International journal of laboratory hematology · 2026
Real-World Performance of the STic Expert HIT Kit and the Diagnostic Dilemma of Borderline Results in Heparin Induced Thrombocytopenia.
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Dahiya Surbhi, Kotwal Jyoti, Langer Sabina, Prakhar Pallavi, Pandey Sachita
Аннотация
INTRODUCTION: Rapid immunoassays are widely used for diagnosing heparin-induced thrombocytopenia (HIT). The STic Expert HIT kit is commonly employed, but its diagnostic accuracy in unselected, real-world populations requires robust evaluation against an appropriate reference standard. This study evaluates the diagnostic accuracy of the STic Expert HIT kit using the heparin-induced platelet aggregation test (PAT) as the comparator.
METHODS: This cross-sectional diagnostic accuracy study was conducted from January 2023 to April 2025. A consecutive series of 320 patients with suspected HIT underwent parallel testing with the STic Expert HIT kit (index test) and PAT (comparator). The 4T score was calculated prospectively for all patients. Borderline visual results on the STic kit were classified according to epidemiological recommendations: as false negative if PAT-positive and false positive if PAT-negative. Diagnostic accuracy measures-sensitivity, specificity, predictive values, and likelihood ratios-were calculated with 95% confidence intervals. The study is reported in accordance with the STARD 2015 checklist.
RESULTS: Among 320 consecutive patients (median age 45.6 years; range 0.19-89), the prevalence of PAT-confirmed HIT was 16.3% (52/320). Following the STARD guidelines, the STic Expert HIT kit demonstrated a sensitivity of 57.5% (95% CI: 42.2-71.6) and specificity of 92.5% (95% CI: 88.8-95.1). The positive predictive value was 58.8% (95% CI: 46.2-70.4) and negative predictive value was 92.1% (95% CI: 89.6-94.1). The positive likelihood ratio was 7.67 (95% CI: 5.10-11.52) and negative likelihood ratio was 0.46 (95% CI: 0.32-0.66). The area under the ROC curve was 0.75 (95% CI: 0.67-0.83). Borderline results constituted 6.6% (21/320) of tests; of these, 33.3% (7/21) were true positives and 66.7% (14/21) were false positives.
CONCLUSION: In this large, real-world diagnostic accuracy study, the STic Expert HIT kit demonstrated limited sensitivity for HIT diagnosis. The test is not suitable for ruling out HIT due to its suboptimal sensitivity. Borderline results are common and require integration with pre-test probability. These findings highlight the need for confirmatory functional testing in suspected HIT, particularly in high-probability settings.
METHODS: This cross-sectional diagnostic accuracy study was conducted from January 2023 to April 2025. A consecutive series of 320 patients with suspected HIT underwent parallel testing with the STic Expert HIT kit (index test) and PAT (comparator). The 4T score was calculated prospectively for all patients. Borderline visual results on the STic kit were classified according to epidemiological recommendations: as false negative if PAT-positive and false positive if PAT-negative. Diagnostic accuracy measures-sensitivity, specificity, predictive values, and likelihood ratios-were calculated with 95% confidence intervals. The study is reported in accordance with the STARD 2015 checklist.
RESULTS: Among 320 consecutive patients (median age 45.6 years; range 0.19-89), the prevalence of PAT-confirmed HIT was 16.3% (52/320). Following the STARD guidelines, the STic Expert HIT kit demonstrated a sensitivity of 57.5% (95% CI: 42.2-71.6) and specificity of 92.5% (95% CI: 88.8-95.1). The positive predictive value was 58.8% (95% CI: 46.2-70.4) and negative predictive value was 92.1% (95% CI: 89.6-94.1). The positive likelihood ratio was 7.67 (95% CI: 5.10-11.52) and negative likelihood ratio was 0.46 (95% CI: 0.32-0.66). The area under the ROC curve was 0.75 (95% CI: 0.67-0.83). Borderline results constituted 6.6% (21/320) of tests; of these, 33.3% (7/21) were true positives and 66.7% (14/21) were false positives.
CONCLUSION: In this large, real-world diagnostic accuracy study, the STic Expert HIT kit demonstrated limited sensitivity for HIT diagnosis. The test is not suitable for ruling out HIT due to its suboptimal sensitivity. Borderline results are common and require integration with pre-test probability. These findings highlight the need for confirmatory functional testing in suspected HIT, particularly in high-probability settings.