## Protocol Section
### Identification Module
**NCT ID:** NCT04926779

**Brief Title:** Study Utilizing BIOZEK COVID-19 Antigen Rapid Test

**Official Title:** Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test: Comparison of Biozek COVID-19 Antigen Rapid Test Results Performed on Self-collected Samples by the Subjects, to Results of COVID-19 RT-PCR as a Standard of Care

#### Organization Study ID Info
**ID:** Biozek-ARTC-US/002/4-12-2021
#### Organization
**Class:** INDUSTRY
**Full Name:** Mach-E B.V.
### Status Module
#### Completion Date
**Date:** 2022-11-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-20

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-11-04

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-12-20

**Type:** ACTUAL

**Results First Submit Date:** 2023-11-04

**Results First Submit QC Date:** 2023-12-17

#### Start Date
**Date:** 2021-05-24

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2021-06-15
**Type:** ACTUAL
**Study First Submit Date:** 2021-06-11
**Study First Submit QC Date:** 2021-06-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Mach-E B.V.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) on samples that are self-collected; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results.

### Conditions Module

**Conditions:**

- Covid-19 Testing

**Keywords:**

- Covid-19

- Antigen

- Rapid

- Test

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 185

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Self-collection of nasopharyngeal and saliva samples and self test performance - Biozek Covid-19 Antigen Rapid Test (Saliva) and Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab). Both procedures are supervised by trained study personnel.

**Name:** Biozek Covid-19 Antigen Rapid Test (Saliva)

**Other Names:**

- Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** The Biozek Antigen Rapid Tests performed by subjects on the self-collected, oral fluid samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula.

Specificity was calculated using (TN/TN+FP)\*100% formula.

**Measure:** Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva)

**Time Frame:** 6 months

**Description:** The Biozek Antigen Rapid Tests performed by subjects on the self-collected, nasopharyngeal samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula.

Specificity was calculated using (TN/TN+FP)\*100% formula.

**Measure:** Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment.
* Subjects must be able to understand and willingly sign a written informed consent. Additionally, participants need to meet at least 1 of the criteria listed below:

  * Currently experiencing symptoms of COVID-19.
  * Be clinically diagnosed or suspected to have COVID-19.
  * Recent past (3 weeks) exhibited symptoms of COVID-19.
  * Be capable of performing a self-collection of a nasopharyngeal sample with use of nasal swab kit.
  * Be capable of performing a self-collection of an oral fluid sample with use of oral fluid collection kit.
  * Interacted with a COVID-19 positive individual.

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria may not be enrolled in this study:

* Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit.
* Cannot perform self-collection of an oral fluid sample with use of oral fluid collection kit.
* Have a deviated nasal septum.
* Cognitively impaired individuals resulting in the inability to provide informed consent

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Flushing

**Country:** United States

**Facility:** Mobile Covid Services LLC

**State:** New York

**Zip:** 11354

**Location 2:**

**City:** Southampton

**Country:** United States

**Facility:** Quality Research and Invention LLC

**State:** New York

**Zip:** 11968

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2021-06-01

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 690053

- Type Abbrev: Prot_SAP

- Upload Date: 2023-11-04T11:22

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2023-11-29

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid)

**Deaths Num At Risk:** 185

**Description:** BIOZEK COVID-19 Antigen Rapid Test performed by subjects on self-collected, oral fluid samples compared to RT-PCR.

**ID:** EG000

**Other Num at Risk:** 185

**Serious Number At Risk:** 185

**Title:** BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid)

**Frequency Threshold:** 0

**Time Frame:** 1 visit - up to 2 hours

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Units:** Participants

### Group

**ID:** BG000

**Title:** BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid)

**Description:** BIOZEK COVID-19 Antigen Rapid Test performed by subjects on self-collected, oral fluid samples compared to RT-PCR.

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 36

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** 18-24 years

#### Measurement

**Group ID:** BG000

**Value:** 128

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** 25-64 years

#### Measurement

**Group ID:** BG000

**Value:** 19

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** 65-87 years

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** Unknown

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 111

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 71

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 182

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** Arabic

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 51

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** Black

#### Measurement

**Group ID:** BG000

**Value:** 74

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** Caucasian

#### Measurement

**Group ID:** BG000

**Value:** 31

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** Hispanic/Latino

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** Indian

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** Native American

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** Unknown

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 185

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 185

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Data was not captured for 3 participants.
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** jstega@optonline.net
**Organization:** Quality Research and Invention LLC
**Phone:** 6462718593
**Title:** Zanetta Malanowska-Stega
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 97.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 97.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The Biozek Antigen Rapid Tests performed by subjects on the self-collected, oral fluid samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula.

Specificity was calculated using (TN/TN+FP)\*100% formula.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva)
**Type:** PRIMARY
**Unit of Measure:** percentage - Sensitivity and specificity
##### Group
**Description:** BIOZEK COVID-19 Antigen Rapid Test performed by subjects on self-collected, oral fluid samples compared to RT-PCR.
**ID:** OG000
**Title:** BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid)
#### Outcome Measure 2
**Description:** The Biozek Antigen Rapid Tests performed by subjects on the self-collected, nasopharyngeal samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula.

Specificity was calculated using (TN/TN+FP)\*100% formula.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)
**Type:** PRIMARY
**Unit of Measure:** percentage - Sensitivity and specificity
##### Group
**Description:** The Biozek Antigen Rapid Tests performed by subjects on the self-collected, nasopharyngeal samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula.

Specificity was calculated using (TN/TN+FP)\*100% formula.
**ID:** OG000
**Title:** BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid)
### Participant Flow Module
#### Group
**Description:** BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) was performed by subjects on samples that were self-collected; In addition, RT-PCR test (performed prior enrollment) results were obtained.
**ID:** FG000
**Title:** BIOZEK COVID-19 Antigen Rapid Test
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 185
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 185
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Has Results:** True