{"id":32463,"date":"2026-09-29T11:22:04","date_gmt":"2026-09-29T08:22:04","guid":{"rendered":"https:\/\/www.klimikdergisi.org\/?p=32463"},"modified":"2026-09-29T16:33:14","modified_gmt":"2026-09-29T13:33:14","slug":"hiv-tarama-ve-dogrulama-sureci","status":"publish","type":"post","link":"https:\/\/www.klimikdergisi.org\/tr\/2026\/09\/29\/hiv-tarama-ve-dogrulama-sureci\/","title":{"rendered":"\u00dc\u00e7\u00fcnc\u00fc Basamak Bir Merkezde D\u00f6rd\u00fcnc\u00fc Ku\u015fak HIV Tarama ve Do\u011frulama S\u00fcrecinin Sonu\u00e7lar\u0131: 286 425 Hasta \u00d6rne\u011finin De\u011ferlendirilmesi"},"content":{"rendered":"<h2><b>G\u0130R\u0130\u015e<\/b><\/h2>\n<p>\u0130nsan imm\u00fcn yetmezlik virusu (HIV) infeksiyonunun erken tan\u0131s\u0131, antiretroviral tedaviye zaman\u0131nda ba\u015flanmas\u0131n\u0131 sa\u011flar, bireysel sonu\u00e7lar\u0131 iyile\u015ftirir ve bula\u015fmay\u0131 azalt\u0131r. Laboratuvar tan\u0131s\u0131, yaln\u0131zca antikor saptayan testlerden HIV-1 p24 antijeni ile HIV-1 ve HIV-2 antikorlar\u0131n\u0131 birlikte saptayan d\u00f6rd\u00fcnc\u00fc ku\u015fak kombinasyon testlerine do\u011fru geli\u015fmi\u015ftir. p24 antijeninin saptanmas\u0131, yaln\u0131zca antikor temelli testlere k\u0131yasla infeksiyonun edinilmesi ile laboratuvar taraf\u0131ndan tan\u0131nmas\u0131 aras\u0131ndaki s\u00fcreyi k\u0131salt\u0131r (1,2).<\/p>\n<p>Y\u00fcksek analitik duyarl\u0131l\u0131k tarama testleri i\u00e7in zorunludur; ancak reaktif bir tarama sonucu kesin tan\u0131 anlam\u0131na gelmez. Bir tarama testinin pozitif prediktif de\u011feri, test edilen pop\u00fclasyondaki HIV prevalans\u0131ndan g\u00fc\u00e7l\u00fc bi\u00e7imde etkilenir. Bu nedenle, \u00f6zg\u00fcll\u00fc\u011f\u00fc y\u00fcksek testler bile \u00f6n test olas\u0131l\u0131\u011f\u0131n\u0131n d\u00fc\u015f\u00fck oldu\u011fu hastane pop\u00fclasyonlar\u0131nda do\u011frulanmayan reaktif sonu\u00e7lara yol a\u00e7abilir (3\u20136). Yanl\u0131\u015f veya \u00e7\u00f6z\u00fcmlenmemi\u015f reaktivite kayg\u0131ya, gereksiz sevklere ve \u00f6zellikle gebelik ile acil bak\u0131mda klinik kararlar\u0131n g\u00fc\u00e7le\u015fmesine neden olabilir (6,7).<\/p>\n<p>G\u00fcncel tan\u0131 algoritmalar\u0131, ilk d\u00f6rd\u00fcnc\u00fc ku\u015fak testi ek serolojik ayr\u0131mlama ve n\u00fckleik asit testleriyle birle\u015ftirerek bu s\u0131n\u0131rl\u0131l\u0131\u011f\u0131 azaltmay\u0131 ama\u00e7lar. Baz\u0131 laboratuvarlar, erken antijen saptama yetene\u011fini korurken gereksiz y\u00f6nlendirmeleri azaltmak i\u00e7in ara basamakta farkl\u0131 bir d\u00f6rd\u00fcnc\u00fc ku\u015fak platform kullanmaktad\u0131r. \u0130ki ard\u0131\u015f\u0131k kombinasyon testini kullanan \u00e7al\u0131\u015fmalar, do\u011frulanmayan reaktivitenin ve operasyonel i\u015f y\u00fck\u00fcn\u00fcn azalabilece\u011fini g\u00f6stermi\u015f; ancak uyumsuz \u00f6rneklerin dikkatle yorumlanmas\u0131 gerekti\u011fi de bildirilmi\u015ftir (8,9).<\/p>\n<p>Bir tan\u0131sal do\u011fruluk ara\u015ft\u0131rmas\u0131 olarak tasarlanmad\u0131\u011f\u0131 i\u00e7in duyarl\u0131l\u0131k, \u00f6zg\u00fcll\u00fck ve prediktif de\u011ferlerin hesaplanmad\u0131\u011f\u0131 bu \u00e7al\u0131\u015fmada \u00fc\u00e7\u00fcnc\u00fc basamak bir merkezde uygulanan HIV tarama ve do\u011frulama s\u00fcrecinin a\u015famalar\u0131ndaki \u00f6rnek da\u011f\u0131l\u0131m\u0131n\u0131n tan\u0131mlanmas\u0131 ve do\u011frulanm\u0131\u015f infeksiyonlar\u0131n yeni veya \u00f6nceden bilinen tan\u0131 olarak s\u0131n\u0131fland\u0131r\u0131lmas\u0131 ama\u00e7land\u0131.<span class=\"Apple-converted-space\">\u00a0<\/span><\/p>\n<h2><b>Y\u00d6NTEMLER<\/b><\/h2>\n<h3><b>\u00c7al\u0131\u015fma Tasar\u0131m\u0131 ve Ortam\u0131<\/b><\/h3>\n<p>Bu retrospektif tan\u0131mlay\u0131c\u0131 \u00e7al\u0131\u015fma, \u0130stanbul\u2019daki \u00fc\u00e7\u00fcnc\u00fc basamak bir e\u011fitim ve ara\u015ft\u0131rma hastanesinin t\u0131bbi mikrobiyoloji laboratuvar\u0131nda ger\u00e7ekle\u015ftirildi. May\u0131s 2024\u2013Ocak 2026 d\u00f6nemine ait laboratuvar bilgi sistemi kay\u0131tlar\u0131 incelendi; veri analizi \u015eubat\u2013Nisan 2026 d\u00f6nemi i\u00e7in yap\u0131ld\u0131. Merkezde acil laboratuvar ile merkezi laboratuvar\u0131n test i\u015f ak\u0131\u015flar\u0131 ayr\u0131yd\u0131.<\/p>\n<h3><b>\u00c7al\u0131\u015fma Pop\u00fclasyonu ve Veri Y\u00f6netimi<\/b><\/h3>\n<p>\u00c7al\u0131\u015fma d\u00f6neminde HIV antijen\/antikor tarama kayd\u0131 bulunan 18 ya\u015f ve \u00fczerindeki hastalara ait \u00f6rnekler de\u011ferlendirildi. Ayn\u0131 hastaya ait birden fazla ba\u015fvuru bulunmas\u0131 durumunda \u00e7al\u0131\u015fma d\u00f6nemindeki ilk uygun tarama \u00f6rne\u011fi analize al\u0131nd\u0131; sonraki ba\u015fvurular d\u0131\u015fland\u0131. \u0130lk reaktif \u00f6rne\u011fin ayn\u0131 analiz\u00f6rde teknik tekrar\u0131 test s\u00fcrecinin bir par\u00e7as\u0131 kabul edildi ve ayr\u0131 \u00f6rnek olarak say\u0131lmad\u0131. B\u00f6ylece analiz edilen 286 425 kay\u0131t yinelenmeyen hasta \u00f6rneklerini temsil etti. \u00c7al\u0131\u015fmada yaln\u0131zca toplu laboratuvar sonu\u00e7lar\u0131 kullan\u0131ld\u0131; ya\u015f, cinsiyet ve test tarihi de\u011fi\u015fkenleri analiz edilmedi.<\/p>\n<h3><b>Serolojik Tarama \u0130\u015f Ak\u0131\u015f\u0131<\/b><\/h3>\n<p>Acil laboratuvar\u0131na gelen serum \u00f6rnekleri ADVIA Centaur HIV Ag\/Ab Combo (Siemens Healthineers, Erlangen, Almanya) testiyle, di\u011fer laboratuvar birimlerinde i\u015flenen \u00f6rnekler ise Atellica IM Analyzer (Siemens Healthineers, Erlangen, Almanya) ile tarand\u0131. Her iki y\u00f6ntem HIV-1 p24 antijeni ile HIV-1 ve HIV-2 antikorlar\u0131n\u0131 saptayan d\u00f6rd\u00fcnc\u00fc ku\u015fak kemil\u00fcminesans imm\u00fcnoassaydir. Testler \u00fcretici talimatlar\u0131na ve rutin i\u00e7 kalite prosed\u00fcrlerine uygun olarak ger\u00e7ekle\u015ftirildi. \u00dcreticinin belirledi\u011fi e\u015fik de\u011ferinin \u00fczerinde sonu\u00e7 veren \u00f6rnek \u201creaktif\u201d kabul edildi ve ayn\u0131 sistemde yeniden \u00e7al\u0131\u015f\u0131ld\u0131. Teknik tekrarda da reaktif olan \u00f6rnek \u201ctekrarlayan reaktif\u201d olarak tan\u0131mland\u0131. Bu \u00f6rnekler kurumun rutin laboratuvar i\u015f ak\u0131\u015f\u0131 kapsam\u0131nda, farkl\u0131 analitik tasar\u0131ma sahip d\u00f6rd\u00fcnc\u00fc ku\u015fak VIDAS HIV Duo Quick (bioM\u00e9rieux, Marcy-l\u2019\u00c9toile, Fransa) ile de\u011ferlendirildi. VIDAS \u00fcretici \u00f6l\u00e7\u00fct\u00fcne g\u00f6re e\u015fik alt\u0131nda kalan sonu\u00e7 \u201cVIDAS-nonreaktif\u201d olarak kabul edildi. Bu \u00e7al\u0131\u015fma, ulusal veya uluslararas\u0131 bir tan\u0131 algoritmas\u0131n\u0131n do\u011fruluk validasyonu de\u011fil, kurumsal test ak\u0131\u015f\u0131n\u0131n tan\u0131mlay\u0131c\u0131 de\u011ferlendirmesi olarak ger\u00e7ekle\u015ftirildi.<\/p>\n<h3><b>Ek Serolojik ve Molek\u00fcler Testler<\/b><\/h3>\n<p>VIDAS-reaktif \u00f6rnekler, ulusal tan\u0131 i\u015f ak\u0131\u015f\u0131na uygun olarak Geenius HIV 1\/2 Supplemental Assay (Bio-Rad Laboratories, Marnes-la-Coquette, Fransa) ve\/veya line imm\u00fcnoassay ile ek de\u011ferlendirme yap\u0131lmas\u0131 amac\u0131yla Halk Sa\u011fl\u0131\u011f\u0131 Genel M\u00fcd\u00fcrl\u00fc\u011f\u00fc Referans Laboratuvar\u0131\u2019na g\u00f6nderildi. HIV-1 RNA testleri, \u00e7al\u0131\u015fma d\u00f6neminin ba\u015flang\u0131c\u0131ndan Haziran 2025 sonuna kadar NeuMoDx molek\u00fcler platformunda Qiagen HIV-1 testiyle (Qiagen, Hilden, Almanya), Temmuz 2025\u2019ten \u00e7al\u0131\u015fma d\u00f6neminin sonuna kadar ise ELITe BeGenius molek\u00fcler platformunda (ELITechGroup SpA, Torino, \u0130talya) ger\u00e7ekle\u015ftirildi. B\u00f6ylece \u00e7al\u0131\u015fma d\u00f6neminde HIV-1 RNA i\u00e7in kullan\u0131lan molek\u00fcler platform de\u011fi\u015ftirildi; sonu\u00e7lar bu \u00e7al\u0131\u015fmada platformlar aras\u0131nda performans kar\u015f\u0131la\u015ft\u0131rmas\u0131 yap\u0131lmadan, tan\u0131 ve izlem ama\u00e7l\u0131 toplam test say\u0131s\u0131 olarak de\u011ferlendirildi. Daha \u00f6nce kay\u0131tl\u0131 HIV tan\u0131s\u0131 olmayan ve hem HIV-1 RNA hem de ek serolojik testlerle infeksiyonu desteklenen hasta \u201cyeni tan\u0131\u201d olarak s\u0131n\u0131fland\u0131r\u0131ld\u0131. Akut HIV infeksiyonu, ek serolojik testin negatif veya belirsiz oldu\u011fu d\u00f6nemde saptanabilir HIV-1 RNA bulunmas\u0131 olarak tan\u0131mland\u0131; toplu veri setinde akut infeksiyonlar i\u00e7in ayr\u0131 bir sonu\u00e7 kategorisi bulunmad\u0131\u011f\u0131ndan akut olgu say\u0131s\u0131 raporlanmad\u0131.<\/p>\n<p>\u00c7al\u0131\u015fma Sa\u011fl\u0131k Bilimleri \u00dcniversitesi \u0130stanbul Haseki E\u011fitim ve Ara\u015ft\u0131rma Hastanesi Klinik Ara\u015ft\u0131rmalar Etik Kurulu taraf\u0131ndan 11 \u015eubat 2026 tarih ve 36-202(i) karar numaras\u0131yla onayland\u0131.<\/p>\n<h3><b>\u0130statistiksel Analiz<\/b><\/h3>\n<p>Birincil sonlan\u0131mlar; ilk platformda tekrarlayan reaktivite, VIDAS\u2019ta devam eden reaktivite, y\u00f6nlendirilen \u00f6rnekler aras\u0131nda kaydedilmi\u015f do\u011frulanm\u0131\u015f HIV infeksiyonu ve do\u011frulananlar aras\u0131nda yeni tan\u0131 oranlar\u0131yd\u0131. Kategorik veriler say\u0131 (n) ve y\u00fczde (%) olarak \u00f6zetlendi. Temel oranlar i\u00e7in kesin binom %95 g\u00fcven aral\u0131\u011f\u0131 (GA) Python 3.12.13 (Python Software Foundation, Wilmington, DE, ABD) ve SciPy 1.17.0 (SciPy Developers) kullan\u0131larak hesapland\u0131. VIDAS-nonreaktif 3102 \u00f6rne\u011fe HIV-1 RNA veya referans serolojik do\u011frulama uygulanmad\u0131. Ayr\u0131ca, VIDAS-reaktif 1378 \u00f6rnekten do\u011frulanm\u0131\u015f 188 \u00f6rnek d\u0131\u015f\u0131ndaki 1190 \u00f6rne\u011fin nihai sonu\u00e7lar\u0131 veri setinde bulunmad\u0131. Bu do\u011frulama eksiklikleri nedeniyle duyarl\u0131l\u0131k, \u00f6zg\u00fcll\u00fck, pozitif prediktif de\u011fer ve negatif prediktif de\u011fer hesaplanmad\u0131; analizler tan\u0131mlay\u0131c\u0131 nitelikte tutuldu.<\/p>\n<h2><b>BULGULAR<\/b><\/h2>\n<h3><b>Tarama ve Do\u011frulama \u0130\u015f Ak\u0131\u015f\u0131n\u0131n Sonu\u00e7lar\u0131<\/b><\/h3>\n<div id=\"attachment_32557\" style=\"width: 2201px\" class=\"wp-caption alignright\"><a href=\"https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM39.3_5735_Tablo1.png\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-32557\" class=\"size-full wp-image-32557\" src=\"https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM39.3_5735_Tablo1.png\" alt=\"\" width=\"2191\" height=\"637\" srcset=\"https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM39.3_5735_Tablo1.png 2191w, https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM39.3_5735_Tablo1-390x113.png 390w, https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM39.3_5735_Tablo1-810x235.png 810w, https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM39.3_5735_Tablo1-768x223.png 768w\" sizes=\"auto, (max-width: 2191px) 100vw, 2191px\" \/><\/a><p id=\"caption-attachment-32557\" class=\"wp-caption-text\"><strong>Tablo 1.<\/strong> HIV Tarama ve Do\u011frulama S\u00fcrecinin Ard\u0131\u015f\u0131k A\u015famalar\u0131ndaki Sonu\u00e7lar<\/p><\/div>\n<div id=\"attachment_32555\" style=\"width: 2195px\" class=\"wp-caption alignright\"><a href=\"https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM-5735-Sekil1.png\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-32555\" class=\"size-full wp-image-32555\" src=\"https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM-5735-Sekil1.png\" alt=\"\" width=\"2185\" height=\"1438\" srcset=\"https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM-5735-Sekil1.png 2185w, https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM-5735-Sekil1-390x257.png 390w, https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM-5735-Sekil1-810x533.png 810w, https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM-5735-Sekil1-768x505.png 768w\" sizes=\"auto, (max-width: 2185px) 100vw, 2185px\" \/><\/a><p id=\"caption-attachment-32555\" class=\"wp-caption-text\"><strong>\u015eekil 1.<\/strong> \u00c7al\u0131\u015fmaya Al\u0131nan Hasta \u00d6rneklerinin HIV Tarama ve Do\u011frulama S\u00fcrecindeki Da\u011f\u0131l\u0131m\u0131n\u0131 G\u00f6steren Ak\u0131\u015f \u015eemas\u0131<\/p><\/div>\n<p>Yirmi bir ayl\u0131k \u00e7al\u0131\u015fma d\u00f6neminde 18 ya\u015f ve \u00fczerindeki hastalara ait, yinelenmeyen toplam 286 425 serum \u00f6rne\u011fine d\u00f6rd\u00fcnc\u00fc ku\u015fak HIV antijen\/antikor taramas\u0131 uyguland\u0131. \u0130lk test platformunda tekrarlayan reaktivite 4480 \u00f6rnekte saptand\u0131 (%1.56; %95 GA: %1.52\u2013%1.61). Bu \u00f6rnekler VIDAS HIV Duo Quick ile de\u011ferlendirildi\u011finde reaktivite 1378 \u00f6rnekte devam etti (%30.76; %95 GA: %29.41\u2013%32.13), 3102 \u00f6rnekte ise tekrarlanmad\u0131 (%69.24). VIDAS-nonreaktif 3102 \u00f6rne\u011fe HIV-1 RNA veya referans serolojik do\u011frulama uygulanmad\u0131; bu nedenle bu \u00f6rnekler HIV-negatif ya da yanl\u0131\u015f reaktif olarak kesin bi\u00e7imde s\u0131n\u0131fland\u0131r\u0131lmad\u0131 (Tablo 1 ve \u015eekil 1).<\/p>\n<h3><b>Do\u011frulanm\u0131\u015f ve Yeni Tan\u0131 Alan \u0130nfeksiyonlar<\/b><\/h3>\n<div id=\"attachment_32559\" style=\"width: 1084px\" class=\"wp-caption alignright\"><a href=\"https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM39.3_5735_Tablo2.png\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-32559\" class=\"size-full wp-image-32559\" src=\"https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM39.3_5735_Tablo2.png\" alt=\"\" width=\"1074\" height=\"408\" srcset=\"https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM39.3_5735_Tablo2.png 1074w, https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM39.3_5735_Tablo2-390x148.png 390w, https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM39.3_5735_Tablo2-810x308.png 810w, https:\/\/www.klimikdergisi.org\/wp-content\/uploads\/2026\/09\/KLM39.3_5735_Tablo2-768x292.png 768w\" sizes=\"auto, (max-width: 1074px) 100vw, 1074px\" \/><\/a><p id=\"caption-attachment-32559\" class=\"wp-caption-text\"><strong>Tablo 2.<\/strong> HIV \u0130nfeksiyonu Do\u011frulanan Hasta \u00d6rneklerinin<br \/>S\u0131n\u0131fland\u0131r\u0131lmas\u0131<\/p><\/div>\n<p>Referans laboratuvara g\u00f6nderilen 1378 VIDAS-reaktif \u00f6rne\u011fin 188\u2019inde HIV infeksiyonunun do\u011fruland\u0131\u011f\u0131 kaydedildi (%13.64; %95 GA: %11.87\u2013%15.57). Bunlar\u0131n 100\u2019\u00fc \u00e7al\u0131\u015fma d\u00f6neminde yeni tan\u0131 alan hastalara (%53.19; %95 GA: %45.79\u2013%60.49), 88\u2019i ise \u00f6nceden HIV tan\u0131s\u0131 bulunan hastalara (%46.81) aitti. Yeni tan\u0131 alan 100 hastan\u0131n tamam\u0131nda infeksiyon hem HIV-1 RNA hem de ek serolojik testlerle desteklendi. Kalan 1190 \u00f6rne\u011fin referans laboratuvar nihai sonu\u00e7lar\u0131 \u00e7al\u0131\u015fma veri setinde bulunmad\u0131\u011f\u0131ndan negatif, belirsiz veya sonu\u00e7lanmam\u0131\u015f olarak ayr\u0131\u015ft\u0131r\u0131lmas\u0131 ve HIV-1 RNA ya da ba\u015fka ek test uygulan\u0131p uygulanmad\u0131\u011f\u0131n\u0131n belirlenmesi m\u00fcmk\u00fcn olmad\u0131. Bu grup \u015eekil 1\u2019de \u201cnihai sonucu veri setinde bulunmayan\u201d olarak g\u00f6sterildi.<\/p>\n<h3><b>Molek\u00fcler Test Hacmi<\/b><\/h3>\n<p>\u00c7al\u0131\u015fma d\u00f6neminde laboratuvarda toplam 5050 HIV-1 RNA testi ger\u00e7ekle\u015ftirildi. Bu testlerin t\u00fcm\u00fc 100 yeni tan\u0131 olgusuna ait de\u011fildi; say\u0131, yeni tan\u0131 de\u011ferlendirmelerinin yan\u0131 s\u0131ra \u00f6nceden tan\u0131l\u0131 hastalar\u0131n tedavi yan\u0131t\u0131 ve viral y\u00fck izlemi i\u00e7in yap\u0131lan tekrarl\u0131 testleri de i\u00e7eren toplam laboratuvar i\u015f y\u00fck\u00fcn\u00fc temsil etti. Toplu veri yap\u0131s\u0131 nedeniyle testler hasta baz\u0131nda ayr\u0131\u015ft\u0131r\u0131lamad\u0131 ve 5050 de\u011feri kullan\u0131larak hasta d\u00fczeyinde RNA pozitiflik oran\u0131 hesaplanmad\u0131.<\/p>\n<h2><b>\u0130RDELEME<\/b><\/h2>\n<p>Bu y\u00fcksek say\u0131da hasta \u00f6rne\u011finin de\u011ferlendirildi\u011fi \u00fc\u00e7\u00fcnc\u00fc basamak merkez verisinde, incelenen 286 425 hasta \u00f6rne\u011finin %1.56\u2019s\u0131nda ilk d\u00f6rd\u00fcnc\u00fc ku\u015fak platformlarda tekrarlayan reaktivite saptand\u0131. Bu \u00f6rneklerin %30.76\u2019s\u0131 VIDAS ile de reaktifti ve veri setinde 188 do\u011frulanm\u0131\u015f HIV infeksiyonu yer ald\u0131. Bunlar\u0131n 100\u2019\u00fc yeni tan\u0131yd\u0131. Ancak 3102 VIDAS-nonreaktif \u00f6rnek ile nihai sonucu veri setinde bulunmayan 1190 VIDAS-reaktif \u00f6rnekte do\u011frulama sonu\u00e7lar\u0131n\u0131n bulunmamas\u0131, \u00e7al\u0131\u015fma bulgular\u0131n\u0131n tan\u0131mlay\u0131c\u0131 d\u00fczeyde yorumlanmas\u0131n\u0131 gerektirmektedir.<\/p>\n<p>\u0130lk test reaktivitesinin VIDAS ile tekrarlanmad\u0131\u011f\u0131 \u00f6rnek oran\u0131 y\u00fcksekti. Bu uyumsuzluk tek bir nedenle a\u00e7\u0131klanamaz. \u0130ncelenen pop\u00fclasyonda \u00f6n test olas\u0131l\u0131\u011f\u0131n\u0131n d\u00fc\u015f\u00fck olmas\u0131, d\u00fc\u015f\u00fck d\u00fczey \u00f6zg\u00fcl olmayan sinyallerin mutlak say\u0131s\u0131n\u0131 art\u0131rm\u0131\u015f olabilir. \u0130lk platformlar ile VIDAS\u2019\u0131n antijen\/antikor yakalama tasar\u0131mlar\u0131, kullan\u0131lan reaktifler, analitik e\u015fikleri ve interferanslara duyarl\u0131l\u0131klar\u0131 farkl\u0131 olabilir. Heterofil antikorlar, otoantikorlar, gebelik, malignite, e\u015flik eden infeksiyonlar, \u00f6rnek \u00f6zellikleri ve preanalitik ya da analitik etkenler de platformlar aras\u0131 uyumsuz reaktiviteye katk\u0131da bulunabilir (3\u20137,10,11). Sinyal\/e\u015fik de\u011ferleri ve klinik de\u011fi\u015fkenler bulunmad\u0131\u011f\u0131ndan bu olas\u0131 a\u00e7\u0131klamalar\u0131n g\u00f6reli katk\u0131s\u0131 bu \u00e7al\u0131\u015fmada s\u0131nanamad\u0131.<\/p>\n<p>Farkl\u0131 analitik tasar\u0131ma sahip iki testin ard\u0131\u015f\u0131k kullan\u0131m\u0131, referans laboratuvara g\u00f6nderilecek \u00f6rnek say\u0131s\u0131n\u0131 azaltabilir. Avidor ve arkada\u015flar\u0131n\u0131n (8) yapt\u0131\u011f\u0131 \u00e7al\u0131\u015fmada, iki d\u00f6rd\u00fcnc\u00fc ku\u015fak testin ard\u0131ndan INNO-LIA veya Geenius do\u011frulamas\u0131n\u0131 i\u00e7eren bir yakla\u015f\u0131m de\u011ferlendirilmi\u015f ve y\u00fcksek \u00f6zg\u00fcll\u00fck bildirilmi\u015ftir. Yak\u0131n tarihli 380 390 \u00f6rneklik bir kohortta da reaktif \u00f6rneklerin ek d\u00f6rd\u00fcnc\u00fc ku\u015fak testlerle yeniden de\u011ferlendirilmesinin yanl\u0131\u015f pozitif y\u00f6nlendirmeleri azaltabilece\u011fi raporlanm\u0131\u015ft\u0131r (9). \u00c7al\u0131\u015fmam\u0131zda VIDAS kullan\u0131m\u0131 sonras\u0131nda 3102 \u00f6rnek referans do\u011frulamaya g\u00f6nderilmedi. Bununla birlikte, bu durumun gereksiz sevkleri g\u00fcvenle \u00f6nledi\u011fi sonucuna var\u0131lamaz; \u00e7\u00fcnk\u00fc bu \u00f6rneklere molek\u00fcler veya referans do\u011frulama uygulanmam\u0131\u015ft\u0131.<\/p>\n<p>Reaktif bir tarama sonucu kesin tan\u0131 olarak yorumlanmamal\u0131d\u0131r. Heterofil antikorlar, otoimm\u00fcn hastal\u0131klar, maligniteler, gebelik, di\u011fer infeksiyonlar ve teknik interferanslar \u00f6zg\u00fcl olmayan reaktiviteyle ili\u015fkili olabilir (5,10,11). Sonu\u00e7lar\u0131n erken ve kesin olarak yorumlanmas\u0131 kayg\u0131ya ve \u00f6zellikle acil durumlarda klinik kararlar\u0131n g\u00fc\u00e7le\u015fmesine neden olabilir. Tarama ve ek test sonu\u00e7lar\u0131n\u0131n a\u015famal\u0131 ve a\u00e7\u0131k bi\u00e7imde raporlanmas\u0131 yanl\u0131\u015f anla\u015f\u0131lma riskini azaltabilir (6).<\/p>\n<p>Y\u00fcz yeni HIV tan\u0131s\u0131n\u0131n do\u011frulanmas\u0131 klinik a\u00e7\u0131dan \u00f6nemlidir. D\u00f6rd\u00fcnc\u00fc ku\u015fak testler antikor yan\u0131t\u0131 geli\u015fmeden \u00f6nce p24 antijenini saptayabilirken, HIV-1 RNA erken infeksiyonda veya uyumsuz serolojik profillerin de\u011ferlendirilmesinde tan\u0131sal belirsizli\u011fin azalt\u0131lmas\u0131na katk\u0131 sa\u011flayabilir. Yeni tan\u0131lar\u0131n hem molek\u00fcler hem de ek serolojik testlerle desteklenmesi tan\u0131sal g\u00fcveni g\u00fc\u00e7lendirebilir. Buna kar\u015f\u0131l\u0131k, tedavi alt\u0131ndaki \u00f6nceden tan\u0131l\u0131 hastalarda viral bask\u0131lanma nedeniyle RNA saptanamayabilir; seroreaktivite ise devam edebilir. Bu nedenle \u00f6nceden tan\u0131l\u0131 88 hastan\u0131n yeni tan\u0131lardan ayr\u0131 de\u011ferlendirilmesi, izlem amac\u0131yla yap\u0131lan test sonu\u00e7lar\u0131n\u0131n tan\u0131sal ba\u015far\u0131s\u0131zl\u0131k olarak yanl\u0131\u015f s\u0131n\u0131fland\u0131r\u0131lmas\u0131n\u0131 \u00f6nleyebilir.<\/p>\n<p>\u00c7al\u0131\u015fman\u0131n g\u00fc\u00e7l\u00fc y\u00f6nleri; kesintisiz 21 ayl\u0131k rutin i\u015f ak\u0131\u015f\u0131n\u0131 yans\u0131tmas\u0131, b\u00fcy\u00fck bir \u00f6rnekleme sahip olmas\u0131 ve do\u011frulanm\u0131\u015f infeksiyonlar\u0131 yeni ve \u00f6nceden bilinen tan\u0131lar olarak ayr\u0131 sunmas\u0131d\u0131r. \u00d6rnek say\u0131s\u0131n\u0131n fazlal\u0131\u011f\u0131, test s\u00fcrecinin her a\u015famas\u0131ndaki \u00f6rnek da\u011f\u0131l\u0131m\u0131n\u0131n dar g\u00fcven aral\u0131klar\u0131yla tan\u0131mlanmas\u0131na da olanak sa\u011flad\u0131.<\/p>\n<p>\u00c7al\u0131\u015fman\u0131n baz\u0131 s\u0131n\u0131rl\u0131l\u0131klar\u0131 bulunmaktad\u0131r. Retrospektif ve toplu veri yap\u0131s\u0131 nedeniyle klinik tan\u0131lar, risk fakt\u00f6rleri, tedavi durumu ve demografik de\u011fi\u015fkenler de\u011ferlendirilemedi; test a\u015famalar\u0131 t\u00fcm \u00f6rneklerde hasta baz\u0131nda e\u015fle\u015ftirilemedi. Test hacimleri Atellica IM ve ADVIA Centaur platformlar\u0131na g\u00f6re ayr\u0131lmad\u0131\u011f\u0131ndan platforma \u00f6zg\u00fc kar\u015f\u0131la\u015ft\u0131rma yap\u0131lamad\u0131. Sinyal\/e\u015fik de\u011ferleri bulunmad\u0131\u011f\u0131ndan e\u015fik analizi yap\u0131lamad\u0131. VIDAS-nonreaktif 3102 \u00f6rne\u011fe HIV-1 RNA veya referans do\u011frulama uygulanmad\u0131. VIDAS-reaktif 1378 \u00f6rne\u011fin 1190\u2019\u0131nda nihai do\u011frulama sonucu ve ek test bilgisi veri setinde mevcut de\u011fildi. Bu nedenle \u00f6rnekler kesin yanl\u0131\u015f reaktif veya HIV-negatif olarak s\u0131n\u0131fland\u0131r\u0131lamad\u0131; duyarl\u0131l\u0131k, \u00f6zg\u00fcll\u00fck, pozitif prediktif de\u011fer ve negatif prediktif de\u011fer hesaplanamad\u0131. Son olarak, 5050 HIV-1 RNA testi tan\u0131 ve tekrarl\u0131 izlem testlerinin toplam\u0131n\u0131 temsil etti\u011finden hasta d\u00fczeyinde molek\u00fcler pozitiflik oran\u0131 belirlenemedi.<\/p>\n<p>Sonu\u00e7 olarak, ikinci bir d\u00f6rd\u00fcnc\u00fc ku\u015fak testin kullan\u0131ld\u0131\u011f\u0131 kurumsal HIV test s\u00fcreci, \u00fc\u00e7\u00fcnc\u00fc basamak bir merkezde \u00f6rneklerin a\u015famalar aras\u0131ndaki da\u011f\u0131l\u0131m\u0131n\u0131 ve 100 yeni HIV tan\u0131s\u0131n\u0131 ortaya koymu\u015ftur. Bu yakla\u015f\u0131m referans laboratuvara g\u00f6nderilen \u00f6rnek say\u0131s\u0131n\u0131 azaltabilir; ancak do\u011frulama yap\u0131lmayan gruplar nedeniyle klinik g\u00fcvenlik ve tan\u0131sal do\u011fruluk a\u00e7\u0131s\u0131ndan sa\u011flad\u0131\u011f\u0131 yarar bu verilerle g\u00f6sterilemez. Hasta d\u00fczeyinde e\u015fle\u015ftirilmi\u015f serolojik ve molek\u00fcler sonu\u00e7lar\u0131 i\u00e7eren ileri \u00e7al\u0131\u015fmalar, yerel test s\u00fcre\u00e7lerinin g\u00fcvenli bi\u00e7imde iyile\u015ftirilmesine katk\u0131 sa\u011flayabilir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>G\u0130R\u0130\u015e \u0130nsan imm\u00fcn yetmezlik virusu (HIV) infeksiyonunun erken tan\u0131s\u0131, antiretroviral tedaviye zaman\u0131nda ba\u015flanmas\u0131n\u0131 sa\u011flar, bireysel sonu\u00e7lar\u0131 iyile\u015ftirir ve bula\u015fmay\u0131 azalt\u0131r. Laboratuvar tan\u0131s\u0131, yaln\u0131zca antikor saptayan testlerden HIV-1 p24 antijeni ile HIV-1 ve HIV-2 antikorlar\u0131n\u0131 birlikte saptayan d\u00f6rd\u00fcnc\u00fc ku\u015fak kombinasyon testlerine do\u011fru geli\u015fmi\u015ftir. p24 antijeninin saptanmas\u0131, yaln\u0131zca antikor temelli testlere k\u0131yasla infeksiyonun edinilmesi ile laboratuvar taraf\u0131ndan [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":32664,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[5129],"tags":[3196,6385,6386,6387,3512],"class_list":["post-32463","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ozgun-arastirma","tag-hiv-infeksiyonu","tag-hiv-testi","tag-kitle-taramasi","tag-nukleik-asit-amplifikasyon-teknikleri","tag-serolojik-testler"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/posts\/32463","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/comments?post=32463"}],"version-history":[{"count":4,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/posts\/32463\/revisions"}],"predecessor-version":[{"id":32641,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/posts\/32463\/revisions\/32641"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/media\/32664"}],"wp:attachment":[{"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/media?parent=32463"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/categories?post=32463"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/tags?post=32463"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}