Inganda za IVD zirashobora kugabanywamo ibice bitanu: gusuzuma ibinyabuzima, gusuzuma immunodiagnose, gupima selile yamaraso, gusuzuma molekile, na POCT.
1. Gusuzuma ibinyabuzima
1.1 Ibisobanuro no gushyira mu byiciro
Ibicuruzwa bya biohimiki bikoreshwa muri sisitemu yo gutahura igizwe nisesengura ryibinyabuzima, reagent ya biohimiki, na kalibatori.Mubisanzwe bashyirwa muri laboratoire yibitaro no mubizamini byumubiri kugirango basuzume ibinyabuzima bisanzwe.
1.2 Ibyiciro bya sisitemu
2. Gukingira indwara
2.1 Ibisobanuro no gutondekanya
Ubuvuzi bwa immunodiagnose burimo chemiluminescence, immunoassay ifitanye isano na enzyme, zahabu ya colloidal, immunoturbidimetric na latex ibintu bya biohimiki, abasesengura poroteyine zidasanzwe, nibindi. Ubudahangarwa bw’amavuriro busanzwe bwerekeza kuri chemiluminescence.
Sisitemu isesengura chemiluminescence nuburyo butatu buhuza reagent, ibikoresho nuburyo bwo gusesengura.Kugeza ubu, ubucuruzi n’inganda zisesengura chemiluminescence immunoassay zisesengura ku isoko zashyizwe mu byiciro hakurikijwe urwego rwo kwikora, kandi zishobora kugabanywa mu buryo bwikora (plaque yo mu bwoko bwa luminescence enzyme immunoassay) kandi byikora byuzuye (tube type luminescence).
2.2 Igikorwa cyo kwerekana
Chemiluminescence ikoreshwa cyane cyane mugutahura ibibyimba, imikorere ya tiroyide, imisemburo, n'indwara zanduza.Ibi bizamini bisanzwe bingana na 60% byagaciro kisoko hamwe na 75% -80% yubunini bwikizamini.
Noneho, ibizamini bingana na 80% byumugabane wisoko.Ubugari bwokoreshwa mubipaki bimwe bifitanye isano nibiranga, nko kunywa ibiyobyabwenge no gupima ibiyobyabwenge, bikoreshwa cyane muburayi no muri Amerika, kandi ugereranije ni bike.
3. Isoko ry'amaraso
3.1 Ibisobanuro
Ibicuruzwa bibara amaraso bigizwe nisesengura ryamaraso, reagents, kalibatori nibicuruzwa bigenzura ubuziranenge.Isesengura rya Hematology ryitwa kandi isesengura rya hematologiya, ibikoresho by'amaraso, konte y'amaraso, n'ibindi. Ni kimwe mu bikoresho bikoreshwa cyane mu gupima amavuriro miliyoni 100.
Isesengura ry'amaraso rishyira mu byiciro ingirabuzimafatizo z'amaraso yera, selile zitukura, na platine mu maraso hakoreshejwe uburyo bwo kurwanya amashanyarazi, kandi irashobora kubona amakuru ajyanye n'amaraso nko kwibanda kwa hemoglobine, hematocrit, hamwe n'ikigereranyo cya buri kintu kigize selile.
Mu myaka ya za 1960, kubara ingirabuzimafatizo z'amaraso byagezweho binyuze mu gusiga intoki no kubara, byari bigoye mu mikorere, bike mu mikorere, bikennye neza mu gutahura neza, ibipimo bike byo gusesengura, n'ibisabwa byinshi ku bakora imyitozo.Ingaruka zitandukanye zabujije ikoreshwa ryazo mu rwego rwo gupima amavuriro.
Mu 1958, Kurt yashyizeho uburyo bworoshye bwo gukora ingirabuzimafatizo y'amaraso ihuza imbaraga zo kurwanya ikoranabuhanga.
3.2 Ibyiciro
3.3 Icyerekezo cyiterambere
Ikoranabuhanga rya selile yamaraso ni ihame ryibanze rya cytometrike, ariko ibisabwa kugirango imikorere ya cytometrike ikorwe neza, kandi ikoreshwa cyane muri laboratoire nkibikoresho byubushakashatsi bwa siyansi.Hariho ibitaro binini byo murwego rwohejuru bikoresha flux cytometrie mumavuriro kugirango isesengure ibintu byakozwe mumaraso kugirango isuzume indwara zamaraso.Ikizamini cyamaraso kizatera imbere muburyo bwikora kandi bwuzuye.
Byongeye kandi, ibintu bimwe na bimwe byo gupima ibinyabuzima, nka CRP, glycosylated hemoglobine n'ibindi bintu, byahujwe no gupima amaraso mu myaka ibiri ishize.Umuyoboro umwe w'amaraso urashobora kurangira.Ntibikenewe ko ukoresha serumu mugupima ibinyabuzima.Gusa CRP ni ikintu kimwe, giteganijwe kuzana miliyari 10 z'isoko.
4.1 Intangiriro
Isuzuma rya molekuline ryabaye ahantu hashyushye mumyaka yashize, ariko ikoreshwa ryamavuriro riracyafite aho rigarukira.Kwipimisha kwa molekulari bivuga gukoresha tekinoroji ya biologiya ya molekuline kugirango hamenyekane poroteyine zubaka ziterwa n'indwara, enzymes, antigene na antibodies, hamwe na molekile zitandukanye zikora ubudahangarwa, hamwe na gen zigizwe na molekile.Ukurikije uburyo butandukanye bwo gutahura, bushobora kugabanywa mu kuvanga ibaruramari, kongera ingufu za PCR, chip ya gene, ikurikiranwa rya gene, mass spectrometrie, n'ibindi. Kugeza ubu, isuzuma rya molekile ryakoreshejwe cyane mu ndwara zandura, gusuzuma amaraso, gusuzuma hakiri kare, kuvura umuntu ku giti cye, indwara zikomoka ku ngirabuzima fatizo, kwisuzumisha mbere yo kubyara, kwandika tissue hamwe nizindi nzego.
4.2 Ibyiciro
4.3 Gusaba isoko
Isuzuma rya molekuline rikoreshwa cyane mu ndwara zandura, gusuzuma amaraso no mu zindi nzego.Hamwe niterambere ryimibereho yabantu, hazarushaho kumenyekana no gukenera kwisuzumisha.Iterambere ry’inganda n’ubuvuzi n’ubuzima ntirigarukira gusa ku gusuzuma no kuvura, ahubwo rigera no gukumira imiti y’imibonano mpuzabitsina.Hamwe no gusobanura ikarita ya gene yumuntu, isuzuma rya molekile rifite amahirwe menshi yo kuvura umuntu ku giti cye ndetse no kurya byinshi.Isuzuma rya molekuline ryuzuyemo ibishoboka bitandukanye mugihe kizaza, ariko tugomba kuba maso kubyinshi byo gusuzuma no kuvura neza.
Nka tekinoroji igezweho, gusuzuma molekile byagize uruhare runini mugupima ubuvuzi.Kugeza ubu, uburyo nyamukuru bwo gusuzuma indwara ya molekile mu gihugu cyanjye ni ukumenya indwara zandura, nka HPV, HBV, HCV, VIH n'ibindi.Porogaramu yo gusuzuma mbere yo kubyara nayo irakuze cyane, nka BGI, Berry na Kang, nibindi, kumenya ADN yubusa mumaraso ya peripheri y'inda byasimbuye buhoro buhoro tekinike ya amniocentez.
5.POCT
5.1 Ibisobanuro no gushyira mu byiciro
POCT bivuga tekinike yo gusesengura aho abatari abanyamwuga bakoresha ibikoresho byimuka kugirango basesengure vuba ingero zabarwayi kandi babone ibisubizo byiza kumurwayi.
Bitewe nuburyo butandukanye muburyo bwo kugerageza uburyo, hariho uburyo bwinshi bwibintu byahurijwe hamwe, urutonde rwerekana biragoye kubisobanura, ibisubizo byo gupima biragoye kubyemeza, kandi inganda ntizifite ibipimo ngenderwaho bigenzura ubuziranenge, kandi bizakomeza akajagari kandi karatatanye igihe kirekire.Hifashishijwe amateka yiterambere rya POCT igihangange mpuzamahanga Alere, M&A kwishyira hamwe muruganda nicyitegererezo cyiterambere.
5.2 Ibikoresho bisanzwe bikoreshwa muri POCT
1. Gerageza vuba metero glucose yamaraso
2. Isesengura ryihuta ryamaraso
Igihe cyo kohereza: Mutarama-23-2021