Swift and Accurate Influenza A+B/COVID/RSV COMBO RAPID TEST 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

QL Biotech, a leader in the biomedical industry, is proud to present our state-of-the-art Influenza A+B/COVID/RSV COMBO RAPID TEST. This revolutionary testing device, designed for utmost accuracy and convenience, is set to convert the way we conduct diagnostic testing for respiratory viruses including SARS-CoV-2 antigen, Influenza A, Influenza B, and RSV. Our test kit is CE, TGA, ISO13485, and UK Registration certified, signifying its conformance to international standards. This simple-to-use package comes with everything you need to conduct the test - a cassette, a sterile nasal swab, a buffer, and an easy-to-follow package insert. The test is conducted using a nasal swab specimen, ensuring minimal discomfort while maximizing the chance of detecting the virus. We've designed this test to be swift, with results appearing within just 10 minutes, optimizing the time taken for diagnosis and subsequent treatment. The QL Biotech Influenza A+B/COVID/RSV COMBO RAPID TEST has two handy pack sizes - Individual, with a single test per pack, or bulk, with packs of 5 and 20 tests available. This product is designed for storage at standard room temperature, between 2-30℃, making it suitable for use in a wide range of environments. It also includes a generous 2-year shelf life, ensuring you can keep the test kits on-hand for whenever they are 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.




It is important to note that specimen collection is a vital part of the process, and it is crucial to collect as much nasal secretion as possible to ensure accurate results. Clear instructions are provided with the kit, guiding users through the collection process to maximize accuracy. Overall, our Influenza A+B/COVID/RSV COMBO RAPID TEST stands out as an embodiment of QL Biotech's commitment to providing cutting-edge, reliable, and convenient diagnostic solutions. Trust in QL Biotech for swift answers when you need them most.

  • Previous:
  • Next: