I-Influenza A+B Antigen Rapid Test ihloliwe uma iqhathaniswa ne-RT-PCR.539 ama-nasopharyngeal swabs kanye nama-oropharyngeal swabs ahlolwe ngokuhlolwa okushesha komkhuhlane we-A+B.
Izinto | Ukugxila | Izinto | Ukugxila |
Isifutho Amakhala | 15% v/v | IHemoglobin | 10% v/v |
Mucin | 0.5 % w/v | I-Mupirocin | 10 mg/mL |
Amathonsi Amakhala | 15% v/v | Ukugeza umlomo | / |
I-Chloraseptic | 1.5 mg/mL | Levofloxacin | 40 ug/mL |
I-Oseltamivir | 2ug/mL | I-Ribavirin | 0.2ug/mL |
I-Fluticasone propionate | 5% v/v | I-Ceftriaxone | 800 ug/mL |
I-Tobramycin | 4ug/mL | I-Saline Nasal Spray | 10% v/v |
Ngomkhuhlane A
Indlela | I-RT-PCR | Isamba Semiphumela | ||
Ukuhlolwa Okusheshayo Komkhuhlane A+B | Imiphumela | Okuhle | Okubi | |
Okuhle | 116 | 1 | 117 | |
Okubi | 5 | 417 | 422 | |
Isamba Semiphumela | 121 | 418 | 539 |
Ukuzwela komtholampilo: 95.87% (95% CI: 90.69% ~ 98.22%)
Ukucaciswa komtholampilo:99.76% (95% CI: 98.66%~99.96%)
Isamba sezinga lokuqondana:98.89% (95% CI: 97.59%~99.49%).
Ngomkhuhlane B:
Indlela | I-RT-PCR | Isamba Semiphumela | ||
Ukuhlolwa Okusheshayo Komkhuhlane A+B | Imiphumela | Okuhle | Okubi | |
Okuhle | 97 | 1 | 98 | |
Okubi | 6 | 435 | 441 | |
Isamba Semiphumela | 103 | 436 | 539 |
Ukuzwela komtholampilo: 94.17% (95% CI: 87.87% ~ 97.30%)
Ukucaciswa komtholampilo:99.77% (95% CI: 98.71%~99.96%)
Isamba sezinga lokuqondana:98.70% (95% CI: 97.34%~99.37%).
Ukuzwela Kokuhlaziya/LOD
I-Hangzhou Aichek Medical Technology CO., Ltd. Jinxing Cun, Yuhang Community, Yuhang Isifunda (Idolobha Elizayo Sci-Tech), i-Hangzhou, Zhejiang, PR China | |
I-SUNGO Europe BV I-Olympisch Stadion 24, 1076DE Amsterdam, Netherlands |
Umkhawulo wokutholwa (i-LOD) uhlonzwe ngokuhlola ukugxila okuhlukene kwegciwane lomkhuhlane A kanye negciwane lomkhuhlane B ku-Influenza A+B Antigen Rapid Test.Ukugxila okuhlonzwe njengamazinga e-LOD ahloliwe kubhalwe ngezansi.
Umkhuhlane A (H3N2): 5×103 TCID50/mL
Umkhuhlane A (H1N1): 2.5×103 TCID50/mL
Umkhuhlane A (H1N1 pdm09): 2.5×103 TCID50/mL
Umkhuhlane B (Yamagata): 3.5×103 TCID50/mL
Umkhuhlane B (Victoria): 1.0×103 TCID50/mL
Ukucaciswa Kokuhlaziya (Ukuphinda Usebenze kabusha)
Ukuze kutholwe ukucaciswa kokuhlaziya Kokuhlolwa Okusheshayo Komkhuhlane A+B, ama-microorganisms ambalwa e-commensal noma e-pathogenic angase abe khona endaweni yokuphefumula ephezulu ahlolwe.
Ama-specimens amahle noma angalungile afakwe kulawa magciwane ahlolwa ekugxilweni kwe-106 TCID50/mL, okuhlanganisa i-SARS-CoV-2, i-Human coronavirus HKU1, OC43, NL63, 229E, MERS, Rhinovirus, Adenovirus, Enterovirus, Metapneumoviruse, I-Revrunavirus syncytial virus, Mycoplasma pneumonia, Chlamydia pneumonia, Streptococcus pneumonia, Staphylococcus aureus, Mycobacterium tuberculosis, Haemophilus influenzae, Streptococcus pyogenes.Akukho ukusabela okuphambene okubonwe nge-Influenza A+B Antigen Rapid Test.
Ukuhlolwa Okusheshayo Komkhuhlane A+B I-Antigen Rapid Test iyi-assay yokugeleza yangemuva ehloselwe ukuthola ikhwalithi yomkhuhlane A kanye nama-antigens omkhuhlane B ku-nasopharyngeal swab kanye ne-oropharyngeal swab.
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3.ISO13485, CE, Lungiselela imibhalo ehlukahlukene yokuthumela
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