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 |
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) |