Characteristics | Reference test | Index tests | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
WANTAI SARS-CoV-2 Ab ELISA | COVID-19 IgG/IgM Rapid Test: (Whole blood/Serum/Plasma) | COVID-19 BSS (IgG/IgM) | COVID-19 IgG/IgM CASSETTE (Whole blood/Serum/Plasma) | COVID-19 IgG/IgM Rapid Test (Whole blood/Serum/Plasma) | COVID-19 IgG/IgM RAPID TEST DEVICE (WB/S/P) | COVID-19 IgG/IgM Rapid Test (Whole blood/Serum/Plasma) | 2019-nCOV IgG/IgM Rapid test Device | COVID-19 IgG/IgM Rapid Cassette test (Whole blood/Serum/Plasma) | STANDARD Q COVID-19 IgM/IgG Combo | Panbio COVID-19 IgG/IgM RAPID TEST DEVICE | ||
Manufacturer’s name | Beijing Wantai Biological | Sienna TM | Biosynex | ACCU-Tell | InnoScreen™ | SafeCare BioTech | Missing | Hangzhou Realy Tech | Zhejiang Orient Gene Biotech Co.,Ltd | SD Biosensor | Abbott | |
Format | Liquid | Cassette | Cassette | Cassette | Cassette | Cassette | Cassette | Cassette | Cassette | Cassette | Cassette | |
Principle of the test | Antigen “sandwich” enzyme immunoassay | Immunochro matography | Immunochromatography | Immunochromatography | Immunochromatography | Immunochromatography | Immunochromatography | Immunochromatography | Immunochromatography | Immunochromatography | Immunochromatography | |
Antibodies detected | Total Ab | IgM and IgG | IgM and IgG | IgM and IgG | IgM and IgG | IgM and IgG | IgM and IgG | IgM and IgG | IgM and IgG | IgM and IgG | IgM and IgG | |
Product code | WS-1096 | 10,222 A | --- | ABT-IT-B352 | WCOV-23 M | -- | -- | K4602160 | GCCOV-402a | Q-NCOV-01 C QC05020028A | ICO-T402P | |
Lot number | NCOA20210501 | 20,050,504 | COV20040078 | 2,020,032,705 | SR202004013 | NC020032603 | 2,020,025 | N01G16T | 2,004,155 | 2020.06.01 | COV0042014 | |
Samples used | serum/ plasma | Whole blood/serum/ plasma | Whole blood/serum/ plasma | Whole blood/serum/ plasma | Whole blood/serum/ plasma | Whole blood/serum/ plasma | Whole blood/serum/ plasma | Whole blood/serum/ plasma | Whole blood/serum/ plasma | Whole blood/serum/ plasma | Whole blood/serum/ plasma | |
Storage (°C) | + 2–8° | + 2–30° | + 2–30° | + 2–30° | + 2–30° | + 2–30° | + 2–30° | + 2–30° | + 2–30° | + 2–30° | + 2–30° | |
Reading/Interpretation | plate reader, wavelength 450/600 ~ 650 nm | Visual | visual | visual | visual | visual | visual | visual | visual | visual | visual | |
Time to obtain results (min) | 90 | 10 | 10 | 10 | 15 | 10 | 10 | 10 | 2 | 10 | 10 | |
Time to read results (max) | 10 | 20 | 20 | 20 | 20 | 15 | 15 | 15 | 15 | 15 | 20 | |
Composition of the kit | a | c | c | c | c | c | c | c | c | c | c | |
Consumables required but not supplied | b | b | b | b | b | b | b | b | b | b | b | |
Sensitivity according to the manufacturer (%) | 98.72 (> 15 days from onset of symptoms) | 91.76 (IgM) and 88.24 (IgG) | 100 (IgM) and 91.8 (IgG) | 91.8 (IgM) and 100 (IgG) | 93.7 (IgM) and 98.8 (IgG) | Not provided | Not provided | 92 (IgM) and 96 (IgG) | 87.9 (IgM) and 97.2 (IgG) | 94.51 combined sensitivity | 56.25 (IgM) and 95.83 (IgG) | |
Specificity according to the manufacturer (%) | 98.60 | 99.16 (IgM) and 99.46 (IgG) | 99.5 (IgM) and 99.2 (IgG) | 99.2 (IgM) and 99.5 (IgG) | 97.7 (IgM) and 98.7 (IgG) | 100 (IgM) and 100 (IgG) | 100 (IgM) and 100 (IgG) | 95.74 Combined specificity | 94 (IgM) and 100 (IgG) Combined specificity |