The NEWGENE Bioengineering COVID-19 Antigen Detection Kit is suitable for the qualitative detection of novel coronavirus in nasopharyngeal swab or sputum samples. It provides an aid in the diagnosis of infection with novel coronavirus.
The COVID-19 Antigen Detection Kit is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibody against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2. The whole strip is fixed inside a plastic device. When the sample is added into the sample well, conjugates absorbed in the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 antigen is present in the sample, the complex of the anti-SARS-CoV-2 conjugate and the virus will be captured by the specific anti-SARS-CoV-2 monoclonal antibodies coated on the test line region (T). Absence of the T line suggests a negative result. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking effect has occurred.
Checking the contents in the Newgene Covid-19 Detection Kit
Each kit should have the following:
- Test Cassette
- Sample Extraction Tube
- Tube Cap
- Sampling Swab
- Paper Cup
- Sputum Dropper
Newgene Bioengineering Covid Test Usage Instruction
- Have the patient take a deep breath, and expectorate deep cough sputum into the paper cup or a sputum container. Note: If the patient has eaten or drunk just before sample collection, rinse the mouth with clean water.
- Use the sputum dropper to transfer 0.6 mL of the sputum sample into sample extraction tube. The dropper draws up 0.3 mL sample at a time. Perform the sample transfer procedure twice.
- Peel off the aluminum foil seal from a sample extraction tube
- Transfer 0.6 mL sputum sample into sample extraction tube. Note: Sputum is highly viscous. Please strictly follow the instructions described above. Adding excessive or insufficient sputum sample may cause inaccurate results.
- Squeeze the dropper 5 times to mix the sputum sample with sample extraction solution.
- Insert the tube cap firmly on the sample extraction tube. Put the tube still for 1 minute to release viral antigens.
- Flick the bottom of the tube to mix sample solution.
- Take out a test card from an aluminum foil pouch. Place the test card on a table. Hold the tube upside down vertically. Squeeze the tube to expel 3 drops of sample solution into the loading well on a test card.
- Read the result at 15 to 30 minutes. The result is considered inaccurate and invalid after 30 minutes. Note: DO NOT reload sample solution to the loading well of a used test card.
How to Interpret the result of the Newgene Saliva Test Kit
POSITIVE (+): Red bands appear both at T and C line in 15 to 30 minutes. A White band at T line should be considered as a negative result. Please update your mySejahtera profile status and head over to a hospital / clinic nearby to get a PCR test immediately. Suggest to also get your close contact screened using the home test kit as well.
NEGATIVE (-): A red band appears at C line while no red band appears at T line in 15-30 minutes after sample loading.
INVALID: As long as no red band appears at C line, it indicates that the test result is invalid and should retest the sample with another new kit. There are multiple reasons including insufficient samples of saliva, mixed up of procedure, too quick to test/waited too long to drip the mixed reagent into the test kit, or it could also be a faulty test kit. Please try another kit following the exact guide again.
*Information taken from NEWGENE Bioengineering Website