Ultimate Detection of Canine Distemper Virus Antibody - SARS-CoV-2 Rapid Test Device

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

QL Biotech, a renowned leader in the biotech industry, presents our advanced SARS-CoV-2 Antigen Rapid Test Device, now designed specifically for self-testing. This device emphasizes our commitment to accuracy and efficiency, enabling users to detect the Canine Distemper Virus Antibody in no time. Endorsed with certificates from reputable organizations such as CE, TGA, ISO13485, and UK Registration, our brand, QL, brings forth a product that stands for high-quality and reliability. We offer various packaging options, from single test packs to packs containing up to 20 tests, catering to individual needs and preferences. Using a simple nasal swab specimen, our SARS-CoV-2 Rapid Test Device provides results in as little as 10 minutes. The importance of acquiring as much secretion as possible for a reliable test result is not lost on us. The package comes with a cassette, sterile nasal swab, buffer, and insert to ensure that you have everything you need for self-testing at your fingertips.

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.




Our test kits are carefully stored and transported between 2-30℃ to preserve their integrity. With a shelf life of two years, QL's SARS-CoV-2 Rapid Test Device can be kept on hand for periodic checks or emergency situations. The focus of QL Biotech is your health and safety, and our products reflect this. Experience high-quality and worry-free self-testing with our SARS-CoV-2 Antigen Rapid Test Device, the moving force in Detection of Canine Distemper Virus Antibody.

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