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 for accurate quantitation of TSH. Studies on performance evaluation of TSH-LFIAs POCT using venepuncture or fingerstick whole-blood are limited. Aim: We aim to evaluate the performance of a new fluorescence-based LFIA and its FinecareTM 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 FinecareTM Rapid Quantitative LFIA test and Roche CobasPro-c503 as a reference test. Results: Using serum, when compared to CobasPro-c503 reference method, FinecareTM showed high sensitivity (90.5%) and specificity (96.3%) for diagnosis of thyroid abnormalities (<0.35 or > 4.5 mIU/L). The actual test values (mIU/L) of FinecareTM showed excellent agreement (Cohen Kappa=0.85) and strong correlation (r=0.93, p<0.0001) with CobasPro-c503. Using venepuncture whole-blood samples, FinecareTM showed similar results to serum with high sensitivity (95.2%), specificity (97.5%), excellent agreement (Cohen Kappa=0.91), and very strong correlation (r=0.95, p<0.0001) with CobasPro-c503. These results suggest that FinecareTM 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%), specificity (90.0%), good agreement (Cohen Kappa=0.7) and very strong correlation (r=0.9, p<0.0001) with CobasPro-c503. Conclusion: Our results indicate that the FinecareTM is appropriate for TSH screening and quantitative measurement of TSH using serum samples and fingersticks, particularly in none or small laboratory settings.
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