COVID-19 Antigen Test Kit ART Rapid Test Kit

 COVID-19 Antigen Test Kit ART Rapid Test Kit

Product Description

The SARS-CoV-2 Antigen Raid Test is for detection of SARS-CoV-2 antigens. Anti-SARS-CoV-2 monoclonal antibodies are coated in the test line and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-SARS-CoV-2 antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with another
Anti-SARS-CoV-2 monoclonal antibodies in the test region. The complex is captured and forming a colored line in the Test line region. The SARS-CoV-2 Antigen Rapid Test contains anti-SARS-CoV-2 monoclonal antibodies conjugated particles and another
anti-SARS-CoV-2 monoclonal antibodies are coated in the test line regions.

SPECIMEN COLLECTION AND PREPARATION

The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) can be performed using saliva or sputum specimen.
1) Saliva: Prepare a specimen collection container. Make a “Kruuua” noise from the throat, to get out the saliva or sputum from the deep throat. Then spit saliva (about 1-2ml) into the container. Morning saliva is optimal for saliva collection. Do not brush the teeth, eat food or drink before collection the saliva specimen.
2) Tear off the covering film of the assay buffer tube.
3) Suck the saliva from the container and place 5 drops (approx.200ul) of the saliva into the sample collection tube and place the crystal tips on. If sputum specimen, collect the specimen from the patient using provided swab ,rotate the swab 8-10 times.Insert the swab into the tube and squeeze the flexible tube to extrude the specimen from the head of the swab. Make the specimen resolved in the assay buffer sufficiently.

Requirement to the saliva specimen.
– Do not brush the teeth, eat food or drink before collection the saliva specimen.
– Fresh saliva is usually the optimal one for running the assay. In long time storage or frozen specimen, the activity of virus might decrease. It is suggested not to run the assay after 2 hours after collection the fresh specimen. If the specimen was frozen immediately after specimen collection, it is suggested not to keep the specimen more than 2 days.
The loading of virus is very important for the assay. If the CT value>25 by PCR, the sensitivity of the rapid test would be affected apparently.
– The loading of virus in saliva is usually lower than it is in the nasopharyngeal swabs. If negative was found by a saliva test, but the symptoms are looking like a COVID-19 infection, it is suggested to repeat the rapid test with a nasopharyngeal swab testing.

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Take out the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and horizontal surface. Reverse the assay buffer tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer.
See illustration below.

3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.
4. After all tests are completed, 5ml of 75% alcohol by volume should be added to the specimen bag in order to disinfect the remaining specimen.

INTERPRETATION OF RESULTS

- Positive (+): Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the T line region.
*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of SARS-CoV-2 present in the specimen. Therefore, any shade of color in the test line region should be considered positive and recorded as such.
- Negative (-): One colored line appears in the control line region (C). No line appears in the T line region.
- Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

PRECAUTIONS
- For in vitro diagnostic use only. Do not use after expiration date.
- The Test strip should remain in the sealed pouch until use.
- Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
- Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
- The used Test Strip should be discarded according to national, state and local regulations.
- Humidity and temperature can adversely affect results.
STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (2-30°C). The Test Strip is stable through the expiration date printed on the sealed pouch. The Test Strip must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date. The stability of the kit under these storage conditions is 18 months.