Product Overview

The COVlD-19 Antigen Rapid Test Kit (Swab) is a lateral flow immunoassay intended for qualitative detection of nucleocapsid protein antigen in direct nasal swabs, nasopharyngeal swabs or oropharyngeal swabs specimens from individuals suspected of COVlD-19 by their healthcare provider.

Product Specification

Intended use	Detection of SARS-CoV-2
Principle	Fluorescence Immunochromatography
Storage	4-30°C
Shelf Life	36 Months
Reading Time	10~15 Minutes
Relative Sensitivity	96.4%
Relative Specificity	99.9%
Overall Agreement	98.1%

Product Advantages

One step test;
High sensitivity&Specificity;
Fast results：in 10 minutes;
No extra lab equipment;
Easy to store & transport

Ordering Information

Catalog No.

Product Name

Specimen

Format

Pack

Certification

COV Ag-6012

COVID-19 Antigen Rapid Test Kit (Swab)

Nasopharyngeal secretion

Cassette

1Test /Kit

5Tests /Kit

20Tests /Kit

Operation Steps

Sample Collection: Use the provided sterile swab and gently insert it into the sampling site (approximately 2.5 cm, 1 inch). Rotate the swab 5-6 times along the sampling site to collect sufficient epithelial cells.

Sample Processing: Immerse the swab tip into the sample extraction buffer. Rotate and press the swab against the tube wall for 30 seconds to release the sample, then discard the swab properly. Close the extraction tube tightly.

Test Execution: Add the specified volume of processed sample (as indicated in the kit instructions) dropwise into the sample well of the test cassette.

Result Waiting: Allow the test to develop for the recommended time (typically 10-15 minutes) at room temperature. Do not read results after the specified time window.

Result Interpretation

Positive(+): Both the control line (C) and test line (T) appear. The intensity of the T line may vary, but any visible T line indicates a positive result.

Negative(-): Only the control line (C) appears, with no visible test line (T), indicating no detectable antigens.

Invalid: No control line (C) appears, regardless of whether the test line (T) is visible. This may be due to incorrect operation or kit damage; repeat the test with a new kit.

FAQ

Q: How accurate is this antigen test compared to PCR?

A: The test shows high consistency with PCR results, with an overall concordance of 98.1%. Its relative sensitivity is 96.4% (meaning it correctly identifies 96.4% of PCR-confirmed positive cases), and relative specificity is 99.9% (correctly identifying 99.9% of PCR-confirmed negative cases).

Q: What sample type does this test use?

A: The test uses three methods: nasal swab, nasopharyngeal swab, and oropharyngeal swab.

Q: How long should I wait for the test result?

A: You should read the result within the recommended time window (usually 10-15 minutes after adding the sample). Reading results too early or too late may lead to inaccurate interpretations.

Q: Why might my test result be invalid?

A: An invalid result (no control line C) may occur due to improper sample addition, expired kits, or incorrect storage. If this happens, repeat the test with a new, properly stored kit and follow the operating steps carefully.

Q: Does this test meet international quality standards?

A: Yes, the test is CE-compliant, meeting strict European in vitro diagnostic regulations for quality, safety, and performance.

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