Table 1.
Serological POC tests and RDT for detection of antibodies against SARS-CoV-2.
| AUTHOR / METHODS USED | SARS-CoV-2 Test |
SENSITIVITY |
SPECIFICITY / ACCURACY | N | ||
|---|---|---|---|---|---|---|
|
Day after symptom onset | ||||||
| 01 – 07 | 08 – 14 | 15 – 39 | ||||
| Yang et al. / Immunochromatography for the qualitative detection of the antibody IgM / IgG to novel Coronavirus (COVID-19) in human whole blood / serum / plasma (USA) | IgM | ND | 82% | ND | 94% / 92% | - |
| IgG | ND | ND | 94% | 97% / 96% | ||
| Abreu et al. / The LFI, SGTi-flex COVID-19 IgM / IgG (Sugentech, Republic of Korea), which is a nanoparticle-based immunochromatographic test kit for the qualitative determination of IgM and IgG COVID-19 antibodies in human whole blood (finger pricked or venous), serum or plasma. | IgM/IgG | ND | 75% | ND | 80,30% / ND | 164 = 27 positives samples and 137 negatives (rt-PCR) |
| Spicuzza et al. / LFA 2019 IgG / IgM Antibody Rapid Test Kit (Beijing Diagreat Biotechnologies Co., Ltd) | IgM/IgG | ND | ND | 83% | 93% / ND | 37 (30 patients admitted to the Infectious Disease Covid 19 or Pneumology Units and 7 healthy controls) |
| Cassaniti et al. / VivaDiag COVID‐19 IgM/IgG Rapid Test lateral flow immunoassay (LFIA) with serum or whole blood sample | IgM/IgG | 18.4% | ND | ND | 91.7% / ND | 50 patients confirmed positive for SARS-CoV-2 by rRT-PCR |
| Li et al. / Lateral flow qualitative immunoassay (LFQI) for the rapid determination of the presence or absence of both anti‐SARS‐CoV‐2‐IgM and anti‐SARS‐CoV‐2‐IgG in human serum, and plasma), manufactured by Jiangsu Medomics Medical Technologies. Specimens (whole blood) | SARS‐CoV‐2 IgG‐IgM combined antibody | 88.66% | ND | ND | 90.63% / ND | A total of 525 cases were tested: 397 (positive) clinically confirmed (including rRT-PCR test) SARS‐CoV‐2‐infected patients and 128 non‐SARS‐CoV‐2‐infected patients (128 negative). |
| Lee et al. / SARS-CoV-2 was detected in a throat swab sample by rRT-PCR. | IgG | 100.0% | 98% / 98.6% | 1 case of COVID-19 confirmed by rRT-PCR | ||
| Lyu et al / LFA (COVI040, GenBody Inc., Cheonan, Republic of Korea) to detect IgM or IgG and ELISA for IgG (RAI010R, BioVendor Laboratories) against SARS-CoV-2 | IgM/IgG | ND | ND | ND | ND / ND | 400 all samples from 2015 - 2017 |
| Capello et al. / VivaDiag ™ COVID-19 IgM / IgG Rapid Test is an in vitro diagnostic test for the qualitative determination of COVID-19 IgM and IgG antibodies | IgM/IgG | ND | ND | ND | ND | 30 (56% men, 44% women; general age 60.9 + 2.71 years; x ± SEM) |
| Pan et al. / Blood samples were collected, and blood serum, plasma or whole blood were subjected to ICG assay in accordance with the manufacturer’s protocol (Zhuhai Livzon Diagnositic Inc.). | IgM | 11.1% | 78.6% | 74.2% | ND | A total of 86 samples from 67 cases of real-time rRT-PCR confirmed SARS-CoV-2 positive |
| IgG | 3.6% | 57.1% | 96.8% | |||
| IgM | 22.2% | 33.3% | 57.1% | ND | Antibody detection in nucleic acid-negative “clinically diagnosed” patients | |
| IgG | 44.4% | 66.7% | 71.4% | |||
| Zhong et al. / ELISA methods for serum samples to detect IgM and IgG antibodies | rN-based IgM | 97.9% | 99.7% / ND | 47 COVID-19 patients ho were nucleic acid-positive (Table S1) and 300 healthy controls were analyzed | ||
| rN-based IgG | 97.9% | 99.7% / ND | ||||
| rS-based IgM | 89.1% | 97.0% / ND | ||||
| rS-based IgG | 95.7% | 85.7% / ND | ||||
| Chemiluminescence methods for serum samples to detect IgM and IgG antibodies | IgM | 97.7% | 95.2% / ND | |||
| IgG | 95.6% | 96.6% / ND | ||||
| Liu et al. / Two Enzyme-Linked Immunosorbent Assay (ELISA) kits based on recombinant SARS-CoV-2 nucleocapsid protein (rN) and spike protein (rS) were used for detecting IgM and IgG antibodies. | rN-based IgM | 68.2% | ND | ND | ND | 214 patients diagnosed with COVID-19. All laboratory confirmed positive for SARS-CoV-2 by rRT-PCR |
| rN-based IgG | 70.1% | ND | ND | ND | ||
| rN-based IgM and-or IgG | 80.4% | ND | ND | ND | ||
| rS-based IgM | 77.1% | ND | ND | ND | ||
| rS-based IgG | 74.3% | ND | ND | ND | ||
| rS-based IgM and-or IgG | 82.2% | ND | ND | ND | ||
| To et al. / Antibody levels against the SARS-CoV-2 internal nucleoprotein (NP) and surface spike protein receptor binding domain (RBD) were measured using EIA (EIA of IgG and IgM against internal viral NP and RBD). | IgM and IgG (EIA) | ND | ND | 108 serum specimens were obtained from 23 patients confirmed positive for SARS-CoV-2 by rRT-PCR | ||
| Zhang et al. / anti-SARSr-CoV IgG and IgM ELISA kits (MaxiSorp Nunc-immuno). | - | Day 0 | Day 5 | Day 15 | ND | 16 patients were viral nucleotide detection positive |
| IgM | ND | 50.0% | 81.0% | ND | ||
| IgG | 81.0% | 100.0% | ND | |||
| Okba et al. / Serologic assays for detection of SARS-CoV-2 neutralizing, spike protein–specific, and nucleocapsid-specific antibodies. Performed anti-SARS-CoV-2 S1 IgG and IgA ELISAs by using β-versions of 2 commercial kits (EUROIMMUN Medizinische Labordiagnostika AG | IgG and IgA (ELISA) | ND | ND | Serum samples (n = 10) collected from 3 patients + serum samples (n = 31) All serum samples from patients with rRT-PCR-confirmed SARS-CoV-2 | ||
| Jin et al. / SARS-CoV-2 IgM and IgG chemiluminescence immunoassay (CLIA). All serum antibody tests were performed by iFlash3000 fully automatic chemiluminescence immunoassay analyzer from Shenzhen YHLO Biotech Co., Ltd (China). | IgM | 48.1% | ND | ND | 100.0% / ND | 27 patients with laboratory confirmed infection and at least one viral serological test (Laboratory confirmation of the virus was based on the result of real time rRT-PCR). |
| IgG | 88.9% | ND | ND | 90.9% / ND | ||
| Zhao et al. / Test for total antibodies, IgM and IgG against SARS-CoV-2 in plasma samples using enzyme linked immunosorbent assay (ELISA) kits supplied Beijing Wantai Biological Pharmacy Enterprise Co., Ltda. | Total antibodies | ND | 89.6% | 100.0% | 99.1% / ND | 173 cases of COVID-19 confirmed by rRT-PCR |
| IgM | ND | 73.3% | 94.3% | 98.6% / ND | ||
| IgG | ND | 54.1% | 78.9% | 99.0% / ND | ||
| RNA by rRT-PCR | ND | 66.7% | 45.5% | ND | ||
| Guo et al. / Western blot and ELISA assays to evaluate the potential cross-reactivities between SARS-CoV-2 and other human coronavirus. | rRT-PCR CONFIRMED CASES | IgM | 75.6% | ND | ND | 208 blood samples from 2 cohorts: 39 patients confirmed positive for SARS-CoV-2; 101 inpatients; 135 plasma samples collected in 2018; 150 plasma samples from healthy adults in 2018-2019 (control); plasma samples positive for human CoV-229E, -NL63, -OC43, -NKU1 and SARS-CoV |
| rRT-PCR NO CONFIRMED CASES IgM |
IgM | 93.1% | ND | ND | ||
| 85.4% | ND | ND | ND | |||
| IgA | 92.7% | ND | ND | ND | ||
| IgG | ND | 77.9% | ND | |||
| rRT-PCR | ND | ND | ||||
| rRT-PCR + Igs |
98.6% | ND | ||||