Idanwo Rapid ti aarun ayọkẹlẹ A+B Antigen ti ni idanwo ni akawe pẹlu RT-PCR.539 nasopharyngeal swabs ati oropharyngeal swabs ni a ṣe ayẹwo pẹlu Aarun ayọkẹlẹ A + B Igbeyewo Rapid.
Awọn nkan elo | Ifojusi | Awọn nkan elo | Ifojusi |
Imu Sokiri | 15% v/v | Hemoglobin | 10% v/v |
Mucin | 0.5% w/v | Mupirocin | 10 mg/ml |
Imu Silė | 15% v/v | Fọ ẹnu | / |
Chloraseptic | 1.5 mg/ml | Levofloxacin | 40 ug/ml |
Oseltamivir | 2ug/ml | Ribavirin | 0.2ug/ml |
Fluticasone propionate | 5% v/v | Ceftriaxone | 800 ug/ml |
Tobramycin | 4ug/ml | Saline Imu Sokiri | 10% v/v |
Fun aarun ayọkẹlẹ A
Ọna | RT-PCR | Lapapọ esi | ||
Aarun ayọkẹlẹ A + B Igbeyewo Rapid | Awọn abajade | Rere | Odi | |
Rere | 116 | 1 | 117 | |
Odi | 5 | 417 | 422 | |
Lapapọ esi | 121 | 418 | 539 |
Ifamọ ile-iwosan: 95.87% (95% CI: 90.69% ~ 98.22%)
Ni pato ile-iwosan: 99.76% (95% CI: 98.66% ~ 99.96%)
Lapapọ Oṣuwọn Ibaṣepọ: 98.89% (95% CI: 97.59% ~ 99.49%).
Fun aarun ayọkẹlẹ B:
Ọna | RT-PCR | Lapapọ esi | ||
Aarun ayọkẹlẹ A + B Igbeyewo Rapid | Awọn abajade | Rere | Odi | |
Rere | 97 | 1 | 98 | |
Odi | 6 | 435 | 441 | |
Lapapọ esi | 103 | 436 | 539 |
Ifamọ ile-iwosan: 94.17% (95% CI: 87.87% ~ 97.30%)
Ni pato ile-iwosan: 99.77% (95% CI: 98.71% ~ 99.96%)
Lapapọ Oṣuwọn Ibaṣepọ: 98.70% (95% CI: 97.34% ~ 99.37%).
Analitikali ifamọ / LOD
Hangzhou Aichek Medical Technology CO., Ltd. Jinxing Cun, Agbegbe Yuhang, Yuhang Agbegbe (Ilu Sci-Tech Ọjọ iwaju), Hangzhou, Zhejiang, PR China | |
SUNGO Europe BV Olympisch Stadion 24, 1076DE Amsterdam, Netherlands |
Idiwọn wiwa (LOD) jẹ idanimọ nipasẹ ṣiṣe iṣiro awọn ifọkansi oriṣiriṣi ti ọlọjẹ Aarun ayọkẹlẹ ati ọlọjẹ aarun ayọkẹlẹ B ninu Aarun ayọkẹlẹ A+ B Antigen Rapid Test.Awọn ifọkansi ti a damọ bi awọn ipele LOD ti idanwo ti wa ni akojọ si isalẹ.
Aarun ayọkẹlẹ A (H3N2): 5× 103 TCID50/ml
Aarun ayọkẹlẹ A (H1N1): 2.5×103 TCID50/ml
Aarun ayọkẹlẹ A (H1N1 pdm09): 2.5×103 TCID50/ml
Aarun ayọkẹlẹ B (Yamagata): 3.5× 103 TCID50/ml
Aarun ayọkẹlẹ B (Victoria): 1.0× 103 TCID50/ml
Ni pato Analitikali (Aṣetunṣe Agbelebu)
Lati pinnu pato analitikali ti Aarun ayọkẹlẹ A + B Antigen Rapid Test, ọpọlọpọ awọn commensal tabi awọn microorganisms pathogenic ti o le wa ni apa atẹgun oke ni idanwo.
Awọn apẹẹrẹ ti o dara ati odi ni a spiked pẹlu awọn microbes wọnyi ni a ṣe ayẹwo ni ifọkansi ti 106 TCID50/mL, pẹlu SARS-CoV-2, coronavirus Human HKU1, OC43, NL63, 229E, MERS, Rhinovirus, Adenovirus, Enterovirus, Metapneumovirus, Parainfluen kokoro syncytial, Mycoplasma pneumonia, Chlamydia pneumonia, Streptococcus pneumonia, Staphylococcus aureus, Mycobacterium iko, Haemophilus influenzae, Streptococcus pyogenes.Ko si ifisi-agbelebu ti a rii pẹlu Aarun ayọkẹlẹ A+B Antigen Rapid Test.
Aarun ayọkẹlẹ A + B Antigen Rapid Test jẹ imunoassay ṣiṣan ita ti a pinnu fun wiwa aarun ayọkẹlẹ A ati aarun ayọkẹlẹ B antigens ni swab nasopharyngeal ati swab oropharyngeal.
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