Common List COVID-19 Omicron Strain Test Antigen Rapid Test

Common List COVID-19 Omicron Strain Test Antigen Rapid Test

Recently, the Sars-CoV-2 new variant Omicron (B.1.1.529) strains were spreading from South Africa and across the world and makes it more difficult to prevent and control. The mutation sites on the nucleocapsid protein (N protein) are located at DEL31/33, P13L, R203K, and G204R, where are all out of the epitope region (N47-A173, NTD region) recognized by our antibody pairs. Thus, the Sars-CoV-2 Antigen Rapid Test (COVID-19 Ag) is theoretically competent for the detection of the Sars-CoV-2 new variant Omicron strains.

Meanwhile, our Sars-CoV-2 Antigen Rapid Test (COVID-19 Ag) is still working on the WHO concerned variant stains on their N proteins, including UK variant B.1.1.7, Brazil variant P.1, South Africa variant B.1.351, and India variants B.1.617 and B.1.617.2.

Brief Introduction

The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV-2 in human nasopharyngeal, oropharyngeal and nasal specimen

1. Convenient operation: the operation steps are sample, no special equipment is required, the sample does not need special processing, the test results can be directly interpreted with the naked eye, and there is no special skill requirement for the operator

2. Fast and quick: only 10-15 mins will produce results. While other methods such as ELISA require 1-2 hours， PCR takes longer.

3. Strong specificity: because the technology is mostly labeled with monoclonal anyibodies, it determined that it only detects a certain antigenic determinant, so it has very good specificity.

4. The sensitivity is accurate:The sensitivity of throat, nasal cavity, and saliva detection is as high as 90% or more

5. Convenient to carry: since the colloidal gold labeling protein is a physical binding process, the binding is firm and rarely causes changes in protein activity. Therefore, the reagent is very stable and not affected by externnal factors such as temperature. It can be carried with you for monitoring at any time.

6. Safety and environmental protection: Compared with other detection methods, immune colloidal gold technology greatly simplifies the operation. No harmful substances such as radioisotopes and o-phenylenediamine are involved in the test, so it will neither harm the health of the operator nor pollute the environment. , Has the safety that can’t be compared with the detection methods such as radioisotope or enzyme label.

SPECIMEN COLLECTION AND PREPARATION

The SARS-CoV-2 Antigen Rapid Test (COVID- 19 Ag) can be performed using nasopharyngeal or oropharyngeal swab, and nasal swab.
Nasopharyngeal Swab: Insert the sterile swab into the deep nasal cavity until the nasopharynx. Gently rub and rotate the swab against wall of turbinate for several times.
Oropharyngeal Swab: Insert the sterile swab into the deep throat. Gently scrape the secretions around the wall of pharynx and tonsil.
Nasal Swab: Insert the sterile swab into one of the nostrils around 2.5cm. Gently rub against the anterior nasal wall and repeat the actions into the other nostril.
Take out of an assay buffer tube, and tear off the head of the tube. 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. Add the tip onto the assay buffer tube. The assay should be performed immediately in 2 hours after the  specimen preparation. If the assay could not be carried immediately, the prepared specimen should be kept no more than 24 hours at 2-8°C or 7 days at -20°C.
Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly for more than two times. If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening. Remove 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 specimen collection 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.

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.