Iimveliso ezintlanu zeMacro kunye neMicro-Test ezivunyiweyo yi-US FDA

Ngomhla wama-30 kweyoMqungu kunye nomsitho woNyaka oMtsha waseTshayina, iimveliso ezintlanu ezenziwe yiMacro & Micro-Test, iEasy Amp Real-time Fluorescence Isothermal Detection System, iMicro-Test Automatic Nucleic Acid Extractor, iMacro & Micro-Test Viral DNA/RNA Kit, iMacro & Micro-Test Sample Release Reagent, kunye neMacro & Micro-Test Sample Collecting, Mailing & Shipping Kit zivunyiwe kwaye zavunywa yi-US FDA ngokwahlukeneyo.

Uvavanyo lweMacro kunye neMicro
Uvavanyo lweMacro kunye neMicro1
Uvavanyo lweMacro kunye neMicro2

Ukutya, amayeza, izinto zokuthambisa kunye nezixhobo zonyango ezivunyiweyo yi-US Food and Drug Administration (FDA), eyaziwayo kwihlabathi liphela njengegunya lokwamkelwa kwezixhobo zonyango, ziimveliso eziphandwe kwaye zigunyaziswe yimigangatho egunyazisiweyo yehlabathi. Ezi mveliso zintlanu zigunyazisiweyo yi-FDA ezivela kwi-Macro & Micro-Test zigubungela yonke inkqubo yovavanyo lwe-nucleic.

 

1. Ukuthatha iisampulu

Uvavanyo lweMacro kunye neMicro3

Ubungakanani obuhlukeneyo bubini, i-swab eqhekezwayo enokuqhekezwa jikelele, ukungasebenzi kweentsholongwane okusebenzayo, okusebenzayo ekufumaneni okuxutyiweyo.

2. Ukutsalwa kweNucleic Acid
● Inkqubo A

Uvavanyo lweMacro kunye neMicro4

Ikhithi ye-DNA/RNA yeViral Viral yeMacro kunye neMicro-Test
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I-Automatic Nucleic Acid Extractor

I-Automatic Nucleic Acid Extractor isebenza ngomzantsi omnye kuphela, ikhulula izandla zabasebenzi bezonyango. Nge-Macro & Micro-Test Viral DNA/RNA Kit, inkqubo yokukhupha i-nucleic acid inokugqitywa.kwimizuzu eli-10, ikhawulezisa kakhulu umsebenzi kwaye inciphisa umthwalo kwiilabhoratri.

● Inkqubo B

Uvavanyo lweMacro kunye neMicro5

I-Reagent yoKhupho lweSampuli yeMacro kunye neMicro-Test

Ukusasazeka kweNtsholongwane yeSARS-CoV-2 kuzise uxinzelelo olukhulu kubasebenzi bezonyango nakwiilabhoratri, abanobunzima bokwenza uvavanyo oluphezulu oluthintelwe yindawo, ixesha, izixhobo kunye nabasebenzi. Ukuqwalasela oku, iMacro kunye neMicro-Test zenze isisombululo sokukhulisa ngokuthe ngqo senyathelo elinye:ukukhupha isampuli kwimizuzu emi-5 ngaphandle koncedo lwesixhobo.

3. Ukwandiswa kwe-Isothermal

Uvavanyo lweMacro kunye neMicro7

Xa kuthelekiswa novavanyo lwePCR lwendabuko, i-Easy Amp Real-time Fluorescence Isothermal Detection System, eneziphumo ezilungileyo.kwimizuzu emi-5, inciphise yonke inkqubo yokufumanisa nge-2/3. Iimodyuli zayo ze-4x4 ezizimeleyo ziqinisekisa uvavanyo olufunekayo ngeziphumo ezichanekileyo ngamanyathelo amathathu.

Ngamana unyaka omtsha omnandi kunye nonyaka wengwe ozele lulonwabo.


Ixesha lokuthumela: Agasti-01-2022