Procena analitičkih i kliničkih karakteristika Siemens IMMULITE®2000 TSI metode za određivanje antitela na receptore tireotropina

Metoda za određivanje antitela na receptore tireotropina

DOI: https://doi.org/10.5937/jomb0-55873
Ključne reči: antitela na receptore stimulišućeg hormona štitne žlezde, analitička i klinička osetljivost i specifičnost

Sažetak


Sažetak: Uprkos komercijalno poboljšanim, standardizovanim rutinskim metodama koje se koriste u medicinskim laboratorijima, preciznoj laboratorijskoj medicini nedostaje harmonizacija rezultata kako bi laboratorijski rezultat bio koristan za njegovu namenu. Dodatno, za dobijanje pouzdanih laboratorijskih rezultata i preciznijih dijagnoza važno je i preporučuje se da svaka laboratorija potvrdi analitičke i kliničke karakteristike primenjene metode. Cilj ove studije bio je da se procene analitičke i kliničke performanse IMMULITE®2000 TSI imunohemijskog testa za određivanje autoreaktivnih antitela na receptore hormona koji stimulišu štitnu žlezdu (TSH-R-Ab).

Metode: U studiju je uključeno ukupno 86 bolesnika sa klinički prisutnom Gravesovom orbitopatijom i 23 zdrava dobrovoljca kao kontrolna grupa. Ukupna koncentracija TSH-R-Ab određena je pomoću ECLIA (Elecsys Anti-TSHR Immunoassay Roche Diagnostics, GmbH, Mannheim, Njemačka) na analizatoru Cobas e411 (Roche, Diagnostics, GmbH). Koncentracija TSH-R-Ab merena je metodom CLIA (IMMULITE TSI 2000, Siemens Healthcare Diagnostics, UK). Netačnost metode ispitana je pomoću dva nivoa komercijalnih kontrolnih uzoraka (niska i visoka koncentracija analita).

Rezultati: Dobijeni rezultati ispunjavaju opšte minimalne zahteve za analitičke performanse laboratorijskih metoda (CV <5%). Ukupna laboratorijska netačnost bila je prihvatljiva prema smernicama FDA (CV<20%). Rezultati su pokazali statistički značajnu korelaciju između analiziranih metoda (r=0,9041, p ˂ 0,0001), ali sa relativnim odstupanjem od 24,5%. Najbolji odnos osetljivosti i specifičnosti utvrđen ROC analizom (93,3 % odnosno 100 %) dobijen je za graničnu vrednost od 0,1215 IU/L, što je značajno niže u poređenju sa graničnom vrednošću koju je odredio proizvođač (0,55 IU/L).

Zaključak: IMMULITE 2000 TSI imunohemijski test za kvantifikaciju TSH-R-Ab potvrdio je adekvatan nivo preciznosti, koji je neophodan za rutinsku upotrebu. Međutim, potrebna su dalja istraživanja kako bi se procenila njegova analitička specifičnost.

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Objavljeno
2025/02/21
Broj časopisa
Vol. 44 Br. 3 (2025): Journal of Medical Biochemistry
Rubrika
Original paper

Sva prava zadržana (c) 2025 Neda Milinković, Marija Sarić, Ana Ružanović, Miloš Žarković, Jasmina Ćirić, Iva Perović Blagojević, Ana Marija Mastilović, Svetlana Ignjatović, Biljana Nedeljković Beleslin

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