5 Amanqaku malunga ne-Alere Aqinisekise ukuhlolwa kwe-HIV Combo Test

Uvavanyo lwesizukulwana sesi-4 Phakathi kweenketho ezikhethwa yiCDC

Xa i-US Food and Drug Administration ivumile ukuba i-Alere iqinisekise uvavanyo lwe-HIV-1/2 Ag / Ab Combo ngo-Agasti 9, 2013, yamkelwa ngokubanzi ngababoneleli bezempilo kunye nabenzi bomgaqo-nkqubo ngokufanayo. Kwakungekho loo nto eyayingekho izixhobo zokunakekelwa ezifumanekayo ukuvavanya i-HIV-1 okanye i-HIV-2, okanye ezo zinokuzibona ngokwahlukileyo i-antigen okanye i-antibodies.

Ngaphandle kokulungelelanisa kweso sicelo sonke-in-one, i-Alere Determine Combo yimihlo kunye namagxa angaphezu kweemvavanyo zenzalo zangaphambili, zinikeza amazinga aphezulu obuzwe, ubuchule kunye nesantya.

Ezi mpu melelo ziba namhlanje phakathi kweesilingo ezimbini (kunye ne-Abbott ARCHITECT ye-HIV Ag / Ab Combo) ecetyiswa ngamaZiko okuLawula nokuKhuselwa kwezifo njengendlela yokukhetha i-HIV kwi-US.

Nazi izinto ezi-5 omele wazi ngazo nge-Alere Determine Combo:

1. I-Determine Combo ayilona vavanyo lwe-HIV elingaphezu kwe-HIV.

Ngokungafani ne-OraQuick In-Home Test Oral Test, i-Determine Combo yinto elula yokuhlolwa kwegazi elawulwa kuphela kwiindawo zokuvavanya ezifanelekileyo.Nakuba i-OraQuick inokunika iimvavanyo zangasese eziyimfihlo ngexesha elingama-20 engama- izinga elibi le-15% (okanye malunga novavanyo olulodwa).

Ngokwahlukileyo, ukufundiswa okungekho nkohliso kunye neC Determine Combo kuthathwa njengabunqabileyo kunye novelwano lwama-100 ekhulwini.

2. Ukuvavanya i-antigens ye-HIV ngokukhawuleza kunokukhawuleza kunokuvavanya ama-antibodies.

I-Antigens zizinto zangaphandle ezenza umzimba uvelise ama-antibodies omzimba.

Ngoko ke, njengommiselo, uvavanyo olukhawulezayo lwe-antigen anikezela ngokukhawuleza iziphumo kunokuhlolwa kwe-antibody. Kwimeko yokuQinisekisa iCombo, sithetha iziphumo kwiintsuku ezili-12 ukuya kwezingama-26 ngokumalunga neentsuku ezingama-20 ukuya kwi-45 zokuvavanywa kwe-antibody based based test.

3. Iimvavanyo ze-Determine Combo zangoku kuphela ze-antigens ze-HIV-1, kungekhona ii-antigens ze-HIV-2.

Akunakucacisa phakathi kwe-HIV-1 kunye ne-HIV-2 antibodies.

Konke oku kuthetha ukuba abo banesifo sosulelo lwe-HIV-2 (efunyenwe ikakhulukazi eNtshona Afrika) banokuba neemeko ezincinci kakhulu zeziphumo zokuvavanya.

4. Nangona iCermermine Combo ichanekile, akuyiyo ukuhlolwa kokugqibela.

Nangona umntu evavanya kakuhle kwii-antigen ze-HIV kunye ne-antibodies, i-HIV-1 test nucleic acid (NAT) isadingeka yenziwe. I-NAT ye-HIV-1 iyakwazi ukubona i-RNA enegciwane elinamazinga aphezulu okuchaneka kwiintsuku ezi-1-2, emva kokusuleleka.

5. I-Detemine Combo iyancipha ngexesha lokusuleleka.

Nangona ulwaphulo lwe-antigen lwama-86% kuphela, udibaniso lwe-antibody / test antigen luyandisa ubuninzi bokuba ngaphezu kwe-99%, oku ngokuhambelana nokulungiswa kwenkqubo ekhutshwe yi-CDC.

Nangona kunjalo, akuzange kwenzeke nakwabantu abaneentsholongwane zentsholongwane. Ngokomphando ovela kwiYunivesithi yaseCalifornia, iSan Francisco, iCermermine Combo yayikwazi ukuchonga isiqingatha sezifo ezikhuselekileyo kwaye ngokuqhelekileyo zenze njalo xa umthamo wegciwane lesigulane ungaphezulu kwama-500,000 ikopi / mL.

Ngokwahlukileyo, uvavanyo lwe - ARCHITECT olusekelwe ebhanini olusebenzayo lwe-antigen / anti-antibody luyenze okusemgangathweni kwamalinge okufumaneka. Ngomlinganiselo oqikelelweyo phakathi kwe-99.1% kunye ne-100%, iimvavanyo zazikwazi ukuchonga malunga ne-90% yezifo ezikhuselekileyo.

ILizwi

Ukhetho lweemvavanyo ze-HIV lunokuba lukhulu kakhulu, kunye nabanye abantu abazondayo inaliti, abanye bafuna ukukhawuleza, kunye nabanye basesaba ukukhutshwa koluntu. Nangona i-Alere Ikhetha iCombo kunye ne-Abbott ARCHITECT zizo zombini ezikhethiweyo zokukhetha, okungafanelekanga ukuba zifune ezinye iindidi zeemvavanyo ukuba ufuna iimfihlo okanye ukhethe uvavanyo lwama-saliva ekuhlolweni kwegazi.

Ukuba uxhalabele ngemfihlo, biza ikliniki yakho yangasese kwaye ubuze ukuba banikezela ukuvavanya okanye okungaziwa . Kuzo naziphi na, qaphela ukuba kukho imithetho ekhoyo ukuqinisekisa ukuba ulwazi malunga novavanyo lwakho lwe-HIV alukwazi ukukhutshwa ngaphandle kwemvume yakho.

Ngaphambi kokuba wenze i-aphoyintimenti, cela iklinikhi malunga nemigaqo-nkqubo yabucala kunye nendlela abagcina ngayo imfihlo kwisayithi . Unokuqhagamshelana nomnxeba wakho we- HIV okanye ubiza i-800-CDC-INFO (800-232-4636) ukuba ubone ukuba kukho naziphi na izitifiketi ezingavumelekanga kwindawo yakho.

Into ephambili kukuba uhlolwe kwaye udibaniswe nokunyamekela kunye nenkxaso oyifunayo ukuba ufumene i-diagnostic.

> Imithombo:

> Ulawulo lweZiko lokuTya kunye neDrug (FDA). "I-FDA iyavuma okokuqala ukuxilonga ngokukhawuleza ukufumana i-HIV-1 antigen kunye ne-HIV-1/2 antibodies." Silver Spring, eMaryn; ukukhutshwa kwenkcazelo ekhutshwe ngo-Agasti 8, 2013.

> Branson, B; Owen, S; Wesolowski, M .; okqhubekayo. "Uvavanyo lweLebhu yokuHlola iNtsholongwane kaGawulayo: Iingcebiso eziPhuculo." Amaziko e-US for Control and Prevention (CDC) yeZifo. Atlanta, Georgia; kukhutshwa ngoJuni 27, 2014.

> Pilcher, D .; Louie, B; Facente, S .; okqhubekayo. "Ukusebenza kwe-Rapid Point-of-Care kunye neeNzame zeLebhu zeNgcaciso kunye nokuSungulwa koGawulayo eSan Francisco." I-PLOS | Enye. Disemba 12, 2013; INGXELO: 10.1371 / iphephandaba.pone.0080629.

> Isebe Lempilo Neenkonzo Zoluntu (DHHS). "UkuVihlaka kunye noNgenamava ongaziwayo." HIV.gov; hlaziywa ngoJulayi 5, 2015