Evaluation of a point-of-care test for quantitative determination of total thyroxine in feline serum.

OBJECTIVES

Total thyroxine (TT4) evaluation is the most commonly used first-line test for the diagnosis and monitoring of cats with hyperthyroidism. Vcheck T4 is a point-of-care immunoassay that measures TT4 using a Vcheck V200 analyser. This study aimed to evaluate the analytic performance of the Vcheck T4 assay in feline sera and the agreement in the classification of normal, high and low TT4 concentrations of Vcheck T4 with those measured by an enzyme immunoassay (EIA).

METHODS

Assay precision, reproducibility and linearity were evaluated for the Vcheck T4. For method comparison, TT4 concentrations in 73 serum samples were analysed by both methods.

RESULTS

Vcheck T4 demonstrated good precision, reproducibility (intra- and inter-assay coefficients of variation between 3% and 13.5%) and linearity in the diagnostic range of <0.5 and >8 μg/dl. The correlation coefficient was 0.87, Passing-Bablok regression showed a proportional, but not constant bias, Bland-Altman plots revealed a mean difference of +0.5 μg/dl. The overall inter-rater agreement () between TT4 EIA and Vcheck results was substantial ( = 0.69), with 82.2% of concordant results. As a diagnostic test for hyperthyroidism, Vcheck T4 showed a sensitivity and specificity of 88.9% and 84.4%, and a positive predictive value (PPV) and negative predictive value (NPV) of 44.5% and 98.2%, respectively.

CONCLUSIONS AND RELEVANCE

Vcheck T4 assay provided precise and reproducible results in substantial agreement with the EIA. Given the high NPV, Vcheck T4 is useful in ruling out hyperthyroidism when screening cats, but, based on low PPV, samples with results with high TT4 need to be analysed by another reference method. Further analysis with haemolytic, icteric and lipaemic samples is needed to assess the test performance. Finally, the reference intervals provided by the manufacturer require verification, and TT4 intervals specific to this method must be established in future studies.