Siqinisekisa kanjani ukuthi ikhwalithi enhle kakhulu ye-IVD elebhu?
Suzhou ace biomedicaluyazi ukuthi leyo mfanelo ibalulekile ensimini ye-IVD. Ukudla kwethu kwelebhu, okuthintana ngqo namasampula eziguli nama-reagents, kube nomthelela oqondile ngokunemba nangokuthembeka kokuhlolwa. Ngakho-ke, siyaziqhenya ngokumemezela ukuthi ukudla kwelebhu yethu yelebhu yethu ye-IVD sekufinyelele ezindinganisweni eziphakeme kakhulu embonini ngokuya ngekhwalithi.
Siyaqonda ukuthi isiqinisekiso sekhwalithi sivela ngokulawulwa okuqinile kwenqubo ngayinye yokukhiqiza. Kungakho sisebenzisa imigqa yokukhiqiza ezenzakalelayo ngokuphelele futhi silandele ngokuqinile uhlelo lokuphathwa kwekhwalithi ye-ISO13484. Ngokusebenzisa imishini ethuthukisiwe evezwe kanye nezinto zokwakha ezingavuthiwe, singaqinisekisa ukuthi isinyathelo ngasinye senqubo yokukhiqiza sihlangabezana nezindinganiso eziphakeme kakhulu.
Imikhiqizo yethu ifaka okudliwayo okuhlukahlukene okudingekayo kwama-laboratories e-IVD, njengamathiphu we-PIPETE, amapuleti ajulile, amabhodlela e-PRC, namabhodlela e-realent. Ngohlobo ngalunye lomkhiqizo, sikhiqiza futhi silawule ikhwalithi yalo ngendlela eyingqayizivele yokuhlangabezana nezidingo ezithile zokuhlola okuhlukile.
Isibonelo, amathiphu ethu e-Pipette enziwa ngezinto ezihlukile futhi aklanyelwe ukuqinisekisa ukudluliswa okunembile uketshezi futhi anciphise amaphutha. Amapuleti ajulile akhiwa ngokuqina okuhlukile nokuqina ukuze aqinisekise ukuthembeka kwemiphumela yokuhlola. Ukudla kwe-PRR kukhiqizwa ngaphansi kokulawulwa kwekhwalithi okuqinile ukuqinisekisa ukunemba nokuvela kabusha kokuphendula kwe-PCR. Futhi amabhodlela ethu e-realent ayaziwa ngokusebenza kwawo okuhle kakhulu nokuqina, okuqinisekisa ukulondolozwa kwesikhathi eside nokuqina kwama-reagents.
Ukudla kwethu kwelebhu yethu ye-IVD akukaze kuhlangane namazinga aphezulu kakhulu embonini ngokuya ngekhwalithi kodwa futhi uzuze ukwethenjwa kanye nokudunyiswa kwamalabhoratri amaningi emhlabeni wonke ngokuqina kwawo okuhle nokuqina. Sikholelwa ngokuqinile ukuthi yikhwalithi kuphela engathola ukwethenjwa kwamakhasimende futhi ubungcweti kuphela obunganqoba inhlonipho yemakethe.
Ngokuzayo, sizoqhubeka nokugxila ekwenzeni ngcono ikhwalithi yomkhiqizo nokusebenza ukuze sihlangabezane nezidingo zemakethe ezivelayo zemboni ye-IVD. Sikholwa ukuthi kuphela ngokuqamba okusha okuqhubekayo kanye nokwenza ngcono ukuvumelanisa imikhiqizo esezingeni eliphezulu nezinsizakalo zokuhlangabezana nezidingo zamakhasimende nokulindelwe.
Ekugcineni, iSuzhou ace biomedical ingathanda ukubonga wonke amakhasimende ethu ngokukhetha nokusisekela. Kuyithemba lakho nokusekelwa okusinika isisusa sokuqhubeka nokwenza ngcono ikhwalithi yomkhiqizo nokusebenza futhi kube nomthelela omkhulu ekuthuthukisweni komkhakha we-IVD.
Isikhathi sePosi: Nov-02-2023