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ADS Biotec, along with its parent company ADSTEC (Japan), is a global leader in the development, manufacture and sale of automated instruments and consumables for use in cytogenetic, pathology and research laboratories.

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Method)

The SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Method) is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen (SARS-CoV-2 N-antigen) in anterior nasal 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 (Colloidal Gold Method) includes all items needed to conduct 25 tests.

SKU: YIG-NS-2501

This test is not for sale and distribution in the US.

The SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Method) uses the colloidal gold method to detect the 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 in the sample forms a complex with the antibody labeled with colloidal gold. This complex migrates along the membrane and reaches the test region (T-line) on which a second antibody against the SARS-CoV-2 N-antigen is applied. Unbound colloidal gold migrate along the membrane to the control region (C-line) and are bound by the control region antibody. If both the T-line and the C-line are red, the test result is SARS-CoV-2 N-antigen positive; if only the C-line is red and no T-line becomes visible, the test result is SARS-CoV-2 N-antigen negative. If 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 swab samples was determined by evaluating different concentrations of heat inactivated viruses and recombinant N protein, respectively.

Cross-reactivity was evaluated by testing commensal and pathogenic microorganisms that may be present in the nasal cavity. The results do not show any cross reactivity.

Sensitivity — Swab: 96.12%
Specificity — Swab: 99.49%

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.

The SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Method) includes the following items needed for testing.

Test time: 15 minutes
Storage temperature: 2-30º C
Shelf life: 18 months

Item Qty
Test cassettes 25 x
Pipettes 25 x
Swabs 25 x
Extraction buffer 25 x
Extraction vials/caps 25 x
Instructions for use 1 x

Collection of Nasal Swab Samples

Test Procedure

Interpretation of Results

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 nasopharyngeal 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: Anterior nasal swab samples.

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

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
      • 2 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
      • Sample vortex mixer

Click here for helpful resources to combat SARS-CoV-2.

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