Table 1. Nucleic Acid Amplification Tests Available in Japan (January 22, 2021).

From: Microbiological Testing for Coronavirus Disease 2019

Methods Product name Sales company in Japan Turnaround time Approved as in vitro diagnostics Measuring device
Quantitative reverse transcription-polymerase chain reaction (RT-qPCR) 2019 novel coronavirus (nCoV) fluorescence real-time RT-PCR kit Sysmex Corporation 90 min, except time to extract nucleic acid Yes
MEBRIGHT SARS-CoV-2 Kit MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. 90 min, except time to extract nucleic acid Yes
SARS-CoV-2 GeneSoC N2 Kyorin Kyorin Pharmaceutical Company, Limited 15 min, except time to extract nucleic acid No GeneSoC
SARS-CoV-2 RT-qPCR Detection Kit Ver. 2 FUJIFILM Wako Pure Chemical Corporation 50 min, except time to extract nucleic acid*1 No
Direct RT-qPCR Ampdirect 2019-nCoV Detection Kit SHIMADZU CORPORATION 70 min Yes
SGNP nCoV/Flu PCR Detection kit SUDx-Biotec Corporation 20-60 min Yes
Takara SARS-CoV-2 direct PCR detection kit Takara Bio Inc. 60 min Yes
TaqPath SARS-CoV-2 real-time PCR detection kit HT Life Technologies Japan Ltd. 60 min Yes
SARS-CoV-2 Detection Kit -Multi- TOYOBO CO., LTD. 60 min No
SARS-CoV-2 gene detection kit KYOKUTO Ver. 2 KYOKUTO PHARMACEUTICAL INDUSTRIAL CO., LTD. 60 min No
SARS-CoV-2 detection kit KUBIX Inc. 60 min No
KANEKA Direct RT-qPCR Kit "SARS-CoV-2" KANEKA CORPORATION 60 min No
GENECUBE HQ SARS―CoV-2 TOYOBO CO., LTD 35 min Yes GENECUBE
Cobas SARS-CoV-2 & Flu A/B Roche Diagnostics K.K. 180 min (96 tests) Yes Cobas 6800
Cobas 8800
i-densy Pack SARS-CoV-2 ARKRAY Factory, Inc. 80 min Yes i-densy IS-5320
BD Max SARS-CoV-2 Nippon Becton Dickinson Company, Ltd. 120-180 min (24 tests) No BD Max
ELITe MGB SARS-CoV-2 Kit Precision System Science Co., Ltd. 150 min (12 tests) No ELITeInGenius
VIASURE SARS-CoV-2 Kit Precision System Science Co., Ltd. 90-120 min (8 tests) No geneLEADVIII
μTAS Wako COVID-19 FUJIFILM Wako Pure Chemical Corporation 75 min No μTAS Wako g1
Point-of-care test (POCT) RT-qPCR Xpert Xpress SARS-CoV-2 “Cepheid” Beckman Coulter, Inc. 45 min Yes GeneXpert
FilmArray Respiratory 2.1 panel bioMérieux Japan Ltd. 45 min Yes FilmArray
SmartGene SARS-CoV-2 detection kit MIZUHO MEDY Co., Ltd. 70 min No SmartGene
Isothermal amplification Loopamp SARS-CoV-2 detection kit EIKEN CHEMICAL CO., LTD. 35 min, except time to extract nucleic acid*2 Yes Loopamp EXIA*3
SmartAmp SARS-CoV-2 detection kit K.K.DNAFORM. 30 min, except time to extract nucleic acid Yes
Direct isothermal amplification SARS-CoV-2 RNA detection kit TRCReady SARS CoV 2 i TOSOH CORPORATION 40 min Yes TRCReady-80
SARS-CoV-2 detection kit LAMPdirect Genelyzer KIT CANON MEDICAL SYSTEMS CORPORATION 30 min No Genelyzer FIII
Genelyzer FII
Genelyzer F-MS
Aptima SARS-CoV-2 Hologic Japan, Inc. 210 min (275 tests/8 hours) Yes Panther system
POCT isothermal amplification ID NOW SARS-CoV-2 Abbott Diagnostics Medical Co., Ltd. 13 min Yes ID NOW
Table 2. Sensitivity and Specificity of Nucleic Acid Amplification Tests in Each Specimen Based on Nasopharyngeal Swab as a Reference.

From: Microbiological Testing for Coronavirus Disease 2019

Sensitivity Specificity
Saliva collected from patients without cough 0.90 (95% confidence interval (CI), 0.85-0.93) 0.98 (95% CI, 0.93-1.00)
Saliva collected from patients with cough 0.99 (95% CI, 0.94-1.00) 0.96 (95% CI, 0.83-0.99)
Oropharyngeal swab 0.76 (95% CI, 0.58-0.88) 0.98 (95% CI, 0.96-0.99)
Nasal vestibular swab 0.89 (95% CI, 0.83-0.94) 1.00 (95% CI, 0.99-1.00)
Middle turbinate swab 0.95 (95% CI, 0.83-0.99) 1.00 (95% CI, 0.89-1.00)
Nasal vestibular and oropharyngeal swab 0.95 (95% CI, 0.69-0.99) 0.99 (95% CI, 0.92-1.00)
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