Indwara esheshatu zo guhumeka zumye mu buryo bukonjeshejwe, aside nucleic

Ibisobanuro bigufi:

Iki gicuruzwa gikoreshwa mu gupima aside nucleic ya virusi y'ubuhumekero ikoreshwa mu buryo bwa "in vitro qualitative"(RSV), adenovirus (Adv), metapneumovirus y’abantu (hMPV), rhinovirus (Rhv), parainfluenza virus yo mu bwoko bwa I/II/III (PIV I/II/III) na Mycoplasma pneumoniae (MP) mu bipimo bya swab y’umuntu yo mu kanwa n’agapira ko mu nda ku bakekwaho kwandura indwara z’ubuhumekero. Ibisubizo by’ibizamini bizafasha gusuzuma uko RSV, Adv, hMPV, Rhv, PIV, MP yanduye mu buvuzi nk'inkunga mu gusuzuma ubwandu bwa virusi bifitanye isano hamwe n’amateka y’ibyorezo, ibimenyetso by’ubuvuzi n’isuzuma hamwe n’ibindi byavumbuwe muri laboratwari. Ibisubizo by’iki kizamini ntibigomba gukoreshwa nk'ishingiro ryonyine ryo gusuzuma, kuvura, cyangwa ibindi byemezo byo gucunga umurwayi.


Ibisobanuro birambuye ku gicuruzwa

Ibirango by'ibicuruzwa

Izina ry'igicuruzwa

HWTS-RT177-Ifite udukoko dutandatu two guhumeka twa HWTS-RT177 (Fluorescence PCR)

Kwemeza Ibicuruzwa

IVDR

Ubumenyi bw'indwara

Indwara zo mu myanya y'ubuhumekero ni zo ndwara zikunze kugaragara ku bantu, zishobora kubaho muigitsina, imyaka n'akarere, kandi ni imwe mu mpamvu zikomeye zitera indwara n'impfu ku isi [1]. Indwara zikunze kugaragara mu buvuzi zirimo virusi itera ubuhumekero, virusi ya adenovirus, virusi ya pneumovirusi y'abantu, virusi ya rhinovirusi, virusi ya parainfluenza (I/II/III) na mycoplasma pneumoniae, nibindi [2,3]. Ibimenyetso n'ibimenyetso by'indwara ziterwa n'indwara z'ubuhumekero birasa, ariko indwara ziterwa n'indwara zitandukanye zifite uburyo butandukanye bwo kuvura, ingaruka zo kuvura n'uko indwara igenda [4,5]. Kuri ubu, uburyo bw'ingenzi bwo gupima indwara z'ubuhumekero muri laboratwari burimo kwitandukanya na virusi, kumenya antigen no kumenya aside nucleic, nibindi. Iyi kit ipima kandi ikamenya aside nucleic ya virusi ku bantu bafite ibimenyetso n'ibimenyetso by'indwara z'ubuhumekero, hamwe n'ibindi bisubizo by'ubuvuzi na laboratwari kugira ngo bifashe mu gusuzuma indwara z'ubuhumekero. Ibisubizo by'iki kizamini ntibigomba gukoreshwa nk'ishingiro ryonyine ryo gusuzuma, kuvura, cyangwa ibindi byemezo byo gucunga umurwayi.

Ibipimo bya tekiniki

Ububiko 2-28℃
Igihe cyo kumara Amezi 12
Ubwoko bw'ingero agatambaro k'umuhogo w'umuntu, agatambaro ko mu nda
Ct ≤38
CV <5.0%
LoD Kopi 200/mL
Ubwihariye Uburyo bwo kurwanya indwara zitandukanye: Nta buryo bwo kurwanya indwara hagati y’iyi kit na virusi ya boca y’umuntu, virusi ya Cytomegalovirus, virusi ya Herpes simplex type 1, virusi ya Varicella zoster, virusi ya Epstein-barr, Bacillus pertussis, Chlamydia pneumoniae, Corynebacterium, Escherichia coli, Haemophilus influenzae, Lactobacillus, Legionella pneumophila, Moraxella catarrhalis, ubwoko bwa mycobacterium tuberculosis butameze neza, Neisseria meningitidis, Neisseria spp. (Neisseria gonorrhoeae), Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, IFV A, IFV B, Parainfluenza IV, SARS-CoV-2, Coronavirus (HKU1), Coronavirus (OC43), Coronavirus (NL63).
Ibikoresho Bikoreshwa Ubwoko bwa I: Porogaramu za Biosystems 7500 za Mudasobwa za PCR, SLAN-96P

Sisitemu za PCR zikora mu gihe nyacyo (Hongshi Medical Technology Co., Ltd.).

Ikizamini cya II: EudemonTM AIO800 (HWTS-EQ007) cyakozwe na Jiangsu Macro na

Micro-Test Med-Tech Co., Ltd.

Urugendo rw'akazi

Ubwoko bwa I: Kuri sisitemu isanzwe ya PCR

3

Ubwoko bwa kabiri: Kuri EudemonTMAIO800

4

Ibikoresho bitanga umusaruro/Ibikoresho birakenewe ariko ntibitangwa

Kit ya Macro & Micro-Test Viral DNA/RNA (HWTS-3017) (ishobora gukoreshwa hamwe na Macro & MicroTest Automatic Nucleic Acid Extractor (HWTS-EQ011)) na Jiangsu Macro & Micro-Test MedTech Co., Ltd. na Macro & Micro-Test Viral DNA/RNA Kit (HWTS-3017-8) (ikoreshwa hamwe naEudemonTM AIO800) na Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.Icyitegererezo cy'uburyo bwo kubika: 0.9% sodium chloride solution, Virus Sampling Kit (MT0301-1) naIsosiyete ya Yocon Biology Technology (Beijing), UTM® Universal Transport Medium™ (GXB No.: 20191277) na Copan Italia SpA, Icyitegererezo cyo Gukusanya, Kohereza no Kohereza Ingero (HWTS-3002) na Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Ibikoresho bikoreshwa bigomba ariko ntibitangwa:Amabwiriza adafite DNase/RNase, Uturindantoki dukoreshwa mu gusana, umuyoboro wa DNase/RNase EP, Udukoresho two gukuramo udupira twa Magnetic bead cyangwa agakoresho ko gukinga udupira twa magnetic.


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