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. 2020 Jun 8;165:112361. doi: 10.1016/j.bios.2020.112361

Table 1.

Table indicating recently developed analytical procedures for detection of COVID-19, (A) Oligonucleotide based molecular detection, (B) Point-of-Care Immunodiagnostics, and (C) Digital Imaging/Sensing system.

(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.