Table 2.
Representative commercial POCT kits and reported antibody tests for screening of COVID-19.
| Sample volumea | Detection target | Detection method | Sensitivity (True positive rate)b | Specificity (True negative rate)c | Assay detection time | Turn-around time | Commercial products/registration status | Ref. |
|---|---|---|---|---|---|---|---|---|
| / | IgM and IgG | LFIA | / | / | <15 min | <30 min | National Bio Green Sciences, NBGS′ Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid Test Kits; | National Bio Green Sciences LLC (2020) |
| FDA-EUA | ||||||||
| / | IgM and IgG | LFIA (colloidal gold) | / | / | <15 min | <30 min | Cellex, qSARS-CoV-2 IgG/IgM Rapid Test; | Cellex (2020) |
| FDA-EUA | ||||||||
| / | IgG and IgM | LFIA | 99.0% (n = 128) | 99.0% (n = 312) | <15 min | <30 min | Autobio Diagnostics, Anti-SARS-CoV-2 Rapid Test; | Autobio (2020) |
| FDA-EUA | ||||||||
| / | Total antibody against N protein | Electrochemical- luminescence immunoassay | 100% (n = 29) | 99.8% (n = 5272) | ~18 min | <30 min | Roche Diagnostics, Elecsys Anti-SARS-CoV-2; | Roche Ltd (2020b) |
| FDA-EUA | ||||||||
| / | Total antibody against RBD of S1 protein | Chemi-luminescent microparticle immunoassay | 100% (n = 42) | 99.8% (n = 1091) | ~10 min | <20 min | Siemens Healthcare, Atellica IM SARS-CoV-2 Total (COV2T); | Siemens (2020) |
| FDA-EUA | ||||||||
| 10–15 μL | IgM and IgG | LFIA | 88.7% (n = 397) | 90.6% (n = 128) | <15 min | <30 min | Medomics Medical Technologies | Li et al. (2020b) |
| / | IgM and IgG | LFIA | 97.8% (IgM) and 99.6% (IgG) | / | <10 min | <25 min | SureScreen Diagnosis, COVID-19 Coronavirus Rapid Test Cassette | SureScreen Diagnostics (2020) |
| 50 μL | IgM and IgG (recombinant nucleocapsid) | Chemi-luminescence immunoassay | 82.3% (n = 79) | 97.5% (n = 80) | <30 min | <45 min | Tianshen Tech, A chemical immuno-luminescence analyzer ACCRE6 | Lin et al. (2020) |
| 10 μL (serum/plasma), 20 μL (whole blood) |
IgM or IgG | Colloidal gold-based immune-chromatographic (ICG) strip | 11.1% (early stage, 1–7 days after onset), 92.9% (inter-mediate stage, 8–14 days after onset) and 96.8% (late stage, >15 days) (n = 134) | / | <15 min | <30 min | Tested blood sample; in clinical validation stages | Pan et al. (2020) |
| / | Antibodies | Graphene field effect transistor (Gr-FET) | / | / | ~2 min | / | Only tested recombinant spike protein | Zhang et al. (2020b) |
| <1 μl (serum) | Antibody | Immune-precipitation and parallel DNA sequencing | 90–97% | ~97% | At least hours | ~1–2 week | / | Xu et al. (2015) |
Note: IgG (Immunoglobulin G); IgM (Immunoglobulin M); LFIA (lateral flow immunoassay); FDA-EUA (Food and Drug Administration-Emergency Use Authorization).
a
The blood sample is usually in small amount collected from fingertip by “finger-prick”.
b
The sensitivity of a clinical test refers to the ability to correctly identify those patient samples (also called the true positive rate) (Lalkhen and McCluskey, 2008).
c
The specificity of a clinical test refers to the ability to correctly identify those non-patient samples (also called true negative rate) (Lalkhen and McCluskey, 2008).