Table 1.
(A) Oligonucleotide based molecular detection: | |||||||||
Sr. No |
Developer |
Commercial Brand Name |
Analytical Method |
Technical Details |
Detection Time |
Clinical Sample |
Status |
Limit of Detection / Detection Ability |
Source |
1 | 1 copy™ | 1 copy™ COVID-19 qPCR Kit | RT-qPCR | Qualitative detection of E gene and RdRP gene of COVID-19 with RT-qPCR via RNA extracted from a specimen of an infected patient | 1 h 50 min | Nasopharyngeal swab, Oropharyngeal swab, Sputum | CE-IVD | 4 copies / reaction | http://www.1drop.co.kr/ |
2 | Abbott Molecular Inc. | Abbott RealTime SARS-CoV-2 | RT-PCR | The Abbott RT- SARS-CoV-2 assay is a dual target assay assess for the RdRp and N genes | NR | Nasopharyngeal and oropharyngeal swabs | USA CE-IVD | 1-4 X 102 copies/mL | https://www.molecular.abbott/us/en/products/infectious-disease/RealTime-SARS-CoV-2-Assay |
3 | AB ANALITICA | REALQUALITY RQ-2019-nCoV | One-step RT-PCR |
Includes RT-PCR amplification targets to the RdRP gene, E gene and the internal control for qualitative analyses. | 1 h 40 min | Nasopharyngeal swabs, sputum and bronchoalveolar lavage |
Manual; lab-based NAT; CE-IVD |
NR | https://www.abanalitica.com/en/catalogo/product/realquality-rq-2019-ncov/ |
4 | A*ccelerate Technology Pte Ltd | A*STAR Fortitude Kit 2.0 | One-step RT-PCR | Runs on the RT-PCR laboratory technique that detects SARS-CoV-2 virus genetic material (E gene and RdRP gene) | 1 h 30 min | Human Clinical Samples | Singapore HSA | 25 copies / reaction | https://www.a-star.edu.sg/News-and-Events/a-star-news/covid-19/news/covid-19/fighting-covid-19-with-fortitude |
5 | ADT Biotech | LyteStar 2019-nCoV RT-PCR Kit 1.0 | RT-PCR | Dual target kit for screening and confirmation of SARS-related CoV E-gene and 2019-nCoV specific RdRP-gene | NR | Fresh or frozen human serum and plasma, respiratory specimens, and stool | RUO | NR | https://www.dropbox.com/s/2j8uix6d5dwsvr0/LyteStar%202019-nCoV_Flyer.pdf?dl=0 |
6 | Altona Diagnostics | RealStar® SARS-CoV-2 RT-PCR Kit | RT- PCR | Detection and differentiation of lineage ß-betacoronavirus (β-ßCoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA | NR | Human Clinical Samples | RUO | NR | https://altona-diagnostics.com/en/products/reagents-140/reagents/realstar-real-time-pcr-reagents/realstar-sars-cov-2-rt-pcr-kit-ruo.html |
7 | Beijing Applied Biological Technologies Co., Ltd. | Multiple RT- PCR Kit for Detection of 2019-nCoV | RT- fluorescent PCR detection | Detection kit, screening the specific genes: ORF1ab, N and E gene | 1 h 50 min | Human Clinical Samples | China FDA–EUA; CE-IVD | 1 × 103 copies / mL | http://www.x-abt.com/index.php?m=content&c=index&a=lists&catid=144 |
8 | BGI Health (HK) Co. Ltd. | RT- fluorescent RT-PCR kit for detecting 2019 nCoV | RT- Fluorescent RT-PCR kit | No cross-reactivity with the human genome and other pathogens including 54 pathogens, such as human coronavirus OC43, 229E, HKU1 and NL63(HCoV-OC43, HCoV-229E, HCoV-HKU1, HCoV-NL63), etc | 3 h | Throat swab and Bronchoalveolar Lavage Fluid(BALF) samples | China-FDA EUA | 100 copies / mL | https://www.bgi.com/global/molecular-genetics/2019-ncov-detection-kit/ |
9 | Caspr Biotech | Phantom 1.0 Dx | Ultrasensitive, rapid, and portable coronavirus SARS-CoV-2 sequence detection | Based on CRISPR-Cas12, Point of Care approach |
> 1 h | Human clinical sample | USA, Validated | 103 copies / mL | https://www.biorxiv.org/content/10.1101/2020.02.29.971127v1.full.pdf |
10 | Cancer Rop Co., Ltd. | Q-Sens® 2019-nCoV Detection Kit | RT-PCR based | Detection and amplification of nucleotide sequence of the genes specific to SARS-CoV-2 | 2 h | Sputum, nasopharyngeal smear, and bronchial alveolar lavage fluid | CE-IVD | NR | http://www.cancerrop.com/news_notices/news?tpf=board/view&board_code=6&code=311 |
11 | Liming Bio-Products Co., Ltd. | SrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex RT- PCR Kit | Fluorescent probe-based Taqman® RT-qPCR | Designed for the detection of a conserved region of SARS-CoV-2’s ORF1ab gene, E gene, and N gene, avoiding non-specific interference of SARS2003 and Bat-SARS-like virus strains | NR | Human Clinical Samples | CE-IVD | NR | http://www.limingbio.com/index.php?m=content&c=index&a=show&catid=18&id=113 |
11 | Novacyt/Primerdesign Ltd. | Genesig RT- PCR COVID-19 | RT- PCR | Rapid detection and exclusive to the COVID-19 strain, high priming efficiency with accurate controls to confirm extraction, and assay validity | NR | Clinical Samples | US-FDA EUA; CE-IVD | NR | https://www.genesig.com/products/10039-coronavirus-covid-19-ce-ivd |
12 | PerkinElmer Inc. | PerkinElmer® SARS-CoV-2 RT-PCR Assay | RT-PCR | Detects SARS-CoV-2 ORF1ab and N genes | NR | Human oropharyngeal and nasopharyngeal swab samples | CE-IVD | 20 copies / mL | https://perkinelmer-appliedgenomics.com/home/products/new-coronavirus-2019-ncov-nucleic-acid-detection-kit/ |
13 | Pishtaz Teb | COVID-19 Onestep RT-PCR Dual Target Gene | One-Step RT-PCR | The primer probe of this kit adopts the dual-target gene design, which targets the specific conserved sequence encoding the RdRp region and the N region. | 1 h 30 min | Bronchoalveolar lavage fluid, sputum, throat and nasal swab | Iran-FDA | NR | http://assets.pishtazteb.com/uploads/1970806048.covid19-EN-min.pdf |
14 | SD BIOSENSOR Inc. | STANDARD M nCoV RT- Detection Kit | One Step RT-PCR | Designed according to WHO interim guidance includes 2019-nCov detects nCoV associated ORF1ab gene, E gene and provides Internal Control | 1 h 30 min | Nasopharyngeal swab, Oropharyngeal swab, Sputum | (Korea-EUA; CE-IVD | NR | http://sdbiosensor.com/xe/product/7653 |
15 | Sherlock Biosciences, Cepheid | SHERLOCK™ (Specific High Sensitivity Enzymatic Reporter unlocking) | Rapid CRISPR-based tests for SARS-CoV-2 and other pathogens | Combines SHERLOCK Cas12 and Cas13 enzymes for nucleic acid detection with Cepheid’s GeneXpert test-processing instruments | NR | Genetic material obtained from human clinical samples | US-FDA EUA | NR | https://www.prnewswire.com/news-releases/cepheid-and-sherlock-biosciences-establish-collaboration-on-new-genexpert-tests-for-infectious-diseases-and-oncology-leveraging-crispr-technology-301013198.html |
16 | Thermo Fisher Scientific | TaqManTM SARS-CoV-2 Assay Kit v2 | RT-PCR | 2019-nCoV Assay (Orf1 ab); 2019-nCoV Assay (spike (S) gene); 2019-nCoV Assay (nucleocapsid (N) gene); Rnase P (control) | NR | Human Clinical Samples | US-FDA EUA | NR | https://www.thermofisher.com/jp/ja/home/clinical/clinical-genomics/pathogen-detection-solutions/coronavirus-2019-ncov/genetic-analysis.html#TaqMan-2019-nCoV-Assay-Kit |
17 | US CDC | 2019 nCoV RT-PCR Diagnostic Panel | RT-PCR based | The nCoVPC contains non-infectious positive control material supplied in a dried state. nCoVPC consists of in vitro transcribed RNA. nCoVPC will yield a positive result with each assay in the systems diagnostic Panel including RP. | 1 h 20 min | Human sera or pooled leftover negative respiratory specimens | US-FDA EUA | 102.5 Copies / mL | https://www.genscript.com/2019-ncov-qrt-pcr-detection-assay.html?src=topbanner |
18 | Wuhan Easydiagnosis Biomedicine Co., Ltd | SARS-CoV-2 nucleic acid test kit | Fluorescent RT-PCR based | Used to qualitatively detect the new coronavirus 2019-nCoV infection in suspects by analysing ORF1ab gene and N gene | NR | Oropharyngeal swabs, nasopharyngeal swabs and sputum samples from patients diagnosed or differentiated | China-FDA EUA; CE-IVD | NR | http://www.mdeasydiagnosis.com/products/InternationalTrade/88.html |
19 | Xiamen Zeesan Biotech Co., Ltd. | SARS-CoV-2 Test Kit | RT-PCR based | In vitro qualitative detection of novel coronavirus (SARS-CoV-2) ORF1ab and N gene in samples | NR | Sample includes bronchoalveolar lavage fluid and sputum, and stool sample can be anal swab. |
Manual; lab-based; CE-IVD |
NR | http://www.zeesandx.com/products/sars-cov-2-test-kit-real-time-pcr.html |
(B) Point-of-Care Immunodiagnostics: | |||||||||
Sr. No |
Developer |
Commercial Brand Name |
Analytical Method |
Technical Details |
Detection Time |
Clinical Sample |
Status |
Limit of Detection / Detection Ability |
Links |
1 | BioMedomics, Inc. | COVID-19 IgM-IgG Dual Antibody Rapid Test | Qualitatively detect IgG and IgM antibodies | This test detects both early and late marker, of corona virus associated IgM/IgG antibodies in human | 10-15 min / test | Whole blood, serum, or plasma | EU (CE Mark), USA (EUA) | NR | https://www.biomedomics.com/products/infectious-disease/covid-19-rt/ |
2 | Bioscience (Chongqing) Biotechnology Co., Ltd. | Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit Novel Coronavirus (2019-nCoV) IgG Antibody Test Kit |
Chemiluminescent immunoassay technology | Identifies IgM/IgG antibodies using magnetic particle chemiluminescence method |
NR | Human clinical blood samples | China (EUA) | NR | https://www.medica-tradefair.com/vis/v1/en/exhibitors/medcom2019.2643477 |
3 | Biomerica | 10 Minute Test for COVID-19 Virus | Rapid POC IgM/IgG antibody test | Lateral flow immunoassay | 10 min | Whole blood, sera or plasma | Commenced shipping samples; seeking FDA EUA approval | NR | http://biomerica.com/news/news_view.asp?NewsItem=249 |
4 | Guangzhou Wondfo Biotech (Guangzhou, China) | Finecare SARS-CoV-2 Antibody Test | Antibody test | Lateral flow immunoassay that detects IgM and IgG antibodies directed against SARS-CoV-2 | 15 min | Serum or Plasma sample | National Medical Products Administration EUA in China; CE mark in Europe | NR | https://en.wondfo.com.cn/covid-19-3/ |
5 | Innovita Biological Technology | 2019-nCoV Ab Test (Colloidal Gold) | IgM/IgG combine detection | Lateral flow immunoassay that detects IgM and IgG antibodies directed against SARS-CoV-2 | 10 min | Human serum, Plasma, venous whole blood | China-FDA EUA; CE-IVD | NR | http://www.innovita.com.cn/index.html |
6 | InTec PRODUCTS, INC. | Rapid SARS-CoV-2 Antibody (IgM/IgG) Test | IgM and IgG antibody detection | Rapid immunoassay for the qualitative detection of IgM and IgG antibodies | NR | Single drop of fingerpick whole blood | EU, CE-IVD | NR | https://www.intecasi.com/news/156-intec-products-rapid-sars-cov-2-antibody-test-is-now-available |
7 | Snibe Diagnostic | MAGLUMI 2019-nCoV IgM/IgG (CLIA) | MAGLUMI 2019-nCoV IgM/IgG kit | Automated central laboratory rapid test that runs on MAGLUMI chemiluminescence immunoassay system | 30 min | Blood sample | automated IA, CE-IVD | NR | http://www.snibe.com/zh_en/en_newsView.aspx?id=576 |
8 | Sugentech | COVID-19 IgM/IgG | SGTi-flex COVID-19 IgM/IgG | Lateral flow immunoassay that detects IgM and IgG antibodies directed against SARS-CoV-2 | 10 min | Human whole blood (finger prick or venous), serum or plasma | CE-IVD | NR | http://sugentech.com/products/products-view.php?ct=7&target=32 |
9 | VivaChek Biotech (Hangzhou) Co., Ltd | VivaDiag™ | SARS-CoV-2 IgM/IgG Rapid Test (Colloid Gold) | In vitro qualitative assay to detects IgM and IgG antibodies against SARS-CoV-2 | 15 min | Whole blood (fingertip/venous), serum or plasma | CE-IVD | NR | https://www.vivachek.com/vivachek/English/prods/prod-rapidtest.html |
10 | Xiamen AmonMed Biotechnology | COVID-19 IgM/IgG test kit (Colloidal gold) | Antibody detection | Lateral flow immunoassay that detects IgM and IgG antibodies directed against SARS-CoV-2 and Rare Earth Nano Fluorescence Immunochromatography | 10 min | Human blood sample | EU (CE Mark) | NR | http://aode.juejinvr.cn/News/index |
11 | Xiamen Biotime Biotechnology Co., Ltd. | SARS-CoV-2 IgG/IgM Rapid Qualitative Test Kit | IgG/IgM combine detection | Rapid Qualitative analysis for IgM and IgG antibodies | 15 min | Serum, plasma, whole blood | EU, CE-IVD | NR | http://www.biotime.cn/En |
12 | Zhejiang Orient Gene Biotech | COVID-19 IgG/IgM Rapid Test kit | COVID-19 IgG/IgM Rapid Test | Solid-phase immunochromatographic assay | 2-10 min | Serum/plasma or whole blood specimens | US sublicensed distribution rights from L.B. Resources (Hong Kong) | NR | https://stocknewsnow.com/companynews/5035338834942348/AYTU/101843 |
13 | Quidel Corporation | Sofia 2 SARS Antigen FIA | SARS-CoV-2 Antigen detection | Immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2 | 15 min | Nasal swab, nasopharyngeal swab | FDA EUA | NR | https://www.quidel.com/immunoassays/rapid-sars-tests/sofia-2-sars-antigen-fia |
14 | Avacta Group plc | Affimer® biotherapeutics and reagents | COVID-19 antigen detection | COVID-19 antigen test method using Adeptrix’s proprietary bead-assisted mass spectrometry (BAMS™) platform | NR | Saliva, nasopharyngeal swabs or serum | CE (Europe), FDA (USA) | NR | https://avacta.com/avacta-ships-sars-cov-2-affimer-reagents-to-cytiva-and-adeptrix/?utm_content=129011567&utm_medium=social&utm_source=twitter&hss_channel=tw-2279270671 |
15 | Coris Bio Concept | CORIS COVID-19 Ag Respi-Strip | COVID-19 antigen detection | Immunochromatography assay based on a membrane technology with colloidal gold nanoparticles fabricated with monoclonal antibodies directed against the conserved nucleoprotein antigen of SARS-CoV-2 | 15 min | Nasopharyngeal specimens | EU, CE-IVD | 1,25 X104 pfu/ml | https://www.intermed.be/en/professional-products/laboratory-diagnostics/serology-amp-virology/rapid-test/coris-covid-19-ag-respi-strip.html |
(C) Digital radiographical analysis / Sensing system: | |||||||||
Sr. No |
Developer |
Commercial Brand Name |
Analytical Method |
Technical Details |
Detection Time |
Clinical Sample |
Status |
Limit of Detection / Detection Ability |
Links |
1 | Beijing Infervision Technology Co. Ltd | InferRead CT Pneumonia | AI-based system to detect coronavirus infection via CT scans | Imaging assisted-diagnosis for multiple body areas, but not limited to brain, lung, skeleton, and bone | >20 sec | Physical presence of suspect or patient | Validated | NR | https://global.infervision.com/ |
2 | Canary Health Technologies | AiroStotleCV19 | Path Sensors technology which is exclusively licensed from MIT-Lincoln Laboratory, offering cutting-edge pathogen detection capabilities to a variety of industries including food safety, agriculture, and bioterrorism. | Three instrumentation platforms based PathSensors for easy and rapid detection. | > 5 min | Environmental swabs and air monitoring in sensitive spaces such as hospitals, offices, food services, etc | Proof-of-concept | NR | https://news.thomasnet.com/fullstory/new-canary-biosensor-generates-test-results-in-less-than-5-minutes-40034701 |
List of abbreviations: - NR: Not Reported; RT-PCR: Reverse Transcriptase-Polymerase Chain Reaction / qPCR: qualitative Polymerase Chain Reaction; RUO: Research Use Only; CE – IVD: Conformité Européenne (CE certification)-in vitro diagnostics; EUA: Emergency Use Authorization / EU – Emergency Use; FDA: Food and Drug Administration; HSA: Health and Safety Authority / Health and Sciences Authority.