SINGCLEAN rapid COVID-19 antigen test from saliva

Medical device, rapid antigen test

SINGCLEAN COVID-19 rapid salivary antigen test to identify SARS-COV-2 infection.

For professional use!

Rapid antigen test -Advantages:

More convenient use compared to antigen tests for a sample from the nasopharynx.

Non - invasive procedure.

Does not cause discomfort.

Speed ​​- results in 15 minutes.

The evaluation of the test result is performed visually.

Low cost compared to PCR tests.

Accurate diagnostic tool for active infection.

Easy to use and interpret results.

COVID-19 Antigen Test Kit (Colloidal Gold)

For professional use!

Pack of 1 pcs.

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd., 10th Street No. 125, Hangzhou Economic and Technological Development Zone, Zhejiang, China.

The rapid COVID-19 antigen test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in human oral secretions.

The test is for professional diagnostic use only.

Rapid Antigen Test-Purpose:

The COVID-19 Assay Kit (Colloidal Gold Method) is a solid-phase immunochromatographic assay for rapid and qualitative detection of the 2019 new coronavirus antigen in human saliva. This test provides only a preliminary test result. Therefore, all reactive specimens with the COVID-19 test kit (Colloidal Gold Method) must be validated with alternative test method (s) and clinical conclusions.

Rapid Antigen Test-Sampling:

The COVID-19 antigen test kit (colloidal gold) is performed using a saliva swab. The test must be carried out immediately after sampling. Samples should be at room temperature before testing. If samples are to be transported, they must be packaged in accordance with local regulations governing the transport of pathogens. Avoid chewing or swallowing saliva during sampling.

Rapid Antigen Test-Procedure:

Allow the test cartridge, antigen extraction buffer, and sample to reach room temperature (15-30 ° C) prior to testing.

Before taking a sample, make sure that there are no food residues in your mouth. If the patient has just eaten, rinse their mouth or brush their teeth. Remove the swab from the package and hold the swab on your tongue until the tip is soaked in saliva (at least two minutes).

Place the antigen removal tube on the desktop (use the package as a desktop). Squeeze the extraction buffer vial so that the buffer drips freely into the antigen removal tube without touching the edge of the tube. Add all of the antigen extraction solution (buffer) (approximately 450 ul) to the antigen removal tube.

Place the sample swab in the antigen removal tube, in the pre-filled antigen extraction buffer, and swirl the swab approximately 10 times, pressing the swab head against the wall of the tube to allow as much sample material as possible to escape from the swab, then allow to stand for approximately 1 minute.

When removing the swab, press the tip of the swab against the wall to remove as much fluid as possible from the swab. Dispose of used swabs in accordance with biohazardous waste disposal methods.

Place the dropper head on the antigen removal tube, close tightly, and allow to stand for approximately 1 minute.

Remove the test cartridge from the sealed bag and use it as soon as possible.

Place the cartridge on a clean, flat surface.

Add 3 drops (about 100 ul, you can use a pipette) of the liquid mixture to the sample well of the test cartridge and start the timer.

Wait for the test result to be available. The result should be read within 15 minutes. Do not evaluate the result after 20 minutes.

Evaluation of results:

NEGATIVE: If there is only band C and there is no burgundy color in band T, it indicates that no COVID-19 (SARS-CoV-2) antigen was detected in the sample. The result is negative.

POSITIVE: In the presence of a C band, a T band emerges and the test indicates the presence of COVID-19 (SARS-CoV-2) antigen in the sample. The result for COVID-19 is positive.

INVALID: The control line does not appear. Insufficient sample volume or incorrect procedural methods are the most common reasons for the absence of a control line. Review the procedure and repeat the test with a new test. If the problem persists, stop using the test kit immediately and contact your local distributor.