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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