SARS-CoV-2 Nucleic Acid Tests: progress of the active applications in the emergency use listing assessment pipeline

Dossier QMS Desk

Product name Product code(s) Manufacturer name
review Assessment
Liferiver Novel Coronavirus (SARS-CoV-2) Real Time Multiplex RT-
PCR
RR-0479-02 Shanghai ZJ Bio-Tech Co., Ltd 1 F
3DMed 2019-nCoV qRT-PCR Detection Kit 3103010011 3D Biomedicine Science & Technology Co., Ltd. 1 u
SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe
Method)
1.10.11.09.nc.02 Zybio Inc. 1 u
Multiple Real-Time PCR Kit for Detection of 2019-nCoV CT8233-48T Beijing Applied Biological Technologies Co. Ltd (XABT) 1 u
SARS-CoV-2 Nucleic Acid Test (Real-time PCR) KH-G-M-574-48 Shanghai Kehua Bioengineering Co., Ltd. 1 R
SARS-CoV-2 Virus Detection Diagnostic Kit (RT-qPCR Method) XC25073 Ningbo Health Gene Technologies Co., Ltd. R u
VERI-Q PCR 316 COVID-19 Detection System 7K105 MiCo BioMed Co., Ltd. R u
DirectDetect SARS-COV2 Detection Kit (PCR-Fluorescence Probe) QJR Coyote Bioscience Co., Ltd R R
Bio-Speedy SARS-COV2 (2019-nCoV) qPCR Detection Kit BS-SY-WCOR-303-100 Bioeksen R&D Technologies Ltd. 1 R
Wantai SARS-CoV-2 RT-PCR WS-1248 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd 1 u
FTD-114 SARS-CoV-2 FTD-114-32 Fast Track Diagnostics Luxembourg S.à r.l. F u
awaiting awaiting
Smart Detect SARS-CoV-2 rRT-PCR Kit COV2-E InBios International, Inc.
submission submission

CoVTest-SR to be confirmed Shenrui Biopharmaceuticals Co., Ltd. closed closed

RT- PCR kit for Detecting SARS - CoV-2 （Real-time fluorescent

PCR ） to be confirmed HaploX Biotechnology Co., LTD closed closed

COVID-19 Real-Time PCR Kit HBRT-COVID-19 Chaozhaou Hybribio Biochemistry Ltd. u closed

2019-Novel Coronavirus (ORF1ab, E & N genes) nucleic acid test kit

(Fluorescent Probe-based real-time PCR assay)
R205T050B0C0 Jiangsu Mole Bioscience Co.,Ltd. 1 R
Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit
(fluorescence PCR)
081 Beijing Kinghawk Pharmaceutical Co. Ltd. 1 R
Xpert Xpress SARS-CoV-2 XPRSARSCOV2-10 Cepheid F u
 SARS-CoV-2 Nucleic Acid Tests: progress of the active applications in the emergency use listing assessment pipeline

Dossier QMS Desk

Product name Product code(s) Manufacturer name
review Assessment
SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescent RT-RAA) F02R13A-48 Jiangsu Qitian Gene Biotechnology Co., Ltd. R R
Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Real Time
PCR)
GZ-D2RM25 Shanghai GeneoDx Biotechnology Co., Ltd) 1 R
Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-
Fluorescence Probing)
S3103E Sansure Biotech Inc. 1 R
COVID-19 Coronavirus Real Time PCR Kit JC10223-1NW-25T, JC10223-1NW-50T Jiangsu Bioperfectus Technologies Co.,Ltd 1 R
Fosun 2019-nCoV qPCR (Novel Coronavirus (2019-nCoV) RT-PCR
Detection Kit)
PCSYHF Shanghai Fosun Long March Medical Science Co., Ltd. 1 R
SARS-CoV-2 Nucleic acid detection kit based on Real-Time PCR
platform
PGA4102P2 Tellgen Corporation, Shanghai 1 u
Genskey SARS-CoV-2 RT-PCR Kit Q102 Tianjin GensKey Medical Technology Co., Ltd. 1 1
StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time awaiting awaiting
500190 Liming Bio-Products Co., Ltd.
PCR Kit (detection for three genes) submission submission

SARS-CoV-2 (ORF1ab/N) Nucleic Acid Detection Kit (PCR- awaiting awaiting

SUPI-2501 Guangzhou Supbio Bio-technology and Science Co., Ltd
Fluorescent Probe) submission submission

careGENE COVID-19 RT-PCR kit MCDN05082 Wells Bio Inc. R R

Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal
Amplification- Real Time Fluorescence Assay)
U20223 UStar Biotechnologies (Hangzhou) Ltd. 1 1
Wuhan EasyDiagnosis Biomedicine
COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit 20203400212
Co., Ltd. R 1
LightPower iVA SARS-CoV-2 1st RT-rPCR kit VA.A02-055H Viet A Technology corporation 1 1
TaqPath Covid-19 Combo Kit A47814 Thermo Fischer Scientific F R
Simplexa COVID-19 Direct and Simplexa COVID-19 Positive control
Pack
MOL4150, MOL4160 DiaSorin 1 R
awaiting awaiting
One-Step RT-PRC COVID-19 kit Thai Duong Version 1.0 SK128COVO1 Sunstar Joint Stock Company
submission submission
awaiting awaiting
SAMBA II SARS-CoV-2 Test 8500-12 Diagnostics for the Real World Ltd
submission submission
 SARS-CoV-2 Nucleic Acid Tests: progress of the active applications in the emergency use listing assessment pipeline

Dossier QMS Desk

Product name Product code(s) Manufacturer name
review Assessment
SARS-CoV-2 virus Antibody Tests: progress of the active applications in the emergency use listing assessment pipeline
Dossier QMS Desk
Product name Product code(s) Manufacturer name
review Assessment
awaiting awaiting
DPP COVID-19 IgM/IgG System 65-9572-0 Chembio Diagnostic Systems Inc
submission submission

Disclaimer: This list does not reflect a decision on EUL assessment and must not be used to inform procurement as it does not constitute an endorsement or WHO listing of the products.

R 1 u F
information requested from follow-up amendments
manufacturer in process stage complete

Please note: these tables are updated regularly; while every attempt is made to provide current data, the most recent information might not be
reflected. This table is intended only as an update on progress and does not reflect a final decision on prequalification. This table should not be used
to inform procurement.Information may not yet be reflected here.
Last update: 14 May 2020