Ngomhlaka-30 Januwari kanye nomcimbi woNyaka Omusha waseShayina, imikhiqizo emihlanu eyenziwe yi-Macro & Micro-Test, i-Easy Amp Real-time Fluorescence Isothermal Detection System, i-Micro-Test Automatic Nucleic Acid Extractor, i-Macro & Micro-Test Viral DNA/RNA Kit, i-Macro & Micro-Test Sample Release Reagent, kanye ne-Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit ivunyiwe futhi yavunyelwa yi-US FDA ngokulandelana.
Ukudla, izidakamizwa, izimonyo kanye namadivayisi ezokwelapha avunyelwe yi-US Food and Drug Administration (FDA), eyaziwa emhlabeni wonke njengegunya lokuvunyelwa kwamadivayisi ezokwelapha, yimikhiqizo ephenywayo futhi egunyazwe yizindinganiso zomhlaba wonke ezigunyaziwe. Imikhiqizo emihlanu engenhla egunyazwe yi-FDA evela ku-Macro & Micro-Test ihlanganisa yonke inqubo yokuhlolwa kwe-nucleic.
1. Ukusampula
Osayizi ababili abahlukene, i-swab ehlanganisiwe evulekayo evulekayo, ukungasebenzi kwegciwane okusebenzayo, okusebenzayo ekutholakaleni okuxubile.
2. Ukukhishwa kwe-Nucleic Acid
● Uhlelo A
Ikhithi ye-DNA/RNA yegciwane le-Macro kanye ne-Micro-Test
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Isikhiphi se-Nucleic Acid esizenzakalelayo
I-Automatic Nucleic Acid Extractor isebenza ngephansi elilodwa kuphela, ikhulula izandla zabasebenzi bezokwelapha. Nge-Macro & Micro-Test Viral DNA/RNA Kit, inqubo yokukhipha i-nucleic acid ingaqedwa.ngemizuzu eyi-10, kusheshisa kakhulu umsebenzi futhi kunciphisa imithwalo ema-laboratory.
● Uhlelo B
I-Macro & Micro-Test Release Release Reagent
Ukusabalala kwegciwane le-SARS-CoV-2 kulethe ingcindezi enkulu kubasebenzi bezokwelapha kanye namalabhorethri, abanobunzima bokwenza izivivinyo eziningi ezivinjelwe isikhala, isikhathi, imishini kanye nabasebenzi. Uma sibheka lokhu, i-Macro & Micro-Test ithuthukise ikhambi lokukhulisa ngqo lesinyathelo esisodwa:ukukhipha isampula ngemizuzu emi-5 ngaphandle kosizo lwanoma yiluphi ithuluzi.
3. Ukwandiswa kwe-Isothermal
Uma kuqhathaniswa nokuhlolwa kwe-PCR kwendabuko, i-Easy Amp Real-time Fluorescence Isothermal Detection System, enemiphumela emihlengemizuzu emi-5, inciphise yonke inqubo yokuthola ngo-2/3. Amamojula ayo angu-4x4 aklanywe ngokuzimela aqinisekisa ukuhlolwa okufunwayo ngomphumela onembile ngezinyathelo ezintathu.
Kwangathi ungajabula unyaka omusha kanye nonyaka wengwe egcwele injabulo.
Isikhathi sokuthunyelwe: Agasti-01-2022