The outbreak of the coronavirus disease (COVID‐19), caused by a novel coronavirus called severe acute respiratory syndrome coronavirus (SARS-CoV-2) has led to global health concern. Although the virus nucleic acid real‐time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS‐CoV‐2 infection, these real‐time PCR test kits have many limitations: (1) These tests have long turnaround times and are complicated in operation; they generally take on average over 2 to 3 hours to generate results. (2) The PCR tests require certified laboratories, expensive equipment, and trained technicians to operate. (3) There are some numbers of false negatives for RT‐PCR of COVID‐19 [1, 2]. Therefore, there has been an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients.

Testing of specific antibodies of SARS‐CoV‐2 in patient blood is a good choice for rapid, simple, highly sensitive diagnosis of COVID‐19. It is widely accepted that immunoglobulin M (IgM) provides the first line of defense during viral infections, Before the generation of adaptive, high‐affinity immunoglobulin G (IgG) responses that are important for long term immunity and immunological memory [3, 4]. The rapid detection of both IgM and IgG antibodies will add value to the diagnosis and treatment of COVID‐19 disease. Based on these, AccoBiotech has developed a rapid and simple point‐of‐care lateral flow immunoassay (LFIA) test product, which can detect immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies simultaneously against SARS‐CoV‐2 virus in human blood within 15 minutes.

With this novel COVID‐19 test kit, AccoBiotech has carried out clinical studies to validate the clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from total 130 samples, 30 PCR confirmed COVID‐19 patients and 100 negative patients. The overall testing sensitivity was 90% and specificity was 98%. These novel COVID‐19 test kits can be used in hospitals, clinics, and testing laboratories. The test can also be effectively deployed in businesses, schools, airports, seaports and train stations, etc., giving it the potential to become a compelling force in the fight against this global threat.

References

1. Wang, X., et al., Limits of detection of 6 approved RT–PCR kits for the novel SARS-Coronavirus-2 (SARS-CoV-2). 2020. 66(7): p. 977-979.
2. Park, M., et al., Optimization of primer sets and detection protocols for SARS-CoV-2 of coronavirus disease 2019 (COVID-19) using PCR and real-time PCR. 2020. 52(6): p. 963-977.
3. Racine, R. and G.M.J.I.l. Winslow, IgM in microbial infections: taken for granted? 2009. 125(2): p. 79-85.
4. Li, Z., et al., Development and clinical application of a rapid IgM‐IgG combined antibody test for SARS‐CoV‐2 infection diagnosis. 2020.

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