SARS-CoV-2 (COVID-19) Rapid POC Test

The SARS-CoV-2 Total Antibody Rapid POC Test is a single use, rapid device for qualitative detection of total antibodies against 2019 novel coronavirus (SARS-CoV-2) in human serum, plasma or whole blood specimens. The kit is intended for the screening of patients suspected for infection with SARS-CoV-2 and aids the diagnosis of the coronavirus disease 2019 (COVID-19).

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• TGA approved

• Results in 15 minutes

• Suitable for rapid, on-site testing

• Sensitivity of 95.6% (131/137) and specificity of 95.2% (199/209).

• Easy to use. Works with whole blood, serum or plasma samples. 

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Please note: Test kits are approved for clinical use only. Available for purchase by medical practitioners and health professionals. 

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How it works

Test kits are now available for purchase in Australia

HOW IT WORKS

1. Prepare the Test

Allow the test cassette to reach room temperature, use it within 20 minutes after opening the pouch. 

2. Add the Specimen

Add 10μl of whole blood, serum or plasma specimen. Add two drops of Diluent Buffer.

3. Read Result

Results will be ready in 15 minutes.

Please note: In the first few days post infection, there is a false negative rate. People who have symptoms should also do a nucleic acid test or a follow up test 3 days later.

PERFORMANCE DATA

1. Sensitivity and specificity: clinical validation study of the SARS-CoV-2 Ab Rapid Test was conducted in 2020 in Shenzhen, China. 137 specimens from confirmed COVID-19 patients and 209 specimens from healthy individuals were tested. The kit demonstrated the sensitivity of 95.6% (131/137) and the specificity of 95.2% (199/209).

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2. Samples were collected from COVID-19 confirmed cases with clinical symptoms, laboratory abnormalities or pulmonary imaging manifestations. No tests have been performed on specimens from latent infections or patients in the incubation period. It was observed that the detection rate of the kit was closely related to the time of disease onset, the kit showed higher positive detection rate in specimens from patients with delayed onset. Therefore, the interpretation of the test results should consider the specimen's collection time.

Clinical importance of combined RNA and antibody testing

COVID-19 serological markers dynamics (Total Ab/ IgM/ IgG):

• 20%-40% of the patients developed antibodies on days 0-7 after onset

• 60%~70% of the patients developed antibodies on days 8-11 after onset

• > 90% of the patients had detectable levels of antibodies starting from day 12 after onset.

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COVID-19 molecular markers dynamics (RNA):

• RNA was detected in 60-75% of the patients on days 0-8 after onset RNA levels decrease to 40-50% starting from day 9 after onset

• COVID-19 combined serological and molecular markers increases the sensitivity of diagnosis while maintaining the high specificity. Among the serological markers, total Ab detection has greater significance in clinical practice.