Rapid Test Flu a B: Fast & Accurate SARS-CoV-2 Antigen Self-Testing by QL Biotech

Short Description:

The SARS-CoV-2 Antigen Rapid Test device is a rapid visual immunoassay for the qualitative, presumptive detection of SARS-CoV-2 antigens form Nasal swabs specimens. A nasal swab sample can be self-collected by an individual aged 15-70 years. People between the ages of 15 and 70 who are unable to collect samples by themselves may be assisted by other adults. The test is intended for self-testing use as an aid in the rapid differential diagnosis of acute SARS-CoV-2 virus infection.


Product Detail

Product Tags

Embark on a journey of fast and precise self-diagnosis with QL Biotech's SARS-CoV-2 Antigen Rapid Test Device, a revolutionary solution for Rapid Test Flu a B. This CE, TGA, ISO13485, and UK registered product ensures the highest standards of testing from the comfort of your own home. Our kit comes in packs of 1, 5, or 20 tests, each comprising a cassette, a sterile nasal swab, a buffer, and a package insert. With an easy-to-understand manual included, you can complete the test by using a simple nasal swab specimen, providing convenience and privacy, while minimizing exposure to others. Unlike most medical tests that require a professional to administer, our Rapid Test Flu a B package includes everything you need to conduct the test yourself. One of the distinguishing features of our Rapid Test Flu a B device is its quick and precise result generation. In just 10 minutes, you can access your results, alleviating unnecessary stress and worry associated with waiting for test results. Our test kits are also designed for efficient storage and a long shelf-life of two years, ensuring you can keep them on hand for whenever needed.

PRODUCT SPECIFICATION

Brand

QL

Certificate

CE / TGA / ISO13485/UK Registration

Specimen

Nasal swab

Pack

1 test

5 tests

20 tests

Reading Time

10 Minutes

Contents

Cassette, Sterile Nasal Swab, Buffer ,Package Insert

Storage

2-30℃

Shelf Life

2 Years


Specimen Collection

It is important to obtain as much secretion as possible. Therefore, to collect a nasal swab sample, insert the sterile swab into the nostril that presents the most secretion under visual inspection. Using gentle rotation, push the swab until resistance is met at the level of the turbinates (less than one inch into the nostril). rotate the swab 8-10s for five times at least against nasal wail.


PROCEDURE

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

  • ● Wear the protection equipment. Remove the test from its sealed pouch, and place it on a clean, level surface. For best results, the assay should be performed within one hour.

Place the swab specimen into the Extraction Tube. Roll the swab at least 10 times while pressing the swab against the bottom and side of the Extraction Tube. Roll the swab head against the inside of the Extraction Tube as you remove it. Try to release as much liquid as possible. Dispose of the used swab into the Disposal Bag considered  biohazard waste.


● Put on the tube tip, then add 3 drops (100ul) of extracted sample into the sample well (S). Do not handle or move the Test Device until the test is complete and ready for reading.

  • ● As the test begins to work, color will migrate across the membrane. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
  • ● Dispose all assayed equipment (cassette, buffer and so on) into the Disposal Bagconsidered as biohazard.

PERFORMANCE CHARACTERISTICS

Test results of the candidate kit and the reference kit are summarized in 2×2 table below.

 

Vitassay qPCR SARS-CoV-2

Total

Positive

Negative

SARS-CoV-2 Antigen Rapid Test Device

Positive

100

0

100

Negative

10

450

460

Total

110

450

560

 

Statistic

Value

95% CI

Sensitivity

90.91%

(83.92%~95.55%)

Specificity

100.00%

 (99.18%~100.00%)

Total coincidence rate

98.21%

 (96.74%~99.14%)

 

The 95% confidence intervals of sensitivity, specificity, the total coincidence rate is calculated based on the binomial distribution.




While conducting the test, it's vital to obtain as much nasal secretion as possible. This will ensure the most accurate results from your Rapid Test Flu a B. These tests are stored best between 2-30℃, a common temperature range in most households, facilitating easy storage. QL Biotech's Rapid Test Flu a B guarantees a seamless, user-friendly experience, changing the face of self-conducted tests. We are committed to delivering reliable, fast, and accurate results, empowering you to take control of your health.

  • Previous:
  • Next: