| Autor: |
Samar Shurbaji, Faleh Al Tamimi, Mahmoud M. Al Ghwairi, Dayana El Chaar, Salma Younes, Amin F. Majdalawieh, GianFranco Pintus, Nader Al-Dewik, Gheyath K. Nasrallah |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
|
| Zdroj: |
Heliyon, Vol 9, Iss 10, Pp e20589- (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2405-8440 |
| DOI: |
10.1016/j.heliyon.2023.e20589 |
| Popis: |
Background: In 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. Aim: We 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. Methods: 102 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. Results: Using 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 (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 |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
|
