Xirmada Tiifowga ee xirfadda u leh isticmaalka caafimaadka, hal tallaabo oo cajalad tijaabo ah oo degdeg ah

Dareenka Kiliinikada, Gaarka ah iyo Saxnaanta

Tijaabada degdega ah ee hargabka A+B ayaa la tijaabiyay marka la barbar dhigo RT-PCR.539 naasopharyngeal swabs iyo suufka oropharyngeal ayaa lagu qiimeeyay hargabka A+B Tijaabada Degdega ah.

Hargabka A

Dareenka bukaan-socodka: 95.87% (95% CI: 90.69% ~ 98.22%)
Gaar ahaan caafimaad ahaan: 99.76% (95% CI: 98.66% ~ 99.96%)
Wadarta heerka isku dhaca:98.89% (95% CI: 97.59%~99.49%).

Hargabka B:

Dareenka bukaan-socodka: 94.17% (95% CI: 87.87% ~ 97.30%)
Gaar ahaan caafimaad ahaan: 99.77% (95% CI: 98.71% ~ 99.96%)
Wadarta heerka isku dhaca:98.70% (95% CI: 97.34%~99.37%).

Dareenka Analytical/LOD

	Hal qayb oo ka mid ah Hangzhou Aichek Medical Technology Co., Ltd. Jinxing Cun, Beesha Yuhang, Yuhang Degmada (Mustaqbalka Sci-Tech City), Hangzhou, Zhejiang, PR Shiinaha
	SUNGO Europe BV Olympisch Stadion 24, 1076DE Amsterdam, Netherlands

Xadka ogaanshaha (LOD) ayaa lagu aqoonsaday iyadoo la qiimeeyay xadiga kala duwan ee fayraska hargabka A iyo fayraska hargabka B ee Tijaabada Degdega ah ee Hargabka A+B.Xaddiga loo aqoonsaday heerarka LOD ee la tijaabiyay ayaa hoos ku taxan.
Hargabka A (H3N2): 5×103 TCID50/ml
Hargabka A (H1N1): 2.5×103 TCID50/ml
Hargabka A (H1N1 pdm09): 2.5×103 TCID50/ml
Hargabka B (Yamagata): 3.5×103 TCID50/ml
Hargabka B (Victoria): 1.0×103 TCID50/ml

Gaarka ah Analytical (Reactivity Cross)

Si loo go'aamiyo qaas ahaanta falanqaynta Hargabka A+B Antigen Degdegga ah, dhowr jeermiska bakteeriyada ee laga yaabo inay ku jiraan mareenka neefsashada sare ayaa la tijaabiyay.
Tijaabooyin togan iyo kuwa taban ayaa lagu tufay microbes-kan waxa lagu qiimeeyay 106 TCID50/mL, oo ​​ay ku jiraan SARS-CoV-2, Human coronavirus HKU1, OC43, NL63, 229E, MERS, Rhinovirus, Adenovirus, Enterovirus, Metapneumovirus, Parainflu. Fayraska syncytial, Mycoplasma oof-wareen, Chlamydia oof-wareen, Streptococcus pneumonia, Staphylococcus aureus, Qaaxada Mycobacterium, Haemophilus influenzae, Streptococcus pyogenes.Wax falcelin iskutallaab ah laguma arag Tijaabada Degdegga ah ee Hargabka A+B.

ISTICMAALKA KULAN

Hargabka A+B Antigen Rapid Test waa immunoassay socodka lateral ee loogu talagalay in lagu ogaado hargabka A iyo hargabka B antigens ee sanka sanka iyo suufka oropharyngeal.

Faa'iidada Shirkadda

1. Soosaaraha Xirfadlaha ah, oo ah shirkad tignoolajiyadeed heer qaran ah oo heer qaran ah
2. U geyso badeecada dalabka dalabka
3.ISO13485, CE, Diyaari dukumeenti dhoofinta kala duwan
4. Ku jawaab su'aalaha macaamiisha 24 saacadood gudahood