Can colloidal Gold Immunochromatography Assay test be alternative to RT-PCR test for diagnosis of COVID-19?


The current standard laboratory test for COVID-19 diagnosis is RT-PCR which identifies the viral genomic RNA has several disadvantages being time-consuming, expensive and high requirements of laboratory. A meta-analysis study by Zhang Z.L et al (2020) and Lisboa Bastos M et al (2020) reveals the diagnostic efficacy of RT-PCR test remains unclear. This leads to search of urgently identifying tests with better diagnostic accuracy. 

Gold Immunochromatography assay (GICA) might be used as preferred method for obtaining accuracy and efficacy. GICA test has following advantages that it can be widely used (blood, serum and plasma can be detected); fast detection (10-15 minutes for whole process); simple operation (no professional technical personnel required for the equipment); low cost and easy to use.

Through the study conducted by Shen B et al (2020); found that IgM/IgG test demonstrated high sensitivity 71.1% and specificity 96.2% in 150 suspect COVID-19 cases taking RT-PCR result as reference standard. Another insight from the study is sensitivity of antibody assays and antibody density both increased along with the course of disease. The sensitivity for patients within 7 days from the onset of symptoms was 55% and for patients within 14 days after the onset of symptoms was 95.8%.

Seroconversion time (time period during which a specific antibody develops and becomes detectable in the blood) and antibody density may also serve as prognostic factor of COVID-19. Therefore, the colloidal GICA test for COVID-19 IgG/IgM detection had high sensitivity and specificity. It provided a accurate diagnostic method that can be used as a triage test before the nucleic acid analysis in several important COVID-19 infection control.

Reference:

1.  Zhang ZL, Hou YL, Li DT, Li FZ. Diagnostic efficacy of anti-SARS-CoV-2 IgG/IgM test for Covid-19: A meta-analysis [published online ahead of print, 2020 Jun 22]. J Med Virol. 2020;10.1002/jmv.26211. doi:10.1002/jmv.26211.

2.  Lisboa Bastos M, Tavaziva G, Abidi SK, et al. Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis. BMJ. 2020;370:m2516. Published 2020 Jul 1. doi:10.1136/bmj.m2516.

3. Shen B, Zheng Y, Zhang X, et al. Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG. Am J Transl Res. 2020;12(4):1348-1354. Published 2020 Apr 15.



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