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AuthorSamar, Shurbaji
AuthorAl Tamimi, Faleh
AuthorAl Ghwairi, Mahmoud M.
AuthorEl Chaar, Dayana
AuthorYounes, Salma
AuthorMajdalawieh, Amin F.
AuthorPintus, GianFranco
AuthorAl-Dewik, Nader
AuthorNasrallah, Gheyath K.
Available date2024-01-14T06:58:46Z
Publication Date2023-10-31
Publication NameHeliyon
Identifierhttp://dx.doi.org/10.1016/j.heliyon.2023.e20589
ISSN24058440
URIhttps://www.sciencedirect.com/science/article/pii/S2405844023077976
URIhttp://hdl.handle.net/10576/50705
AbstractBackgroundIn the last decade, point of care testing (POCT) such as lateral flow immunoassays (LFIA) were developed for rapid TSH measurement. Most of these TSH-LFIAs are designed for qualitative measurements (i.e., if TSH values > 5, or >15 IU/L) and as screening tests for primary hypothyroidism in children and adults. Serum or plasma, but not venepuncture whole-blood or fingerstick/capillary, are usually used to quantify TSH accurately. Studies on performance evaluation of TSH-LFIAs POCT using venepuncture or fingerstick whole-blood are limited. Additionally, limited studies evaluated the performance and validity of TSH-LFIAs POCT compared to valid and reliable reference methods. To our knowledge, this is the first study to evaluate three different blood withdrawal techniques for evaluating POCT of TSH. AimWe aim to evaluate the performance of a new fluorescence-based LFIA and its Finecare™ fluorescent reader for quantitative measurement of TSH from a fingerstick, venepuncture whole-blood, and serum. Methods102 fingerstick, venepuncture whole-blood, and serum samples (with normal and abnormal TSH values) were analyzed by Finecare™ Rapid Quantitative LFIA test and Roche cobas® e 601 as a reference test. ResultsUsing serum, when compared to cobas® e 601 reference method, Finecare™ showed high sensitivity [90.5 % (69.6–98.8)] and specificity [96.3 % (89.6–99.2)] for diagnosis of thyroid abnormalities (<0.35 or >4.5 mIU/L). The actual test values (mIU/L) of Finecare™ showed excellent agreement (Cohen's Kappa = 0.85) and strong correlation (r = 0.93, p < 0.0001) with cobas® e 601. Using venepuncture whole-blood samples, Finecare™ showed similar results to serum with high sensitivity [95.2 % (76.2–99.9)], specificity [97.5 % (91.4–99.7)], excellent agreement (Cohen's Kappa = 0.91), and very strong correlation (r = 0.95, p < 0.0001) with cobas® e 601. These results suggest that Finecare™ can be used for quantitative measurement of TSH using serum or venepuncture whole-blood. These key performance indicators were slightly decreased when fingerstick whole-blood samples were used: sensitivity [85.7 %(63.7–97)], specificity [90.0 %,(81.5–96)], good agreement (Cohen's Kappa = 0.7) and very strong correlation (r = 0.9, p < 0.0001) with cobas® e 601. A subgroup analysis of abnormal TSH samples revealed a strong and significant correlation between the reference, Finecare™ whole-blood (r = 0.692; p = 0.0015), and fingerstick test Finecare™ (r = 0.66; p = 0.0025). A very strong correlation was also observed between cobas® e 601 serum and Finecare™ serum (r = 0.88; p < 0.0001). Conclusion: In comparison to the reference assay, our study demonstrates that Finecare™ exhibits high sensitivity, specificity, agreement, and a strong correlation. These findings provide evidence that Finecare™ is a reliable, valid, and accurate point-of-care test for TSH screening and quantitative measurement, especially in non- or small laboratory settings.
SponsorThis work was funded by NPRP13S-0128-200185 grant from the Qatar National Research Fund.
Languageen
PublisherElsevier
SubjectTSH
Evaluation
LIFA rapid test
Finecare
Roche
TitleHigh-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA)
TypeArticle
Issue Number10
Volume Number9
Open Access user License http://creativecommons.org/licenses/by/4.0/
dc.accessType Open Access


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