Iintsholongwane Ezintandathu Zokuphefumla Eziyomisiweyo Eziqandisiweyo
Igama lemveliso
I-HWTS-RT177-Isixhobo sokuFumaneka seNucleicAcid esiNqandisiweyo esiNqandisiweyo esiNqandisiweyo (i-Fluorescence PCR)
Ukuvunywa kweMveliso
IVDR
I-Epidemiology
Usulelo lomgudu wokuphefumla lolona hlobo luqhelekileyo lwesifo ebantwini, olunokwenzeka nakweyiphi naisini, ubudala kunye nommandla, kwaye yenye yezona zinto zibalulekileyo zokugula nokufa emhlabeni [1]. Iintsholongwane zokuphefumla eziqhelekileyo ngokwezonyango ziquka intsholongwane yokuphefumla ehambelanayo, i-adenovirus, i-human metapneumovirus, i-rhinovirus, intsholongwane ye-parainfluenza (I/II/III) kunye ne-mycoplasma pneumoniae, njl. [2,3]. Iimpawu zeklinikhi kunye neempawu ezibangelwa lusulelo lwendlela yokuphefumla ziyafana, kodwa usulelo olubangelwa ziintsholongwane ezahlukeneyo luneendlela ezahlukeneyo zonyango, iziphumo zonyango kunye nendlela yesifo [4,5]. Okwangoku, iindlela eziphambili zokufumanisa iintsholongwane zokuphefumla kwilabhoratri ziquka ukwahlulwa kwentsholongwane, ukufunyanwa kwe-antigen kunye nokufunyanwa kwe-nucleic acid, njl. Le khithi ifumanisa kwaye ichonge ii-nucleic acids ezithile zentsholongwane kubantu abaneempawu kunye neempawu zosulelo lokuphefumla, kunye nezinye iziphumo zeklinikhi nezelabhoratri ukunceda ekuchongweni kosulelo lokuphefumla. Iziphumo zolu vavanyo akufuneki zisetyenziswe njengesiseko sodwa sokuxilongwa, unyango, okanye ezinye izigqibo zolawulo lwesigulana.
Iiparameters zobugcisa
| Indawo yokugcina izinto | 2-28℃ |
| Beka ubomi kwishelufa | Iinyanga ezili-12 |
| Uhlobo lweSibonelelo | iswabhu yomlomo womntu, iswabhu yasempumlweni |
| Ct | ≤38 |
| CV | <5.0% |
| I-LoD | Iikopi ezingama-200/mL |
| Ukuchaneka | Ukudibana kwe-Cross-reactivity: Akukho kudibana kwe-kit kunye ne-Human boca virus, i-Cytomegalovirus, i-Herpes simplex virus type 1, i-Varicella zoster virus, i-Epstein-barr virus, i-Bacillus pertussis, i-Chlamydia pneumoniae, i-Corynebacterium, i-Escherichia coli, i-Haemophilus influenzae, i-Lactobacillus, i-Legionella pneumophila, i-Moraxella catarrhalis, Iintlobo ze-Attenuated ze-mycobacterium tuberculosis, i-Neisseria meningitidis, i-Neisseria spp. (Neisseria gonorrhoeae), i-Pseudomonas aeruginosa, i-Staphylococcus aureus, i-Staphylococcus epidermidis, i-Streptococcus pneumoniae, i-IFV A, i-IFV B, i-Parainfluenza IV, i-SARS-CoV-2, i-Coronavirus (HKU1), i-Coronavirus (OC43), i-Coronavirus (NL63). |
| Izixhobo Ezisebenzayo | Uhlobo I: Iinkqubo ze-PCR ze-Applied Biosystems 7500 Real-Time, SLAN-96P Iinkqubo zePCR zeXesha langempela (iHongshi Medical Technology Co., Ltd.). Uvavanyo lohlobo lwesibini: EudemonTM AIO800 (HWTS-EQ007) nguJiangsu Macro kunye Uvavanyo oluNcinci lweMed-Tech Co., Ltd. |
Ukuhamba komsebenzi
Uhlobo I: Kwinkqubo ye-PCR eqhelekileyo
Uhlobo II: Kwi-EudemonTMI-AIO800
IiReagents/Izixhobo ziyafuneka kodwa azibonelelwanga
I-Macro & Micro-Test Viral DNA/RNA Kit (HWTS-3017) (engasetyenziswa kunye ne-Macro & MicroTest Automatic Nucleic Acid Extractor (HWTS-EQ011)) yi-Jiangsu Macro & Micro-Test MedTech Co., Ltd. kunye ne-Macro & Micro-Test Viral DNA/RNA Kit (HWTS-3017-8) (esetyenziswa kunyeI-EudemonTM AIO800) yiJiangsu Macro kunye neMicro-Test Med-Tech Co., Ltd.Isisombululo sokugcina isampuli: Isisombululo se-sodium chloride esingu-0.9%, iKit yeSampling yeVirus (MT0301-1) ngeInkampani yeTekhnoloji yeYocon Biology (eBeijing), i-UTM® Universal Transport Medium™ (iNombolo ye-GXB: 20191277) yiCopan Italia SpA, iSample Collecting, Mailing & Shipping Kit (HWTS-3002) yiJiangsu Macro kunye neMicro-Test Med-Tech Co., Ltd.
Izinto ezisetyenziswayo kufuneka kodwa azibonelelwanga:Iingcebiso ezingenayo i-DNase/RNase, iiglavu ezilahlwayo, ityhubhu ye-DNase/RNase EP, i-Magnetic bead extractor okanye i-magnetic rack.
