Highlighted Prospects of an IgM/IgG Antibodies Test in Identifying Individuals With Asymptomatic Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection.

Covert severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections could be seeding new outbreaks. How to identify asymptomatic SARS-CoV-2 infections early has become a global focus. To explore the roles of immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies detection, nucleic acid tests, and computed tomography (CT) scanning to identify asymptomatic SARS-CoV-2 infection. The clinical data of 389 individuals with close contacts, including in general characteristics, SARS-CoV-2 etiology, serum-specific IgM and IgG antibody detection and CT imaging results, were systematically analyzed. The present study showed that only 89 of 389 individuals with close contacts were positive after the first nucleic acid test, while 300 individuals were still negative after 2 nucleic acid tests. Among the 300 individuals, 75 did not have pneumonia, and the other 225 individuals had pulmonary imaging changes. A total of 143 individuals were eventually diagnosed as having asymptomatic infection through IgM antibody and IgG antibody detection. The sensitivity, specificity, and false-negative rate of IgM and IgG antibody detection were approximately 97.1% (347 of 357), 95.3% (204 of 214), and 4.67% (10 of 214), respectively. It also indicated that during approximately 2 weeks, most individuals were both IgM positive and IgG positive, accounting for 68.57% (72 of 105). During approximately 3 weeks, the proportion of IgM-positive and IgG-positive individuals decreased to 8.57% (9 of 105), and the proportion of IgM-negative and IgG-positive individuals increased to 76.19% (80 of 105). There are highlighted prospects of IgM/IgG antibody detection as a preferred method in identifying the individuals with asymptomatic SARS-CoV-2 infection, especially combined with nucleic acid tests and pulmonary CT scanning.

Li Y ，He Q ，Yu R ，Jiang H ，Wang W ，Feng D ，Hou G ，Zhou H ，Jiang Y ，Xiang Z ... -  《-》

Analysis of Nucleic Acid and Antibody Detection Results for SARS-CoV-2 Infection.

Real-time polymerase chain reaction (RT-PCR) of virus nucleic acid test (NAT) has become the standard method to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. However, there are still many limitations, especially the problem of the high false negative rate. Therefore, the aim of this study was to investigate the positive rate of SARS-CoV-2 NAT and evaluate the diagnostic performance of SARS-CoV-2 IgM and IgG antibody detection in novel coronavirus infection. A total of 10309 suspected or high-risk cases of infection with SARS-CoV-2 in Wuhan Hubei, China, were tested for virus NAT by RT-PCR. Among those cases, 762 COVID-19 patients and 143 patients with non-COVID-19 who were tested for SARS-CoV-2 IgM and IgG during the NAT period were screened. The difference between the two test methods was analyzed using the chi-square test. The positive rate of 10309 cases was about 36% (95% CI: 33.39%-39.67%). SARS-CoV-2 was present in various types of specimens, and alveolar lavage fluid had the highest positive rate [52.38% (95% CI: 31.02-73.74)]. The clinical sensitivity of serum SARS-CoV-2 IgM and IgG was 77.17% (588/762) and 94.88% (723/762), respectively, and the clinical specificity was 93.71% (134/143) and 90.21% (129/143). The area under the curve (AUC) of SARS-CoV-2 IgG and combination of IgG with IgM were equally larger than IgM [0.973 (95% CI: 0.964-0.983) vs 0.930 (95% CI: 0.910-0.949)]. IgG antibody had the highest specificity [100.0% (95% CI: 100.00%-100.00%)] and sensitivity [94.0% (95% CI: 92.45%-95.55%)] when detected alone or in combination with IgM antibody. The total coincidence rate of SARS-CoV-2 antibodies detection and SARS-CoV-2 NAT for the diagnosis of SARS-CoV-2 infection was 92.04% (833/905). Among the 34 SARS-CoV-2 NAT-negative patients with clinical symptoms and CT imaging features, 29 (85.29%) patients were positive for SARS-CoV-2 IgM, and 31 (91.76%) were positive for IgG. SARS-CoV-2 NAT should be considered for many types of specimens, and the combined test of SARS-CoV-2 IgM and IgG can make up for the problem of missed NAT in COVID-19 patients.

Chen J ，Niu Z ，Li H ，Tang D ，Zhang P ... -  《-》

Dynamic Changes of Antibodies to SARS-CoV-2 in COVID-19 Patients at Early Stage of Outbreak.

Shu H ，Wang S ，Ruan S ，Wang Y ，Zhang J ，Yuan Y ，Liu H ，Wu Y ，Li R ，Pan S ，Ouyang Y ，Yuan S ，Zhou P ，Shang Y ... -  《-》

Evaluation of serum IgM and IgG antibodies in COVID-19 patients by enzyme linked immunosorbent assay.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is sweeping the world since the end of 2019. The titer change of antibodies against SARS-CoV-2 needs to be further clarified, the clinical and preventive value of antibodies still needs to be further investigated. An enzyme-linked immunosorbent assay (ELISA) was established by coating with SARS-CoV-2 recombinant spike protein and used to detect serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against SARS-CoV-2 in coronavirus disease 2019 patients to evaluate the pattern of changes of antibodies. The specificity of the ELISA for detection SARS-CoV-2 IgM and IgG were 96% (144/150) and 100% (150/150), respectively. The sensitivity of ELISA was 100% (150/150) for IgM, and 99.3% (149/150) for IgG. SARS-CoV-2-SP-IgM and SP-IgG antibodies could be detected on Day 1 of hospitalization in 12.5% patients, and SP-IgM began to decrease after reaching its peak at around 22-28 days, and become negative at Month 3 in 30% patients and negative at Month 7 in 79% of these patients after onset; IgG reached its peak around Day 22-28 and kept at a high level within the longest observation period for 4 months, it dropped very sharply at 7 months. The positive rates of SP-IgM and SP-IgG were higher than those of reverse transcription-polymerase chain reaction on Day 7 and 4. The established indirect ELISA has good specificity and sensitivity. IgM and IgG against SARS-CoV-2 appeared almost simultaneously in the early stage, and the level of IgG antibodies could not maintain a high plateau in the observation period of 7 months. Our data will help develop the diagnosis and vaccine of SARS-CoV-2.

Zhou C ，Bu G ，Sun Y ，Ren C ，Qu M ，Gao Y ，Zhu Y ，Wang L ，Sun L ，Liu Y ... -  《-》

Detection of SARS-CoV-2-specific antibodies via rapid diagnostic immunoassays in COVID-19 patients.

Chansaenroj J ，Yorsaeng R ，Posuwan N ，Puenpa J ，Sudhinaraset N ，Chirathaworn C ，Poovorawan Y ... -  《Virology Journal》