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Sensitivity of three thyrotropin receptor antibody assays in thyroid-associated orbitopathy
Osetljivost tri testa za određivanje antitela na receptor za tireostimulišući hormon kod pacijenata sa orbitopatijom udruženom sa štitnom žlezdom
dc.creator | Sarić-Matutinović, Marija | |
dc.creator | Diana, Tanja | |
dc.creator | Nedeljković-Beleslin, Biljana | |
dc.creator | Ćirić, Jasmina | |
dc.creator | Žarković, Miloš | |
dc.creator | Perović Blagojević, Iva | |
dc.creator | Kahaly, George | |
dc.creator | Ignjatović, Svetlana | |
dc.date.accessioned | 2022-05-11T07:41:45Z | |
dc.date.available | 2022-05-11T07:41:45Z | |
dc.date.issued | 2022 | |
dc.identifier.issn | 1452-8258 | |
dc.identifier.uri | https://farfar.pharmacy.bg.ac.rs/handle/123456789/4091 | |
dc.description.abstract | Background: Thyrotropin receptor autoantibodies (TSH-R-Ab) are indispensable biomarkers in the laboratory assessment of thyroid-associated orbitopathy (TAO). Clinical sensitivity of three different assays for TSH-R-Ab determination was evaluated in patients with TAO. Methods: 87 consecutive TAO patients were enrolled and their serum samples analyzed in parallel with three assays. An ECLIA competitive binding and a chemiluminescent bridge immunoassay were used to measure total and bind-ing TSH-R-Ab concentration, while their functional activity was determined using a stimulatory TSH-R-Ab (TSAb) cell-based bioassay. Results: Compared to the two binding assays (ECLIA p<0.001, bridge p=0.003), the TSAb bioassay was more sensitive pertaining to the positive detection of TSH-R-Ab in TAO patients. No difference (p=0.057) was noted between the ECLIA and bridge assays regarding sensitivity rate. All patients with active and/or moderate-to-severe TAO tested positive in the TSAb bioassay (100% and 100%, respectively), while the positivity rates for bridge and ECLIA binding assays were 89.7% and 82.1% for active TAO, and 90.2% and 86.3% for severe TAO, respectively. Negative predictive values of the bioassay, bridge, and ECLIA assays were 100%, 75%, and 71%, respectively for active TAO, and 100%, 86%, and 71%, respectively for moderate-to-severe TAO. The superiority of the bioassay was most prominent in euthyroid (ET) TAO. Positivity rates of the TSAb bioassay, bridge and ECLIA binding assays were 89.6%, 75%, and 64.6%, respectively for inactive TAO; 86.1%, 69.4%, and 52.8%, respectively for mild TAO; 87.5%, 62.5%, and 12.5%, respectively for euthyroid TAO. The bridge assay correlated better with the ECLIA binding assay (r=0.893, p<0.001), compared to the bioassay (r=0.669, p<0.001). Conclusions: In patients with TAO of various activity and severity, the TSAb bioassay demonstrates a superior clinical performance compared to both ECLIA and bridge binding assays. | |
dc.description.abstract | Uvod: Autoantitela na receptore za tireostimulišući hormon (TSH-R-Ab) su nezamenljivi biomarkeri u laboratorijskoj proceni orbitopatije udru'ene sa štitnom žlezdom (TAO). U radu je procenjena klinička osetljivost tri različita testa za određivanje TSH-R-Ab kod pacijenata sa TAO. Metode: U studiju je ključeno 87 uzastopnih pacijenata sa TAO i njihovi uzorci seruma su analizirani paralelno sa tri testa. Za merenje ukupne i vezujuće koncentracije TSH-RAb korišćeni su ECLIA imunohemijski test kompetitivnog vezivanja i hemiluminiscentni imunohemijski "sendvič" test, dok je njihova funkcionalna aktivnost određena pomoću ćelijskog biološkog testa (bioeseja) za određivanje stimulatornih TSH-R-Ab (TSAb). Rezultati: U poređenju sa dva imunohemijska testa vezivanja (ECLIA P<0,001, "sendvič test" P=0,003), TSAb bioesej se pokazao najosetljivijim u pogledu pozitivne detekcije TSH-RAb kod TAO pacijenata. Nikakva razlika nije detektovana (P=0,057) između ECLIA i "sendvič" testa u pogledu stope osetljivosti. TSAb bioesej je bio pozitivan kod svih pacijenata sa aktivnom i/ili umerenom do teškom TAO (redom 100% i 100%), dok su stope pozitivnosti za sendvič i ECLIA imunohemijski test bile 89,7% i 82,1% za aktivnu TAO, i 90,2% i 86,3% za tešku TAO, redom. Negativne prediktivne vrednosti bioeseja, "sendvič" i ECLIA testova bile su redom 100%, 75% i 71%, za aktivnu TAO, odnosno 100%, 86% i 71%, redom za umerenu do tešku TAO. Superiornost biološke analize bila je najistaknutija kod eutiroidnog oblika (ET) TAO. Stope pozitivnosti TSAb bioeseja, "sendvič" i ECLIA testova vezivanja bile su redom 89,6%, 75% i 64,6%, za neaktivnu TAO; 86,1%, 69,4% i 52,8% za blagu TAO; 87,5%, 62,5% i 12,5% za eutiroidni TAO. "Sendvič" imunohemijski test je bio u boljoj korelaciji sa ECLIA testom kompetitivnog vezivanja (r=0,893, P<0,001), u poređenju sa bioesejom (r=0,669, P<0,001). Zaključak: Kod pacijenata sa TAO različite aktivnosti i težine TSAb bioesej pokazuje superiorne kliničke performanse u poređenju sa obe vrste imunohemijskih testova vezivanja (ECLIA i "sendvič test"). | |
dc.publisher | Society of Medical Biochemists of Serbia | |
dc.relation | info:eu-repo/grantAgreement/MESTD/Basic Research (BR or ON)/175036/RS// | |
dc.relation | info:eu-repo/grantAgreement/MESTD/inst-2020/200161/RS// | |
dc.rights | openAccess | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0/ | |
dc.source | Journal of Medical Biochemistry | |
dc.subject | bioassay | |
dc.subject | bridge binding assay | |
dc.subject | ECLIA binding assay | |
dc.subject | thyroid-associated orbitopathy | |
dc.subject | thyrotropin receptor antibodies | |
dc.subject | orbitopatija udružena sa žtitnom žlezdom | |
dc.subject | antitela na receptor za tireostimulišući hormon | |
dc.subject | bioesej | |
dc.subject | "sendvič" imunohemijski test vezivanja | |
dc.subject | ECLIA test vezivanja | |
dc.title | Sensitivity of three thyrotropin receptor antibody assays in thyroid-associated orbitopathy | |
dc.title | Osetljivost tri testa za određivanje antitela na receptor za tireostimulišući hormon kod pacijenata sa orbitopatijom udruženom sa štitnom žlezdom | |
dc.type | article | |
dc.rights.license | BY | |
dc.citation.volume | 41 | |
dc.citation.issue | 2 | |
dc.citation.spage | 211 | |
dc.citation.epage | 220 | |
dc.citation.rank | M23 | |
dc.identifier.wos | 000772917800006 | |
dc.identifier.doi | 10.5937/jomb0-34718 | |
dc.identifier.scopus | 2-s2.0-85128942234 | |
dc.identifier.fulltext | http://farfar.pharmacy.bg.ac.rs/bitstream/id/9642/bitstream_9642.pdf | |
dc.type.version | publishedVersion |