Table 1.
Nucleic Acid Amplification Tests Available in Japan (January 22, 2021).
| 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 |
“Direct” is defined as the process of nucleic acid extraction that is included in the reagents or test equipment, and “POCT” is defined as the process that does not require dispensing of reagents using micropipettes, etc., and can be handled by physicians at the bedside.
Many product names are not written in English, so they have been translated by the author and are not the official product names.
Turnaround time is based on the time indicated by each manufacturer and is only a rough guide because some specimen preparation times are not included.
*1 Nucleic acid extraction time can be reduced using “SARS-CoV-2 Lysis Buffer Ver. 2, FUJIFILM Wako Pure Chemical Corporation” (time required, 15 min).
*2 The rapid extraction reagent “Virus RNA extraction kit, EIKEN CHEMICAL CO.” is available.
*3 Visual judgment is also possible.
RT-qPCR, quantitative reverse transcription polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; POCT, point-of-care test