Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID-19 patients

Abstract

An outbreak of new coronavirus SARS-CoV-2 was occurred in Wuhan, China and rapidly spread to other cities and nations. The standard diagnostic approach that widely adopted in the clinic is nucleic acid detection by real-time RT-PCR. However, the false-negative rate of the technique is unneglectable and serological methods are urgently warranted. Here, we presented the colloidal gold-based immunochromatographic (ICG) strip targeting viral IgM or IgG antibody and compared it with real-time RT-PCR. The sensitivity of ICG assay with IgM and IgG combinatorial detection in nucleic acid confirmed cases were 11.1%, 92.9% and 96.8% at the early stage (1-7 days after onset), intermediate stage (8-14 days after onset), and late stage (more than 15 days), respectively. The ICG detection capacity in nucleic acid-negative suspected cases was 43.6%. In addition, the concordance of whole blood samples and plasma showed Cohen's kappa value of 0.93, which represented the almost perfect agreement between two types of samples. In conclusion, serological ICG strip assay in detecting SARS-CoV-2 infection is both sensitive and consistent, which is considered as an excellent supplementary approach in clinical application.

Ultra-Sensitive High-Resolution Profiling of Anti-SARS-CoV-2 Antibodies for Detecting Early Seroconversion in COVID-19 Patients

“…Many serological enzyme-linked immunosorbent assays (ELISA) have been recently developed to detect anti-SARS-CoV-2 antibodies. However, these assays have four important limitations [4][5][6][7][8][9][10][11][12][13][14][15] . First, they lack the ability to detect antibodies at early stages of infection.…”

Performance verification of detecting COVID-19 specific antibody by using four chemiluminescence immunoassay systems

“…In the occasion of diagnose, both of the sensitivity and specificity should be greater than 95%. In a confirmed diagnostic test, the specificity should be greater than 98% [9]. According to the result of current study, the clinical sensitivity and specificity from all detecting systems does not meet the requirements of screening, diagnosis and confirm diagnosis experiments.…”

“…In current investigation, the average time of serum collection in all subjects at 13 days after diagnosis, therefore it is considered that specific IgM and IgG antibodies should already exist in the specimen. times in recovery period than that of the acute period can confirm diagnosis of COVID-19 [9,10]. The diagnosis standard of COVID-19 changed the situation.…”

<strong>COVID-19 Testing: Challenges, Limitations and Suggestions for Improvement </strong>

“…At the time of this article, these assays were still under development in the United States, with one having just received approval to begin emergency use, but STs have recently been developed and used without prior validation in China (9,24). Initial findings in China have reported a detection accuracy of up to 93% when tests were conducted under the proper conditions (25).…”