Imboni ye-IVD ingahlukaniswa ngezigaba ezinhlanu: ukuxilongwa kwe-biochemical, i-immunodiagnosis, ukuhlolwa kwamangqamuzana egazi, ukuxilongwa kwamangqamuzana, kanye ne-POCT.
1. Ukuxilongwa kwamakhemikhali ezinto eziphilayo
1.1 Incazelo kanye nezigaba
Imikhiqizo yamakhemikhali ezinto eziphilayo isetshenziswa ohlelweni lokuhlonza olwakhiwe abahlaziyi be-biochemical, ama-biochemical reagents, nama-calibrators.Ngokuvamile zifakwa elabhorethri yasesibhedlela nasezikhungweni zokuhlola umzimba ukuze kuhlolwe amakhemikhali ezinto eziphilayo.
1.2 Ukuhlukaniswa kwesistimu
2. I-Immunodiagnosis
2.1 Incazelo kanye nezigaba
I-Clinical immunodiagnosis ihlanganisa i-chemiluminescence, i-enzyme-linked immunoassay, igolide le-colloidal, i-immunoturbidimetric kanye nezinto ze-latex ku-biochemistry, abahlaziyi bamaprotheni abakhethekile, njll. Ukungavikeleki komtholampilo okuncane ngokuvamile kubhekisela ku-chemiluminescence.
Uhlelo lwe-chemiluminescence analyzer luyinhlanganisela ka-trinity yama-reagents, izinsimbi nezindlela zokuhlaziya.Njengamanje, ukuthengiswa kanye nokwenza izimboni kwabahlaziyi be-chemiluminescence immunoassay emakethe kuhlukaniswa ngokwezinga lokuzenzakalelayo, futhi kungahlukaniswa nge-semi-automatic (i-plate type luminescence enzyme immunoassay) kanye ne-othomathikhi ngokugcwele (i-tube type luminescence).
2.2 Umsebenzi wokubonisa
I-Chemiluminescence okwamanje isetshenziselwa kakhulu ukuthola izimila, umsebenzi wegilo, amahomoni, nezifo ezithathelwanayo.Lezi zivivinyo ezijwayelekile zibalelwa ku-60% yenani eliphelele lemakethe kanye no-75% -80% wevolumu yokuhlola.
Manje, lezi zivivinyo zibalelwa ku-80% wesabelo semakethe.Ububanzi bokusetshenziswa kwamaphakheji athile buhlobene nezici, ezifana nokusebenzisa kabi izidakamizwa nokuhlolwa kwezidakamizwa, ezisetshenziswa kakhulu eYurophu nase-United States, futhi ezimbalwa uma kuqhathaniswa.
3. Imakethe yamaseli egazi
3.1 Incazelo
Umkhiqizo wokubala amangqamuzana egazi unomshini wokuhlaziya amangqamuzana egazi, ama-reagents, ama-calibrator kanye nemikhiqizo yokulawula ikhwalithi.I-hematology analyzer ibizwa nangokuthi i-hematology analyzer, ithuluzi lamaseli egazi, isibali samaseli egazi, njll. Ingenye yamathuluzi asetshenziswa kakhulu ekuhloleni umtholampilo wezigidi ezingu-RMB eziyi-100.
Umhlaziyi wamaseli egazi uhlukanisa amangqamuzana egazi amhlophe, amangqamuzana egazi abomvu, namaplatelet egazini ngendlela yokumelana nogesi, futhi angathola idatha ehlobene negazi njengokugxila kwe-hemoglobin, i-hematocrit, kanye nesilinganiso sengxenye yeseli ngayinye.
Ngawo-1960, ukubalwa kwamangqamuzana egazi kwafinyelelwa ngokusebenzisa ukungcoliswa nokubala okwenziwa ngesandla, okwakuyinkimbinkimbi ekusebenzeni, ukusebenza kahle okuphansi, ukunemba ekutholeni ukunemba, imingcele yokuhlaziya embalwa, kanye nezidingo eziphezulu zabasebenzi.Ukungalungi okuhlukahlukene kukhawulele ukusetshenziswa kwayo emkhakheni wokuhlolwa komtholampilo.
Ngo-1958, u-Kurt wenza ikhawunta yamangqamuzana egazi esebenza kalula ngokuhlanganisa ukumelana nobuchwepheshe be-elekthronikhi.
3.2 Ukuhlelwa
3.3 Indlela yentuthuko
Ubuchwepheshe bamangqamuzana egazi buyafana nesimiso esiyisisekelo sokugeleza kwe-cytometry, kodwa izidingo zokusebenza ze-cytometry yokugeleza zicwengisiswe kakhulu, futhi isetshenziswa kabanzi kumalabhorethri njengamathuluzi ocwaningo lwesayensi.Sekuvele kunezibhedlela ezinkulu ezisezingeni eliphezulu ezisebenzisa i-flow cytometry emitholampilo ukuze zihlaziye izakhi ezakhiwe egazini ukuze kuhlolwe izifo zegazi.Ukuhlolwa kwamangqamuzana egazi kuzothuthuka ngendlela ezenzakalelayo futhi edidiyelwe.
Ngaphezu kwalokho, ezinye izinto zokuhlola amakhemikhali ezinto eziphilayo, njenge-CRP, i-glycosylated hemoglobin nezinye izinto, zihlanganiswe nokuhlolwa kwamangqamuzana egazi eminyakeni emibili edlule.Ishubhu elilodwa legazi lingaqedwa.Asikho isidingo sokusebenzisa i-serum ukuhlola i-biochemical.I-CRP kuphela into eyodwa, okulindeleke ukuthi ilethe indawo yemakethe eyizigidigidi eziyi-10.
4.1 Isingeniso
Ukuxilongwa kwamangqamuzana bekuyinsakavukela umchilo wesidwaba eminyakeni yamuva nje, kodwa ukusebenza kwawo emtholampilo kusenemikhawulo.Ukuxilongwa kwamangqamuzana kubhekisela ekusetshenzisweni kwamasu ebhayoloji yamangqamuzana ekutholeni amaprotheni esakhiwo ahlobene nesifo, ama-enzyme, ama-antigen namasosha omzimba, nama-molecule ahlukahlukene asebenza ngokuzivikela komzimba, kanye nezakhi zofuzo ezihlanganisa la mamolekyuli.Ngokwamasu ahlukene okubona, ingahlukaniswa ibe yi-accounting hybridization, i-PCR amplification, gene chip, gene sequencing, mass spectrometry, njll. Njengamanje, ukuxilongwa kwamangqamuzana sekusetshenziswe kabanzi ezifweni ezithathelwanayo, ukuhlolwa kwegazi, ukuxilongwa kusenesikhathi, ukwelashwa komuntu siqu, izifo zofuzo, ukuxilongwa ngaphambi kokubeletha, ukuthayipha kwezicubu neminye imikhakha.
4.2 Ukuhlelwa
4.3 Isicelo Semakethe
Ukuxilongwa kwamangqamuzana kusetshenziswa kakhulu ezifweni ezithathelwanayo, ukuhlolwa kwegazi neminye imikhakha.Ngokuthuthuka kwamazinga okuphila kwabantu, kuzoba nokuqwashisa okwengeziwe kanye nesidingo sokuxilongwa kwamangqamuzana.Ukuthuthukiswa kwemboni yezokwelapha kanye nezempilo akusagcini ekuxilongweni nasekwelapheni, kodwa kudlulela ekuvimbeleni Umuthi wocansi.Ngokucaciswa kwemephu yofuzo lomuntu, ukuhlonzwa kwamangqamuzana kunethuba elibanzi ekwelashweni komuntu ngamunye kanye nasekusetshenzisweni okukhulu.Ukuxilongwa kwamangqamuzana kugcwele amathuba ahlukahlukene esikhathini esizayo, kodwa kufanele siqaphele ibhamuza lokuxilonga nokwelashwa ngokucophelela.
Njengobuchwepheshe obuphambili, ukuxilongwa kwamangqamuzana kube negalelo elikhulu ekuxilongweni kwezokwelapha.Njengamanje, isicelo esiyinhloko sokuxilongwa kwamangqamuzana ezweni lami ukutholwa kwezifo ezithathelwanayo, njenge-HPV, HBV, HCV, HIV nokunye.Izinhlelo zokusebenza zokuhlolwa ngaphambi kokubeletha nazo sezivuthiwe, njenge-BGI, i-Berry ne-Kang, njll., ukutholwa kwe-DNA yamahhala egazini le-peripheral yengane kancane kancane kuthathe indawo yenqubo ye-amniocentesis.
5.POCT
5.1 Incazelo kanye nezigaba
I-POCT isho indlela yokuhlaziya lapho okungebona ochwepheshe besebenzisa amathuluzi aphathekayo ukuze bahlaziye ngokushesha izifanekiso zesiguli futhi bathole imiphumela engcono esigulini.
Ngenxa yomehluko omkhulu ezindleleni zenkundla yokuhlola, kunezindlela eziningi zezinto zokuhlola ezihlanganisiwe, uhla lwereferensi kunzima ukulichaza, umphumela wokulinganisa kunzima ukuqinisekiswa, futhi imboni ayinawo amazinga afanelekile wokulawula ikhwalithi, futhi izohlala ikhona. isiphithiphithi futhi sahlakazeka isikhathi eside.Ngokuphathelene nomlando wokuthuthukiswa kwe-POCT international giant Alere, ukuhlanganiswa kwe-M&A embonini kuyimodeli yentuthuko ephumelelayo.
5.2 Imishini ye-POCT esetshenziswa kakhulu
1. Hlola ngokushesha imitha yeglucose yegazi
2. Fast blood gas analyzer
Isikhathi sokuthumela: Jan-23-2021