Table 3.
List of a few currently available diagnostic assays for the detection of COVID-19 across the globe.
| Method/Test name/ Manufacturer/ Organization name | Sample collection | Target/Gene | Sensitivity | Specificity | Processing time | Cost | Site of use | References |
|---|---|---|---|---|---|---|---|---|
| 1) RT-PCR | (i) Nasopharyngeal swab (ii) Sputum (iii) Stool (iv) Tracheal aspirate (iv) Brachial aspirate (v) BAL (vi) BAL (vii) Human EDTA plasma (viii) Oropharyngeal swabs |
(i) ORF1ab/RdRp (RNA dependent RNA polymerase) (ii) Envelope protein (E) (iii) Nucleocapsid (N) (iv) Spike (S) protein |
69–100 % | 77–90 % | 1–4 h | H | T | (Tahamtan and Ardebili, 2020) |
| 1.1) Xpert® Xpress SARS-CoV-2 | (i) Nasopharyngeal (ii) Oropharyngeal (iii) Nasal wash/aspirate |
E & N2 | 95 | NA | 2 h | H | T | (Loeffelholz et al., 2020; Wolters et al., 2020) |
| 1.2) LabGun COVID-19 Assay plus | (i) Nasopharyngeal (ii) Oropharyngeal (iii)Nasal aspirate (iv) Sputum |
E & RdRp | 95 | 1.8 × 103 NDU/m | 3–4 h | H | T | (LabGenomics, 2020) |
| 1.3) Pathodetect Coronavirus (COVID-19) Qualitative PCR Kit | (i) BAL nasopharyngeal (ii) Sputum (iii) Serum (iv) Tissue |
E & RdRp | 100 | 100 | 3–30 h | H | T | (mylabdiscovery, 2020) |
| 1.4) STANDARD M nCoV Real-Time Detection kit | (i) Nasopharyngeal (ii) Oropharyngeal (iii) Midturbinate nasal swab (iv) Sputum specimens |
E & RdRp | 95 | NA | 1.5–2 h | H | T | (SDBiosensor, 2020) |
| 1.5) QuantiTect Virus +Rox Vial kit (QIAGEN, Hilden, Germany) | (i) Nasopharyngeal swabs (NPS) (ii) Sputum |
E & RdRp | 0.97 | 0.92 | 2–3 h | H | T | (Böhmer et al., 2020) |
| 1.6) Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (BGIGenomics Co. Lt) | (i) Oropharyngeal swabs (ii) BALF |
ORF1ab | 69.1–89.1% | 77.0–97.0% | 1–2 h | H | T | (Afzal, 2020) |
| 2) LAMP | (i) Nasopharyngeal swab (ii) Sputum (iii) Stool (iv) Respiratory secretions (v) Plasma (vi) Serum |
(i) ORF1ab/N (ii) RNA of SARS CoV-2 (iii) IgG/IgM |
52–100% | 43–100% | 5–35 min | L/M | T | (El-Tholoth et al., 2020) |
| 2.1) Loopamp®2019-SARS-CoV-2 Detection Reagent Kit | Nasopharyngeal swab | RNA of a SARS-CoV-2 | 100% | 97.60% | 35 min | M | T | (Kitagawa et al., 2020) |
| 2.2) Abbott ID NOW COVID-19 test (Abbott 125Diagnostics, Lake Forest, IL) | (i) Plasma (ii) Serum |
IgM/IgG | 52–97% | 43–99.62% | 5–13 min | L | T | (Shah, July 13, 2020) |
| 2.3) COVID-19 Rapid Isothermal PCR Kit | Nasopharyngeal swabs | Nucleocapsid (N) protein | 25 viral RNA copies / µl | NA | 30 min | M | T | (Raybiotech, 2020) |
| 3) Immunoassays | (i) Serum (ii) Plasma (iii) Whole Blood |
Antibody detection | 58–81% (IgM) 53–98% (IgG) 80–99% (IgM+IgG) |
83.1–100% | 10 min–3 h | M | T | (Jääskeläinen et al., 2020) |
| 3.1) Maglumi™2019-n-Cov IgG and IgM | (i) Serum (ii) Plasma (iii) Whole Blood |
IgM and IgG against viral recombinant antigen | IgM (58.7%) 53.2% (IgG) 64.30% (IgA/IgG) |
94.9–100 % (IgM) 94.9–100% (IgG) 94.9–100 % (IgA/IgG) |
30 min | M | T | (Montesinos et al., 2020) |
| 3.2) EuroimmunAnti-SARS-CoV-2 IgG and IgA assay | Serum | IgG and IgA against S1 structural protein | 83.6% (IgA) 61.7% (IgG) 84.40% (IgA+IgG) |
83.1% (IgA) 98.6% (IgG) 87.50% (IgA+IgG) |
3 h | M | T | (Nicol et al., 2020) |
| 3.3) Atellica IM SARS-CoV-2 Total (COV2T), Chemiluminescent microparticle immunoassay, Siemens Healthcare | (i) Serum (ii) Plasma |
Total antibody against RBD of S1 protein | 14 days post-symptom onset:100% | 14 days post-symptom onset:99.8% | ~10 min | M | T | (Smithgall et al., 2020) |
| 3.4) Abbott ARCHITECT i2000SR |
(i) Serum (ii) Plasma |
IgG against nucleocapsida protein (NCP) | 97–100% | 100% | 2–3 h | M | T | (Nicol et al., 2020) |
| 3.5) Covid Kavach Elisa, Indian Council for Medical Research (ICMR) | Blood | IgG-based ELISA | 92.37% | 97.90% | 2–3 h | M | T | (Sapkal et al., 2020) |
| 3.6) LIAISON® SARS-CoV-2 IgM & IgG, DiaSorin assays | Serum | IgM and IgG against S1/S2 protein | ≤7 days: 69.5% (60.2–77.5%) 8–14 days: 91.5% (80.1–96.6%) 15–30 days: 98.3% (93.9–99.5%) |
99.20% | 2–3 h | M | T | (Bonelli et al., 2020) |
| 3.7) Roche’s SARS-CoV-2 antibody test, Roche Diagnostics | Blood | IgM and IgG | 87.0% | 100% | 18 min | M | T | (Burki, 2020) |
| 4) Lateral Flow | (i) Blood (ii) Serum (iii) Plasma |
Antibody detection | 48–84% | 31–100% | 5–20 min | L/M | P | (Wu et al., 2020b) |
| 4.1) COVID-19 IgG/IgM Rapid Test Cassette (Premier Biotech, Minneapolis, MN) | (i) Whole blood (ii) Serum (iii) Plasma |
IgG/IgM | 82.80% | 99.50% | 12–20 min | M | P | (Dobaño et al., 2020) |
| 4.2) STANDARD Q COVID-11619 IgM/IgG Duo Test kits (SD Biosensor, Gyeonggi-do, Korea) | (i) Whole blood (ii) Serum (iii) Plasma |
IgM/IgG | 11% in early infection and up to 100% beyond 14 days of infection | 43–85.7% | 15 min | L | P | (PIH, 2020) |
| 4.3) COVID-19 Ag Respi Strip | Oropharyngeal swab in VTM | SARS-CoV-2 antigen | 30.20% | 100% | 15 min | L | P | (Scohy et al., 2020) |
| 4.4) BIOCARD Pro COVID-19 Rapid Ag test kit | Human Nasopharyngeal Swab | Covid 19 Antigen | 83% | 98% | 5–7 min | L | P | (Trivitron, 2020) |
| 4.5) Feluda paper strip test | Nasopharyngeal | SARS-CoV-2 antigen | 96% | 98% | 45 min | L | P | (ICMR, 2020a) |
#H, High; M, Medium; L, Low; P, Primary Care; T, Tertiary Care.