will be an infinitely large CV that does not correctly reflect the assay's precision. Presenting the standard deviation and its corresponding 95% confidence interval is preferred. The pass-fail criteria for this type of precision analysis involve assessing whether or not the standard deviation of the estimate exceeds the precision goal.
In addition, other more-complex parameters for within-run precision and total-run precision are required for assay validation. The experimental process required to obtain data for such parameters is defined in the CLSI guidelines in document EP5.7 To assess data outliers using this method, guidelines necessitating a preliminary run should be followed. Once the data are collected for the course of the experiment, it should be assessed using variance component analysis and analysis of variance to determine within-run and total-run precision, as well as the 95% confidence intervals. The results are then scrutinized against the predetermined precision acceptance criteria.
Linearity Analysis
Linearity analysis involves using an assay to test approximately 6–11 samples, preferably with multiple replicates of each specimen. This type of analysis assesses three assay performance metrics: accuracy, linearity, and reportable range. The acceptance criteria for these parameters should be defined before beginning an experiment. For example, the acceptable parameters for accuracy are defined in terms of total allowable error, which is comprised of two components: systematic error and random error. While these error components can be individually predefined, doing so is not necessarily required. For the assay's reportable range, the acceptable parameters should reflect the device's analytical range. The degree of linearity of the assay results can be predefined by an acceptable goodness-of-fit statistical test range. However, as indicated in the CLSI guidelines in document EP6, using the rule of thumb, "if it looks like a straight line," is also adequate.7 In general, the pass-fail criteria for the assay performance metrics involve assessing whether the results are sufficiently close to the predefined acceptance level.
Methods Comparison
Traditional methods comparison begins with setting either appropriate acceptance criteria for methods correlation or standard criteria for the slope and intercept. Methods comparison involves selecting two comparative methods, defining their standard deviations, and analyzing 20–50 specimens using both methods. The key point in traditional methods comparison is ensuring that the sample measures cover the full reportable range. Replicates are not usually performed in traditional methods comparison, and assay developers should take caution in analyzing results in which replicates were taken because assumptions of independence will be void.
Any outliers can be dealt with through one of two methods. Although not preferable, the first removes the outliers by using a method, such as Grubb's test, to identify them.10 The second uses regression methods, such as Passing-Bablok regression, that are not distorted by outliers.11
With any statistical software package, assay developers can compute the slope, the intercept, and their associated 95% confidence intervals. Two methods are identical if the 95% confidence interval (CI) for the slope includes 1.00, and the 95% CI for the intercept includes 0. Methods correlation must also meet or exceed the prespecified level.
In addition to traditional methods comparison, two special cases exist for which specific CLSI guidelines have been written: document EP9 for comparing two methods with a 1:1 relationship, and document EP12 for comparing two qualitative methods.9
The statistical considerations for assay development and assay validation are important to keep in mind during product development. Whether used in basic research or clinical diagnosis, assays require vigilant development processes to ensure that the devices will consistently perform to specifications and that they will be deemed safe and effective for their intended use after validation. Just as good manufacturing practices (GMP) are required during the development of new IVDs, manufacturers and researchers alike should also conform to good statistical practices.
The methods presented in this article are not meant to represent an exhaustive review of the available techniques, but rather a general guide to governing principles in early assay development. Consulting a statistician may offer IVD companies better and more-tailored approaches to their particular assay development.
Regardless of the approach, following good statistical practices will ensure that an assay is validated with the appropriate methodologies. In addition, using sound statistical methodologies during assay development may lead to reduced development time and reduced overall cost. A number of Web sites provide useful guidelines and references for early assay development (see Table III).
1. "Text on Validation of Analytical Procedures (Q2A)," the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Web site (Geneva: 1994 [accessed 23 November 2004]); available from Internet: www.ich.org/MediaServer.jser?@_ID=417&@_MODE=GLB.
2. "Validation of Analytical Procedures: Methodology (Q2B)," the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Web site (Geneva: 1996 [accessed 23 November 2004]); available from Internet: www.ich.org/MediaServer.jser?@_ID=418&@_MODE=GLB.
3. A DeLean, P Munson, and D Rodbard, "Simultaneous Analysis of Families of Sigmoidal Curves: Application to Bioassay, Radioligand Assay, and Physiological Dose-Response Curves," American Journal of Physiology 235 (1978): 97–102.
4. F Anscombe, "Assay Development," Journal of the American Statistical Association 27 (1973): 17–21.
5. V Barnett and T Lewis, Outliers in Statistical Data (New York: Wiley, 1978), 252–256.
6. "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostics Tests; Draft Guidance for Industry and FDA Reviewers," the FDA Web site (Rockville, MD: 2003 [accessed 12 January 2005]); available from Internet: www.fda.gov/cdrh/osb/guidance/1428.html.
7. "CLSI Evaluation Protocols (EP05 through EP21)," the Clinical and Laboratory Standards Institute Web site (Wayne, PA: 2004 [accessed 2 February 2005]); available from Internet: www.nccls.org.
8. L Ott, An Introduction to Statistical Methods and Data Analysis, 4th ed. (Florence, KY: Wadsworth Publishing, 1988), 870–891.
9. "Tukey's Outlier Filter," the RoyaltyStat Web site ([accessed 12 January 2005]); available from Internet: www.royaltystat.com/tukeysoutlier.cfm.
10. GraphPad QuickCalcs, "Grubb's Test for Detecting Outliers," the GraphPad QuickCalcs Web site (2004 [accessed 23 November 2004]); available from Internet: www.graphpad.com/quickcalcs/GrubbsHowTo.cfm.
11. MedCalc Manual, "Method Comparison: Passing & Bablok Regression," the MedCalc Web site (Mariakerke, Belgium: 2004 [accessed 23 November 2004]); available from Internet: www.medcalc.be/manual/mpage06-12b.php.
Anastasia N. Derzko is a biostatistician at Spectral Diagnostics Inc. (Toronto). She can be reached at email@example.com.
Copyright ©2005 IVD Technology


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Playing #Smallworld #tabletop #gaming w/ @magiceltrever @thereclinerjockey (at The Geek Palace)
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Small World! I played this game once, really enjoyed it, then forgot the name. And how I know it again! You have my...
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text:
aidan: why did you say I was cool?
me: because you listen to music that's cool you're just cool girl
aidan: it's just pimple
me: oh my god... what did you say?
aidan: pimple...?
me: IT'S PITBULL OH MY GOD AIDAN
aidan: pimple?
me: no pitt bull like the dog a pittbull
aidan: oooooh okay
-a few minutes later-
aidan: i like all of pimples songs
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Norse Projects x Hestra Staale Gloves
Norse Projects source the high-quality glove offerings of Hestra to produce a small run of leather gloves. Since 1936, Hestra has been outfitting much of Scandinavia with its gloves as Norse Projects works to create the Staale model. The gloves feature leather exteriors with sheepskin liners and come in three colors. Available through End.
Date: Dec 7, 2010 / Views: 17 / Author: Eugene Kan


text: Greetings again, I was referring to *sites* that were flood prone. However, if the area is having a drought a little water might be nice. Event capital of the southern region now there's a thought. Yea, and the crowds would know the way by heart and no signs would be needed. Soon, people would just move here so as to be closer to the site. And our population would sky rocket. Yes, yes. Another *evil grin* with wiggling eye brows too. Gilli -----Original Message----- From: Pug Bainter <pug at pug.net> To: southern at Ansteorra.ORG <southern at Ansteorra.ORG> Date: Tuesday, February 23, 1999 6:16 PM Subject: Re: SR - Interesting Idea..... >Bob Dewart (gilli at seacove.net) said something that sounded like: >> We have seven groups in the region: Bjornsborg, Bryn Gwlad, Ffynnon Gath, >> Middleford, Raven's Fort, Shadowlands and Tempio (it would be eight if we >> include Emerald Keep). >[...] >> Weather is a possible factor each event faces. I would hope flood prone >> areas would be avoided. > >Hmmm. Of the 7 in the region, I think Bjornsborg, Bryn Gwlad, Ffynnon >Gath, Raven's Fort and Tempio have all used sites that have "flooded" >out in the last year or so. Some of these unfortunately even during >events. > >That leaves us with Middleford and Shadowlands hosting all of the events. > >Hmmm. Sounds good to me. *evil grin* > >Ciao, > >-- >Phelim "Pug" Gervase | "I want to be called. COTTONTIPS. There is something >Barony of Bryn Gwlad | graceful about that lady. A young woman bursting with >House Flaming Dog | vigor. She blinked at the sudden light. She writes >pug at pug.net | beautiful poems. When ever shall we meet again?" > Note: The views do not reflect the SCA nor the Kingdom of Ansteorra. >=========================================================================== = >Go to http://lists.ansteorra.org/lists.html to perform mailing list tasks. > ============================================================================ Go to http://lists.ansteorra.org/lists.html to perform mailing list tasks.