Isitifiketi se-EU I-IVDR se-STREP A Rapid Antigen Test Kit

I-Colourcom Bio Diagnostics Imemezela Isitifiketi se-EU I-IVDR ye-STREP APASD Antigen Test Kit.



I-Hangzhou, China - UColorcom Bio, Umholi Wezixazululo Zomhlaba Wonke, namuhla umemezele ukuthi i-strup yayo i-antigen Test Kit ithole ngempumelelo i-Class C Ukuhlonza i-Europeen in Vitro Diagnostic Regudte (IvDR, EU 2017/746). Le mpistone igcizelela ukuhambisana komkhiqizo ngokuphepha okuqinile, ukusebenza kahle, nokuyibeka njengekhambi elithembekile kulokwethulwa kwasekhaya kweqembu i-streptococcus (igesi) emhlabeni jikelele.

Uhlaka lwe-IvDR, lwenziwe ukubeka phambili ukuphepha kwemitholampilo kanye nokusobala, amagunya okuhlola ukusebenza kanzima, ukuqinisekiswa kwemitholampilo kanye nokukhiqiza amakhono wekhwalithi. Isitifiketi seColorcom Bio sibonisa ukuhambisana namabhentshi wembulunga yonke, ukunika amandla ukuthunyelwa okusheshayo kuwo wonke amalungu angama-27 amalungu angama-EU nokuqinisa indima yaso ekulweni nokuphikiswa okukhohlisayo ngokuxilongwa okuhlosiwe.

Group a streptococcus (igesi), imbangela ehamba phambili ye-pharyngitis kanye nomkhuhlane obomvu, kunomthelela ekufeni kwabantu emhlabeni wonke okungaphezulu kuka-500,000 ngonyaka. Izindlela zendabuko zama-bacterikala ama-bacterial, noma zinembile, zidinga amahora angama-24 - amahora angama-48 ukuthola imiphumela. I-Colourcom Bio's Kit ihambisa iLebhu - Ukunemba okuqhathaniswa kungakapheli imizuzu emi-5, kunikeze amandla amakhaya, izikole kanye nemitholampilo ukwenza izinqumo ezifika ngesikhathi. Izinzuzo ezibalulekile zifaka:

- > 95% SENSICICAL Sensitivity & Ukucaciswa

- Umsebenzisi - Idizayini enobungane: Akukho ukuqeqeshwa okukhethekile okudingekayo

- Isicelo esimbaxambili: Kuqinisekiswe kubo bobabili abadala nezingane (ubudala 3+)

Okwesithathu elula - Ukuhlolwa kwesinyathelo

Qoqa: Shintsha indawo yeTonsoat Tonsil.

Inqubo: Hlanganisa i-swab nge-extraction buffer futhi ufake isicelo kukhasethi yokuhlola.

Funda: Imiphumela ebonakalayo emizuzwini emi-5 ecacile / emibi emibi.

Ngokunika amandla ukutholwa kusenesikhathi, ikhithi isiza ukunciphisa ukusetshenziswa kwe-antibiotic okungadingekile futhi ivikele ubunzima obunzima njengomkhuhlane we-rheumatic.