Ushishino lwe-IVD lunokwahlulwa lube ngamacandelwana amahlanu: ukuxilongwa kwe-biochemical, i-immunodiagnosis, ukuhlolwa kweeseli zegazi, ukuxilongwa kwe-molecular, kunye ne-POCT.
1. Ukuxilongwa kwe-Biochemical
1.1 Inkcazo nokuhlelwa
Iimveliso ze-Biochemical zisetyenziselwa inkqubo yokufumanisa eyenziwe ngabahlalutyi be-biochemical, ii-reagents ze-biochemical, kunye ne-calibrators. Ngokuqhelekileyo bafakwa kwilabhoratri yasesibhedlele kunye namaziko ovavanyo lomzimba ukwenzela iimviwo zesiqhelo ze-biochemical.
1.2 Ukuhlelwa kwenkqubo
2. Immunodiagnosis
2.1 Inkcazo nokuhlelwa
I-Clinical immunodiagnosis ibandakanya i-chemiluminescence, i-enzyme-linked immunoassay, igolide ye-colloidal, i-immunoturbidimetric kunye nezinto ze-latex kwi-biochemistry, i-protein analyzers ekhethekileyo, njl.
Inkqubo yokuhlalutya i-chemiluminescence yindibaniselwano ye-trinity ye-reagents, izixhobo kunye neendlela zokuhlalutya. Okwangoku, urhwebo kunye noshishino lwe-chemiluminescence immunoassay analyzers kwimarike zihlelwa ngokwenqanaba lokuzisebenzela, kwaye zinokwahlulwa zibe semi-automatic (ipleyiti yohlobo lwe-luminescence enzyme immunoassay) kunye nokuzenzekela ngokupheleleyo (uhlobo lwe-tube luminescence).
2.2 Umsebenzi wokubonisa
I-Chemiluminescence okwangoku isetyenziselwa ukukhangela amathumba, umsebenzi we-thyroid, iihomoni kunye nezifo ezosulelayo. Ezi mvavanyo zesiqhelo zenza i-60% yexabiso lemarike lilonke kunye ne-75% -80% yomthamo wovavanyo.
Ngoku, ezi mvavanyo zibalelwa kwi-80% yesabelo semarike. Ububanzi bokusetyenziswa kweepakethe ezithile bunxulumene neempawu, ezifana nokusetyenziswa kakubi kweziyobisi kunye nokuvavanywa kweziyobisi, ezisetyenziswa kakhulu eYurophu nase-United States, kwaye zimbalwa.
3. Imarike yeeseli zegazi
3.1 Inkcazo
Imveliso yokubala iiseli zegazi iqulethe i-analyzer yegazi, i-reagents, i-calibrator kunye neemveliso zokulawula umgangatho. I-hematology analyzer ikwabizwa ngokuba yi-hematology analyzer, isixhobo seeseli zegazi, ikhawunta yeeseli zegazi, njl.
Umhlalutyi weeseli zegazi uhlela iiseli ezimhlophe zegazi, iiseli ezibomvu zegazi, kunye neeplatelet egazini ngendlela yokumelana nombane, kwaye unokufumana idatha enxulumene negazi efana noxinaniso lwe-hemoglobin, i-hematocrit, kunye nomlinganiselo wecandelo ngalinye leseli.
Ngeminyaka yee-1960, ukubalwa kweeseli zegazi kwaphunyezwa ngokucocwa ngesandla kunye nokubala, okwakunzima ekusebenzeni, ukusebenza okuphantsi, ukungahambi kakuhle ekuboneni ukuchaneka, iiparitha ezimbalwa zokuhlalutya, kunye neemfuno eziphezulu zabasebenzi. Ukungalungi okuhlukeneyo kuthintele ukusetyenziswa kwayo kwinkalo yovavanyo lweklinikhi.
Ngowe-1958, uKurt wavelisa ikhawuntari yeeseli zegazi ekulula ukuyisebenzisa ngokudibanisa ukumelana nobuchwepheshe be-elektroniki.
3.2 Ukuhlelwa
3.3 Indlela yophuhliso
Itekhnoloji yeeseli zegazi iyafana nomgaqo osisiseko wokuhamba kwe-cytometry, kodwa iimfuno zokusebenza kwe-flow cytometry zicokiswa ngakumbi, kwaye zisetyenziswa ngokubanzi kwiilabhoratri njengezixhobo zophando lwezenzululwazi. Sele kukho izibhedlele ezinkulu eziphezulu ezisebenzisa i-flow cytometry kwiiklinikhi ukuhlalutya izinto ezibunjiweyo egazini ukuxilonga izifo zegazi. Uvavanyo lweeseli zegazi luya kuphuhliswa kwindlela ezenzekelayo kunye nedibeneyo.
Ukongeza, ezinye izinto zovavanyo lwe-biochemical, njenge-CRP, i-glycosylated hemoglobin kunye nezinye izinto, ziye zahlanganiswa kunye novavanyo lweeseli zegazi kule minyaka mibini idlulileyo. Umbhobho wegazi omnye unokuzaliswa. Akukho mfuneko yokusebenzisa i-serum kuvavanyo lwe-biochemical. Kuphela i-CRP yinto enye, ekulindeleke ukuba izise i-10 yeebhiliyoni zendawo yemarike.
4.1 Intshayelelo
Ukuxilongwa kwe-molekyuli ibe yindawo eshushu kwiminyaka yakutshanje, kodwa ukusetyenziswa kwayo kweklinikhi kusenemida. Ukuxilongwa kweemolekyuli kubhekiselele ekusetyenzisweni kobuchule bebhayoloji yemolekyuli ekubhaqweni kweeprotheyini zesakhiwo ezinxulumene nesifo, ii-enzymes, ii-antigens kunye ne-antibodies, kunye neemolekyuli ezahlukeneyo ze-immunologically ezisebenzayo, kunye nofuzo olufaka ezi molekyuli. Ngokweendlela ezahlukeneyo zokufumanisa, zinokwahlulwa zibe yi-accounting hybridization, i-PCR amplification, i-gene chip, i-gene sequencing, i-mass spectrometry, njl. Okwangoku, ukuxilongwa kwee-molecular kusetyenziswe ngokubanzi kwizifo ezithathelwanayo, ukuhlolwa kwegazi, ukuxilongwa kwangaphambili, unyango lomntu siqu, izifo zemfuzo, ukuxilongwa kwangaphambi kokubeleka, ukuchwetheza kwezicubu kunye neminye imimandla.
4.2 Ukuhlelwa
4.3 Isicelo seMarike
Ukuxilongwa kwe-molecular kusetyenziswa ngokubanzi kwizifo ezithathelwanayo, ukuhlolwa kwegazi kunye nezinye iinkalo. Ngokuphuculwa kwemigangatho yokuphila kwabantu, kuya kubakho ukuqonda ngakumbi kunye nemfuno yokuxilongwa kweemolekyuli. Uphuhliso lweshishini lezonyango kunye nezempilo alusekho kuphela kuxilongo kunye nonyango, kodwa ludlulela ekuthinteleni Iyeza lezesondo. Ngokucaciswa kwemephu yemfuza yomntu, ukuxilongwa kweemolekyuli kunamathuba abanzi kunyango lomntu ngamnye kunye nokusetyenziswa okukhulu. Ukuxilongwa kweemolekyuli kugcwele ngamathuba ahlukeneyo kwixesha elizayo, kodwa kufuneka silumkele iqamza lokuxilongwa ngononophelo kunye nonyango.
Njengobuchwephesha bokusika, ukuxilongwa kweemolekyuli kuye kwenza igalelo elikhulu ekuxilongweni kwezonyango. Okwangoku, isicelo esiphambili sokuxilongwa kweemolekyuli kwilizwe lam kukufumanisa izifo ezithathelwanayo, ezifana ne-HPV, i-HBV, i-HCV, i-HIV kunye nokunye. Uvavanyo lwangaphambi kokubeleka lukwakhulile ngokwentelekiso, njenge-BGI, iBerry kunye neKang, njl. njl., ukufunyanwa kwe-DNA yasimahla kwigazi lomntwana oselusana kuthathe indawo kancinane ubuchule be-amniocentesis.
5.POCT
5.1 Inkcazo nokuhlelwa
I-POCT ibhekisa kubuchule bokuhlalutya apho abangengabo oochwephesha basebenzisa izixhobo eziphathwayo ukuhlalutya ngokukhawuleza imizekelo yezigulane kwaye bafumane iziphumo ezingcono malunga nesigulane.
Ngenxa yomahluko omkhulu kwiindlela zeqonga lovavanyo, kukho iindlela ezininzi zokuvavanya izinto ezidityanisiweyo, uluhlu lwereferensi kunzima ukulichaza, isiphumo sokulinganisa kunzima ukuqinisekiswa, kwaye ishishini alinayo imigangatho yolawulo lomgangatho efanelekileyo, kwaye iya kuhlala. isiphithiphithi kwaye sachithakala ixesha elide. Ngokubhekiselele kwimbali yophuhliso ye-POCT ye-Alere yamazwe ngamazwe, ukuhlanganiswa kwe-M&A ngaphakathi kushishino ngumzekelo wophuhliso olusebenzayo.
5.2 Izixhobo zePOCT ezisetyenziswa ngokuqhelekileyo
1. Ukuvavanya ngokukhawuleza imitha yeglucose yegazi
2. I-analyzer yegesi ekhawulezayo yegazi
Ixesha lokuposa: Jan-23-2021