Diagnostic efficacy of anti‐SARS‐CoV‐2 IgG/IgM test for COVID‐19: A meta‐analysis

Abstract

The serological testing of anti‐SARS‐CoV‐2 immunoglobulin G (IgG) and/or IgM is widely used in the diagnosis of COVID‐19. However, its diagnostic efficacy remains unclear. In this study, we searched for diagnostic studies from the Web of Science, PubMed, Embase, CNKI, and Wanfang databases to calculate the pooled diagnostic accuracy measures using bivariate random‐effects model meta‐analysis. As a result, 22 from a total of 1613 articles, including 2282 patients with SARS‐CoV‐2 and 1485 healthy persons or patients without SARS‐CoV‐2, were selected for a meta‐analysis. Pooled sensitivity, specificity, and area under curve of the summary receiver operator curve (SROC) were: (a) 0.85 (95% confidence interval [CI]: 0.79‐0.90), 0.99 (95% CI: 0.98‐1.00), and 0.99 (95% CI: 0.97‐0.99) for anti‐SARS‐CoV‐2 IgG and (b) 0.74 (95% CI: 0.65‐0.81), 0.99 (95% CI: 0.97‐1.00), and 0.95 (95% CI: 0.93‐0.97) for IgM. A subgroup analysis among detection methods indicated the sensitivity of IgG and IgM using enzyme‐linked immunosorbent assay were slightly lower than those using gold immunochromatography assay (GICA) and chemiluminescence immunoassay ( P > .05). These results showed that the detection of anti‐SARS‐CoV‐2 IgG and IgM had high diagnostic efficiency to assist the diagnosis of SARS‐CoV‐2 infection. And, GICA might be used as the preferred method for its accuracy and simplicity.

Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold)

“…In these studies, false-positive results were described to be associated with rheumatoid factor-immunoglobulin M (IgM), and urea dissociation was suggested to overcome this problem [ 21 ]. In a meta-analysis, sensitivity of gold immunochromatography assays (GICA) was slightly better than sensitivity of ELISA approaches [ 22 ]. Heat inactivation of sera was described as not relevantly interfering with the reliability of immunochromatographic test assays [ 28 ].…”

Reversible splenial lesion syndrome associated with SARS-CoV-2 infection in two children

“…Both cases were diagnosed with SARS CoV-2 infection based on the detection of anti-SARS-CoV-2 IgG and IgM. Single IgG and IgM tests have been defined as efficient to diagnose SARS CoV-2 infection in the clinical practice [12] . However, it should be stated that the SARS CoV-2 infection was confirmed neither by RT-PCR nor paired serology.…”

Risikostratifizierung von Notfällen während der COVID-19-Pandemie in der Zentralen Notaufnahme

“…Neben den molekularbiologischen Testverfahren stehen mittlerweile auch serologische Verfahren zur Antikörperdiagnostik gegen SARS-CoV‑2 zur Verfügung. Trotz einer hohen Spezifität liegt die Sensitivität dieser Verfahren, u. a. bedingt durch Kreuzreaktivität mit anderen Coronaviren, IgM-Rheumafaktoren, jedoch nur zwischen 70 und 90 % [ 20 , 21 ]. Darüber hinaus sind Antikörpertests gerade in der Frühphase der Infektion nicht zur Detektion der COVID-19-Erkrankung in der Notaufnahme geeignet, da eine Serokonversion in der Regel erst in der zweiten Woche der Infektion zu erwarten ist [ 15 ].…”