SARS-CoV-2 Antigen Rapid Test Kit

The SARS-CoV-2 Antigen Rapid Test Kit is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen (SARS-CoV-2 N-antigen) in human serum and nasopharyngeal swab and/or oropharyngeal swab samples. Kits are authorized for sale under CE-IVD in the European Union, and they are backed by our company’s full commitment to continued supply, service and support.

The SARS-CoV-2 Antigen Rapid Test Kit includes items needed to conduct 25 tests.

SKU: YIG-AR-0010 Category:

Description

The SARS-CoV-2 Antigen Rapid Test Kit uses a fluorescence immunochromatography method to detect SARS-CoV-2 N-antigen. The sample to be tested is applied to the sample well of the test cassette. The test is authorized for sale under CE-IVD in the EU. Tests allow for room temperature storage.

The SARS-CoV-2 N-antigen within the sample forms a complex with an antibody labelled with fluorescently-tagged microspheres. This complex then migrates along the membrane from the sample well to reach the test region (T-line) where it then binds to a second imbedded antibody to the SARS-CoV-2 N-antigen. Any unbound fluorescently-tagged microspheres continue to migrate along the membrane to the control region (C-line) and are bound there by the control region antibody. The test result (T-Line) in the test window is illuminated with a UV lamp of wavelength 365 nm. If both, the T-line and the C-line fluoresce, the test result is SARS-CoV-2 N-anti-gen positive; if only the C-line fluoresces and no T-line becomes visible, the test result is SARS-CoV-2 N-antigen negative. When no C-line becomes visible, the test result is invalid, and the sample must be retested with a new test cassette.

The limit of detection for serum samples is determined at 20 TCID50 /mL and the limit of detection for swab samples was determined at 40 TCID50 /mL.

Cross-reactivity was evaluated by testing a panel of microbials that could potentially cross-react with the SARS-CoV-2 Antigen rapid test in serum and swab samples. The results do not show any cross reactivity.

Sensitivity — Serum: 96.77%, Swab: 97.65%
Specificity — Serum: 98.90%, Swab: 99.60%

For full integration and efficient high-volume processing, select from ADS Biotec automated systems including the QuickGene 24S and QuickGene 12S Nucleic Acid Extraction Systems.

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Specifications

Test time: 15 minutes
Storage temperature: 2-30º C
Shelf life: 12 months

The SARS-CoV-2 Antigen Rapid Test Kit includes all items needed for testing.

ItemQty
Test cassettes25
Pipettes25
Swabs25
Extraction buffer 2 (4 mL)
Instructions for use1

Operating Procedures

Serum

Swab

Documents

SARS-CoV-2 Antigen Rapid Test Kit — CE-IVD Declaration of Conformity
SARS-CoV-2 Antigen Rapid Test Kit — Brochure
SARS-CoV-2 Antigen Rapid Test Kit – Serum Samples — Validation Report
SARS-CoV-2 Antigen Rapid Test Kit – Swab Samples — Validation Report

FAQs

Q: What is the intended use of the product?

A: This rapid kit is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen (hereinafter referred to as SARS-CoV-2 N-antigen) in human serum and nasopharyngeal swab and/or oropharyngeal swab samples.

Q: How many procedural steps are there to complete the test using this product?
A: There are six simple procedural steps. Refer to the Instructions for Use (IFU) for more details.

Q: What sample types are used with the product?
A: Human serum, nasopharyngeal swab, and/or oropharyngeal swab samples.

Q: What is the response time?
A: The response time is 15 minutes.

Q: Is there any additional instrumentation required to perform the test?
A: UV light with a wavelength of 365 nm (not provided with the kit). Available separately.

Q: What are the kit components?
A: The kit includes the following:

    • Instructions for Use (IFU)
    • 25 test cassettes
    • 25 pipettes
    • 25 swabs
    • 25 extraction vials/caps
    • 25 extraction buffer vials (4 mL each)

Q: Are there any additional materials required that are not included with the product?
A: The following additional materials are required that are not included with the product:

    • Clock or timer
    • Latex gloves
    • UV light with a wavelength of 365 nm
    • Sample vortex mixer

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