China China Chino Chengetedza Mutengo Werufu Rapid 2019 - NCOV CORONAVIRUS Anigen Test - Immuno
China China Chino Chengetedza Mutengo Werufu Rapid 2019 - NCOV Coronavirus Angent Test - Impundietail:
Iyo Imunobio Rapid Coronavirus Angent Test Kit iri Rapid Dection Nzira yeCovid - 19 Antigen. Anti - 2019 - NCOV Monowlonal Anti Coated paTest Linderd.dise link.dise yakaedzwa neAnti - Musanganiswa wacho wobva watanga membrane neCapillarary chiito uye akaita neimwe anti - 2019 - NCOV Monowlonal Anti Bound of the test nzvimbo.
Iyo Imunobio Antigen Test Kit iri Kukurumidza Kuedza Kwekukasira Kuwanikwa kweAnights kuNovel Coronavirus Sars - COV - Yehunyanzvi mu vitro diagnostics chete
Maitiro ekuita
1. Sensitivity, chokwadi uye kururamisa surs - CO - Mhedzisiro yacho yakaratidza kusangana kwehama uye chokwadi
Nzira | Goridhe Standard Reagent (PCR) | Zvapera | ||
SAS - COV - 2 Antigen Rapid Test (Chand - 19 aG) | Mhedzisiro | Zvakanaka | Zvisina kunaka | |
Zvakanaka | 87 | 0 | 87 | |
Zvisina kunaka | 4 | 300 | 304 | |
Mhedzisiro Yese | 60 | 300 | 391 |
Yakasarudzika Inzwa: 95.60% (95% CI: 88.89% ~ 98.63%)
Yakati Rondedzero: 100% (95% CI: 98.78% ~ 100,00%)
Kunyatso: 98.98% (95% CI: 97.30% ~ 99.70%)
2. Kuganhurira kwekuonekwa (Lood)
Muganho wekuonekwa weSers - COV - 2 Antigen Rapid Test (Chandd - 19 AG) yakadzidzwa. Iyo LOD yeRuyedzo kuShariya - COV -2 Tcid50/ ml
Kusvinura | Yakanaka / mhedzisiro | Chibvumirano Chibvumirano |
0.5ng / ml n protein | 100/100 | 100% |
5x102 Tcid50/ ml | 100/100 | 100% |
3. Cross - Zvakaitika:
Anopaza - COV - Mhedzisiro yakaratidza mupepa pazasi:
Chinhu | Kusvinura | Mhedzisiro |
Sars - COV - 2 n Prappiin | 0.001μg / ml | zvakanaka |
Sars - cov n protein | 1μG / ML | zvisina kunaka |
Mers - COV N Prapliin | 1μG / ML | zvisina kunaka |
HCOV - NL63 N Prapliin | 1μG / ML | zvisina kunaka |
HCOV - 229E N Prappiin | 1μG / ML | zvisina kunaka |
HCOV - HKU1 N Prapliin | 1μG / ML | zvisina kunaka |
Parainfluena Virus | 1x105Tcid50/ ml | zvisina kunaka |
Furuwenza hutachiona | 1x105Tcid50/ ml | zvisina kunaka |
Kufudza Bhutu | 1x105Tcid50/ ml | zvisina kunaka |
Chlamydia pneumoniae | 1x105Tcid50/ ml | zvisina kunaka |
Adenovirus | 1x105Tcid50/ ml | zvisina kunaka |
Mycoplasma pneumoniae | 1x105Tcid50/ ml | zvisina kunaka |
Utachiona hunokanganisa zvakanyanya nhengo dzekufema nadzo | 1x105Tcid50/ ml | zvisina kunaka |
4. InterFering zvinhu:
Iwo anotevera makomputa akaedzwa uchishandisa maSers - COV - 2 Antigen Rapid Test (Covid - 19 AG) uye hapana kupindira kwakacherechedzwa.
Chinhu | Kusvinura | Mhedzisiro |
Alpha - Interferon | 3millioniu | Hapana kupindira |
Akacheneswa mucin | 1000ng / ML | Hapana kupindira |
Yakatenderwa Certification
1. CE / ISO13485 / chena runyorwa
2. Kunyoresa muGerman Ushumiri hwehutano
Kuongorora maitiro
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Related Ordey gwara:
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