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).

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.

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.

Frequently asked questions

How does the SARS-CoV-2 Antibody Rapid Test work?


The SARS-CoV-2 Ab Rapid Test employs chromatographic lateral flow device in a cassette format. Colloidal gold conjugated recombinant antigens corresponding to SARS-CoV-2 are dry-immobilized at the end of nitrocellulose membrane strip. SARS-CoV-2 antigens are bound at the Test Zone {T) and antibodies are bound at the Control Zone {C). When the specimen is added, it migrates by capillary diffusion rehydrating the gold conjugate. If present in specimen, SARS-CoV-2 antibody will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone {T) where they are captured by the SARS-CoV-2 antibody generating a visible red line. If there is no SARS-CoV-2 antibody in specimen, no red line is formed in the Test Zone {T). The gold conjugate will continue to migrate alone until it is captured in the Control Zone {C) by the antibodies aggregating in a red line, which indicates the validity of the test.




What samples can I use?


Human serum, plasma or whole blood specimens can be used for the SARS-CoV-2 antibody rapid test. Plasma or whole blood specimens containing EDTA, sodium citrate or heparin can be used for this test. Whole blood specimens can be venous whole blood or fingertip blood. Specimens containing suspended fibrin or aggregates and severe hemolysis {hemoglobin content greater than 400mg/ L) cannot be detected, but jaundice {bilirubin content less than l.71mmol/L) and hyperlipemia {triglyceride content less than 170mmol/L) can be detected.




How should I store the SARS-CoV-2 Ab Rapid Tests?


The recommended storage temperature is 2 – 30°C for 12 months from the date of manufacture. Do not freeze.




How accurate is the SARS-CoV-2 Antibody Rapid Test?


Clinical validation study of the SARS-CoV-2 Antibody Rapid Test was conducted in 2020 in Beijing, Zhejiang and Yunnan in China. 132 specimens from confirmed COVID-19 cases and 271 specimens from the excluded COVID-19 cases and healthy individuals were tested. The kit demonstrated the following results: Sensitivity of 94.70% (125/132) Specificity of 98.89% (268/271) Overall agreement of 97.52% This clinical study is evidence of the usability, accuracy and effectiveness of the test.




Is the SARS-CoV-2 Antibody Rapid Test CE marked?


The test is CE marked for professional use and is a registered In Vitro Diagnostic (IVD) medical device.




Has the SARS-CoV-2 Antibody Rapid Test been accredited?


The test is CE marked for professional use and is therefore suitable and ready for use by healthcare professionals. In addition to our clinical evaluations already completed on the product, we are currently working with a number of independent laboratories and Departments of Health to further validate the product and gain best practice approvals.




Can the SARS-CoV-2 Antibody Rapid Test detect asymptomatic patients?


Yes, the test will be able to detect IgM/IgG in asymptomatic people, as they will have an immune response even though they don’t display symptoms. The timeline of infection will be the same as someone displaying symptoms.





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