Ikhithi ye-RT-PCR ye-fluorescent yexesha langempela yokufumanisa i-SARS-CoV-2
Igama lemveliso
Ikhithi ye-HWTS-RT057A-yexesha langempela ye-RT-PCR ekhanyayo yokufumanisa i-SARS-CoV-2
Ikhithi ye-RT-PCR ye-HWTS-RT057F-eyomileyo eqandisiweyo ye-Real-time fluorescent yokufumanisa i-SARS-CoV-2 -Subpackage
Isatifikethi
CE
I-Epidemiology
I-coronavirus entsha (SARS-CoV-2) isasazeke kwihlabathi liphela ngokubanzi. Kwinkqubo yokusasazeka, utshintsho olutsha luhlala lusenzeka, nto leyo ebangela iinguqulelo ezintsha. Le mveliso isetyenziselwa ikakhulu ukufumanisa kunye nokwahlula amatyala anxulumene nosulelo emva kokusasazeka okukhulu kweentlobo ze-mutant ze-Alpha, Beta, Gamma, Delta kunye ne-Omicron ukususela ngoDisemba 2020.
Itshaneli
| I-FAM | I-2019-nCoV ORF1ab gene |
| CY5 | I-2019-nCoV N gene |
| I-VIC(HEX) | i-gene yesalathiso sangaphakathi |
Iiparameters zobugcisa
| Indawo yokugcina izinto | Ulwelo: ≤-18℃ Ebumnyameni |
| I-Lyophilized: ≤30℃ Ebumnyameni | |
| Beka ubomi kwishelufa | Ulwelo: Iinyanga ezili-9 |
| I-Lyophilized: iinyanga ezili-12 | |
| Uhlobo lweSibonelelo | iiswabhu ze-nasopharyngeal, iiswabhu ze-oropharyngeal |
| CV | ≤5.0% |
| Ct | ≤38 |
| I-LoD | Iikopi ezingama-300/mL |
| Ukuchaneka | Akukho kudibana kwe-coronavirus yabantu i-SARS-CoV kunye nezinye izifo ezixhaphakileyo. |
| Izixhobo Ezisebenzayo: | Iinkqubo ze-PCR ze-Applied Biosystems 7500 Real-Time Iinkqubo ze-PCR eziSebenzisiweyo ze-7500 ezikhawulezayo zeXesha langempela Iinkqubo ze-PCR ze-SLAN ®-96P zeXesha langempela Iinkqubo ze-PCR zeQuantStudio™ ezi-5 zeXesha langempela Inkqubo ye-PCR yeLightCycler®480 yeXesha langempela Inkqubo yokuHlola i-PCR yeLineGene 9600 Plus ngexesha langempela I-MA-6000 Real-Time Quantitative Thermal Cycler Inkqubo ye-PCR ye-BioRad CFX96 yeXesha langempela Inkqubo ye-PCR ye-BioRad CFX Opus 96 yeXesha langempela |
Ukuhamba komsebenzi
Ukhetho 1.
Ikhithi yokuKhupha okanye yokuHlambulula i-Nucleic Acid (iNdlela yeeBeads zeMagnetic) (i-HWTS-3001, i-HWTS-3004-32, i-HWTS-3004-48) evela kwiJiangsu Macro kunye neMicro-Test Med-Tech Co., Ltd.
Ukhetho 2.
I-reagent yokukhupha ecetyiswayo: I-QIAamp Viral RNA Mini Kit (52904), i-Viral RNA Extraction Kit (YDP315-R) eyenziwe yiTiangen Biotech (Beijing) Co., Ltd.
