Clinical application of combined detection of SARS-CoV-2-specific antibody and nucleic acid

Abstract

BACKGROUND The global outbreak of human severe acute respiratory syndrome coronavirus (SARS-CoV)-2 infection represents an urgent need for readily available, accurate and rapid diagnostic tests. Nucleic acid testing of respiratory tract specimens for SARS-CoV-2 is the current gold standard for diagnosis of coronavirus disease 2019 (COVID-19). However, the diagnostic accuracy of reverse transcription polymerase chain reaction (RT-PCR) tests for detecting SARS-CoV-2 nucleic acid may be lower than optimal. The detection of SARS-CoV-2-specific antibodies should be used as a serological non-invasive tool for the diagnosis and management of SARS-CoV-2 infection. AIM To investigate the diagnostic value of SARS-CoV-2 IgM/IgG and nucleic acid detection in COVID-19. METHODS We retrospectively analyzed 652 suspected COVID-19 patients, and 206 non-COVID-19 patients in Wuhan Integrated TCM and Western Medicine Hospital. Data on SARS-CoV-2 nucleic acid tests and serum antibody tests were collected to investigate the diagnostic value of nucleic acid RT-PCR test kits and immunoglobulin (Ig)M/IgG antibody test kits. The χ 2 test was used to compare differences between categorical variables. A 95% confidence interval (CI) was provided by the Wilson score method. All analyses were performed with IBM SPSS Statistics version 22.0 (IBM Corp., Armonk, NY, United States). RESULTS Of the 652 suspected COVID-19 patients, 237 (36.3%) had positive nucleic acid tests, 311 (47.7%) were positive for IgM, and 592 (90.8%) were positive for IgG. There was a significant difference in the positive detection rate between the IgM and IgG test groups ( P < 0.001). Using the RT-PCR results as a reference, the specificity, sensitivity, and accuracy of IgM/IgG combined tests for SARS-CoV-2 infection were 98.5%, 95.8%, and 97.1%, respectively. Of the 415 suspected COVID-19 patients with negative nucleic acid test results, 366 had positive IgM/IgG tests with a positive detection rate of 88.2%. CONCLUSION Our data indicate that serological IgM/IgG antibody combined test had high sensitivity and specificity for the diagnosis of SARS-CoV-2 infection, and can be used in combination with RT-PCR for the diagnosis of SARS-CoV-2 infection.

Automatic system for high-throughput and high-sensitivity diagnosis of SARS-CoV-2

“…Clinically, chest computed tomography (CT) imaging can be used to diagnose COVID-19 [ 3 ]. For large-scale screening, there are two standard logics for SARS‐CoV‐2 diagnostic modalities: testing for the existence of viral particles for current infection status, or using serum antibody tests to indicate the response to infection [ 4 , 5 ]. Recently, there have been reports of people having a different strain of the coronavirus infection than the one that existed several months ago, despite the vaccinated population [ 6 ].…”

A Systematic Review and Meta-Analysis of the Sensitivity of Antibody Tests for the Laboratory Confirmation of COVID-19

“…The overall sensitivity for the IgG, IgM and IgM-IgG LFIA tests (n = 12) ranged from 0.37 (95% CI: 0.27–0.48) [ 60 ] to 0.96 (95% CI: 0.92–0.98) [ 53 , 58 ] and specificity from 0.91 (95% CI: 0.84–0.95) [ 46 ] to 1 (95% CI: 0.98–1) ( Figure 5 ) [ 68 ]. Among the CLIA tests (n = 33), the sensitivity estimates spanned from 0.39 (95% CI: 0.32–0.46) [ 69 ] to 0.97 (95% CI: 0.92–0.99) [ 55 ] and specificity from 0.93 (95% CI: 0.89–0.96) [ 71 ] to 1.00 (95% CI: 0.95–1.00) ( Figure 6 ) [ 61 ].…”

Evaluación de una prueba rápida versus un inmunoanálisis quimioluminiscente de micropartículas para la detección de anticuerpos contra SARS-CoV-2

“…por RT-PCR. [14][15][16] El incremento de los casos generó la necesidad de tener ensayos más rápidos para identificar pacientes positivos, así como asintomáticos, lo cual interrumpirá la cadena epidemiológica al aislarlos de los negativos. 12,13 En este estudio retrospectivo actual, incluimos a 75 pacientes confirmados de COVID-19, para investigar el rendimiento clínico de Vazyme, un ensayo de flujo lateral que detecta cualitativamente anticuerpos IgG/IgM del SARS-CoV-2 utilizando el método de referencia de serología CMIA IgG/IgM (ARCHITECT, Abbott), ya que siempre los comparan con ELISA o RT-PCR.…”

“…12,13 En este estudio retrospectivo actual, incluimos a 75 pacientes confirmados de COVID-19, para investigar el rendimiento clínico de Vazyme, un ensayo de flujo lateral que detecta cualitativamente anticuerpos IgG/IgM del SARS-CoV-2 utilizando el método de referencia de serología CMIA IgG/IgM (ARCHITECT, Abbott), ya que siempre los comparan con ELISA o RT-PCR. 15,16 Los resultados obtenidos en este estudio fueron una sensibilidad de 100% y especificidad de 52% para anticuerpos de clases IgG, demostrando que hay reacción cruzada probablemente con otros antígenos, en cambio para anticuerpos de clases IgM, su sensibilidad fue de 15.6% con una especificidad de 100%, demostrando que tienen bajo rendimiento y moderado para IgG. 17 Todas las muestras se tomaron en un promedio de 34 días después de presentar los síntomas, por lo que deben estar presentes anticuerpos IgM, ya que éstos se mantienen unos meses después.…”