Siqinisekisa kanjani ikhwalithi enhle kakhulu yezinto ezisetshenziswayo zaselabhorethri ye-IVD?

Siqinisekisa kanjani ikhwalithi enhle kakhulu yezinto ezisetshenziswayo zaselabhorethri ye-IVD?

I-Suzhou Ace Biomedicaluyazi ukuthi ikhwalithi ibalulekile emkhakheni we-IVD. Izinto ezisetshenziswayo zaselabhorethri yethu, ezithintana ngokuqondile namasampula esiguli nama-reagents, zinomthelela oqondile ekunembeni nasekuthembekeni kokuhlolwa. Ngakho-ke, siyaziqhenya ukumemezela ukuthi izinto zethu ezisetshenziswa kulabhorethri ye-IVD sezifinyelele emazingeni aphezulu kakhulu embonini ngokwekhwalithi.

Siyaqonda ukuthi ukuqinisekiswa kwekhwalithi kuvela ekulawuleni okuqinile kwenqubo ngayinye yokukhiqiza. Yingakho sisebenzisa imigqa yokukhiqiza ezenzakalelayo ngokugcwele futhi silandela ngokuqinile isistimu yokuphatha ikhwalithi ye-ISO13484. Ngokusebenzisa amathuluzi asezingeni eliphezulu kakhulu angenisiwe kanye nezinto zokusetshenziswa, singaqinisekisa ukuthi isinyathelo ngasinye senqubo yokukhiqiza sihlangabezana nezindinganiso eziphakeme kakhulu.

Imikhiqizo yethu ihlanganisa izinto ezisetshenziswayo ezihlukahlukene ezidingekayo kumalabhorethri e-IVD, njengamathiphu e-pipette, amapuleti ajulile, izinto ezisetshenziswayo ze-PCR, namabhodlela e-reagent. Ohlotsheni ngalunye lomkhiqizo, sikhiqiza futhi silawule ikhwalithi yawo ngendlela ehlukile ukuze sihlangabezane nezidingo ezithile zokuhlolwa okuhlukile.

Isibonelo, amathiphu ethu e-pipette enziwe ngezinto eziyingqayizivele futhi aklanyelwe ukuqinisekisa ukudluliswa koketshezi olunembile nokunciphisa amaphutha. Amapuleti omthombo ojulile enziwe ngokuqina nokuzinza okukhethekile ukuze kuqinisekiswe ukwethembeka kwemiphumela yokuhlolwa. Izinto ezisetshenziswayo ze-PCR kukhiqizwa ngaphansi kokulawulwa kwekhwalithi okuqinile ukuze kuqinisekiswe ukunemba nokukhiqizwa kabusha kokusabela kwe-PCR. Futhi amabhodlela ethu e-reagent ayaziwa ngokusebenza kwawo okuhle kakhulu kokuvala nokuzinza, okuqinisekisa ukulondolozwa kwesikhathi eside nokuzinza kwama-reagents.

Izinto ezisetshenziswa kulabhorethri yethu ye-IVD azifinyelelanga nje kuphela izindinganiso eziphakeme kakhulu embonini ngokuya ngekhwalithi kodwa futhi zizuze ukwethenjwa nodumo lwamalabhorethri amaningi emhlabeni wonke ngokusebenza kwawo okuhle kakhulu nokuqina. Sikholelwa ngokuqinile ukuthi ikhwalithi kuphela engazuza ukwethenjwa kwamakhasimende futhi uchwepheshe kuphela ongazuza ukuhlonishwa kwemakethe.

Ngokuzayo, sizoqhubeka nokugxila ekuthuthukiseni izinga lomkhiqizo nokusebenza ukuze sihlangabezane nezidingo zemakethe ezithuthukayo zomkhakha we-IVD. Sikholelwa ukuthi kuphela ngokusungula izinto ezintsha kanye nokwenza ngcono lapho singakwazi ukuhlinzeka ngemikhiqizo namasevisi ekhwalithi engcono kakhulu ukuhlangabezana nezidingo zamakhasimende kanye nokulindelweyo.

Ekugcineni, iSuzhou Ace Biomedical ithanda ukubonga wonke amakhasimende ethu ngokusikhetha nokusisekela. Ukwethenjwa kwakho nokwesekwa kwakho okusinika ugqozi lokuqhubeka sithuthukisa ikhwalithi yomkhiqizo nokusebenza futhi sibe negalelo elikhulu ekuthuthukisweni kwemboni ye-IVD.

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Isikhathi sokuthumela: Nov-02-2023