## Protocol Section
### Identification Module
**NCT ID:** NCT06368479

**Brief Title:** Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings

**Official Title:** A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings

#### Organization Study ID Info
**ID:** CLS-016B
#### Organization
**Class:** INDUSTRY
**Full Name:** bioLytical Laboratories
### Status Module
#### Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-06

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-02

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-04-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-10
**Study First Submit QC Date:** 2024-04-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** bioLytical Laboratories

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of testing the samples on iStatis HBsAg Test at the point of care.

**Detailed Description:** Participants are prospctively recruited and enrolled to participate in the study. The Capillary (fingerstick) whole blood, and venous whole blood samples (in serum separating tube (SST) and Ethylenediaminetetraacetic acid (EDTA) tube) are collected by a healthcare professional. Serum and plasma samples will be extracted through laboratory processing of the collected serum separating tube and Ethylenediaminetetraacetic acid VWB, respectively. The collected samples of capillary will be tested on iStatis HBsAg Test. The collected Ethylenediaminetetraacetic acid and serum separating tube VWB will be shipped to the central laboratory to appropriately process and extract serum and plasma samples. Ethylenediaminetetraacetic acid VWB, plasma and serum will be tested on iStatis HBsAg Test in the laboratory. An aliquot of the obtained plasma sample will be further tested for reference and confirmatory testing.

The results from iStatis HBsAg Test results will not be used for participant management decisions.

### Conditions Module

**Conditions:**

- Hepatitis B

- Hepatitis B Infection

**Keywords:**

- Hepatitis B rapid test

- Hepatitis B infection

- Hepatitis B iStatis test

- Hepatitis B point of care test

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** SCREENING

#### Enrollment Info

**Count:** 4400

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Capillary (fingerstick) blood samples are tested using iStatis HBsAg Test onsite.

**Intervention Names:**

- Device: iStatis HBsAg Test

**Label:** iStatis Testing Onsite

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Venous whole blood collected in Ethylenediaminetetraacetic acid tube, plasma and serum samples are tested using iStatis HBsAg Test

**Intervention Names:**

- Device: iStatis HBsAg Test

**Label:** iStatis Testing In Lab

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Either serum or plasma sample will be tested on Abbott Architect HBsAg Qualitative Confirmatory Assay and ADVIA Centaur (depending on the test result outcome).

**Label:** Reference Test

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- iStatis Testing In Lab

- iStatis Testing Onsite

**Description:** Capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples to be tested on the iStatis HBsAg Test at the point of care setting.

**Name:** iStatis HBsAg Test

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** To evaluate the device performance i.e. diagnostic sensitivity and diagnostic specificity of the iStatis Hepatitis B surface Antigen (HBsAg) Test compared to comparator assay.

**Measure:** iStatis Performance

**Time Frame:** 3 Months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participants/subjects (males, females, and pregnant women) getting tested for Hepatitis B virus for one or more of the following reasons:

  * at risk for Hepatitis B virus
  * having signs and symptoms indicative for Hepatitis B virus
  * Routine testing Unknown or other reasons will be captured
* Participants/subjects of 18 years or older and, who are able to give/sign the informed consent.

Exclusion Criteria:

* Participant younger than 18 years old
* Participants unable to provide written informed consent

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** asubramanian@biolytical.com

**Name:** Ana Subramanian

**Phone:** 16042046784

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hillcrest

**Contacts:**

***Contact 1:***

- **Email:** cheriec@epicentre.org.za

- **Name:** Cherie Cawood

- **Phone:** +27828202955

- **Role:** CONTACT

**Country:** South Africa

**Facility:** Epicentre Health Research

**State:** Kwazulu Natal

**Status:** RECRUITING

**Zip:** 3650

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007239

- Term: Infections

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018347

- Term: Hepadnaviridae Infections

- ID: D000004266

- Term: DNA Virus Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9595

- Name: Hepatitis B

- Relevance: HIGH

- As Found: Hepatitis B

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20487

- Name: Hepadnaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006509

- Term: Hepatitis B

- ID: D000006505

- Term: Hepatitis

### Intervention Browse Module - Browse Branches

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7662

- Name: Edetic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M7543

- Name: Pentetic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
