Ubuvuzi ukoreshe ibikoresho bya tifoyide yumwuga, intambwe imwe yihuta yo kwipimisha

Ibyiyumvo bya Clinical, Umwihariko nukuri

Ibicurane A + B Antigen yihuta yapimwe ugereranije na RT-PCR.539 nasopharyngeal swabs na oropharyngeal swabs basuzumwe hamwe na Grippe A + B Ikizamini cyihuse.

Ibicurane A.

Ibyiyumvo byubuvuzi ： 95.87% (95% CI: 90.69% ~ 98.22%)
Ubuvuzi bwihariye ： 99,76% (95% CI: 98,66% ~ 99,96%)
Igipimo rusange cy'impanuka ： 98.89% (95% CI: 97.59% ~ 99.49%).

Ibicurane B:

Ibyiyumvo byubuvuzi ： 94.17% (95% CI: 87.87% ~ 97.30%)
Ubuvuzi bwihariye ： 99,77% (95% CI: 98,71% ~ 99,96%)
Igipimo rusange cy'impanuka ： 98.70% (95% CI: 97.34% ~ 99.37%).

Isesengura Rikomeye / LOD

	Hangzhou Aichek Ikoranabuhanga mu buvuzi CO., Ltd. Jinxing Cun, Umuryango Yuhang, Yuhang Akarere (Umujyi wa Sci-Tech Umujyi), Hangzhou, Zhejiang, PR Ubushinwa
	SUNGO Europe BV Stade ya Olympisch 24, 1076DE Amsterdam, Ubuholandi

Umupaka wo gutahura (LOD) wagaragajwe no gusuzuma ibipimo bitandukanye bya virusi ya grippe A na virusi ya grippe B mu kizamini cya Antigen Rapid Grippe A + B.Ibitekerezo byagaragaye nkurwego rwa LOD rwageragejwe urutonde hepfo.
Ibicurane A (H3N2): 5 × 103 TCID50 / mL
Ibicurane A (H1N1): 2.5 × 103 TCID50 / mL
Ibicurane A (H1N1 pdm09): 2.5 × 103 TCID50 / mL
Ibicurane B (Yamagata): 3.5 × 103 TCID50 / mL
Ibicurane B (Victoria): 1.0 × 103 TCID50 / mL

Isesengura ryihariye (Umusaraba Reactivite)

Kugirango hamenyekane isesengura ryihariye rya Grippe A + B Antigen Rapid yihuta, hapimwe mikorobe nyinshi zisanzwe cyangwa zitera indwara zishobora kuba mubice byubuhumekero bwo hejuru.
Ingero nziza kandi mbi zatewe hamwe na mikorobe zapimwe ku gipimo cya 106 TCID50 / mL, harimo SARS-CoV-2, Coronavirus HKU1, OC43, NL63, 229E, MERS, Rhinovirus, Adenovirus, Enterovirus, Metapneumovirus, Parainfluenza, Respiratory virusi ya syncytial, umusonga Mycoplasma, umusonga wa Chlamydia, umusonga wa Streptococcus, Staphylococcus aureus, Mycobacterium igituntu, ibicurane bya Haemophilus, pyptène Streptococcus.Nta reaction-reaction yagaragaye hamwe na Grippe A + B Antigen Yihuta.

UKORESHEJWE

Ibicurane A + B Antigen yihuta ni immunoassay itembera igenewe kumenya ibicurane byujuje ubuziranenge A na grippe B muri nasopharyngeal swab na oropharyngeal swab.

Ibyiza bya sosiyete

1.Umwuga wumwuga, urwego rwigihugu rwikoranabuhanga ruteye imbere "igihangange"
2.Gutanga ibicuruzwa nkuko ubisaba
3.ISO13485, CE, Tegura inyandiko zitandukanye zo kohereza
4. Subiza abakiriya ibibazo mumasaha 24