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2017 ; 12
(6
): e0178289
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Rapid immunoassays for diagnosis of heparin-induced thrombocytopenia: Comparison
of diagnostic accuracy, reproducibility, and costs in clinical practice
#MMPMID28594835
Bankova A
; Andres Y
; Horn MP
; Alberio L
; Nagler M
PLoS One
2017[]; 12
(6
): e0178289
PMID28594835
show ga
BACKGROUND: Immunoassays are crucial in the work-up of patients with suspected
heparin-induced thrombocytopenia (HIT) and rapid tests have been recently
developed. However, comparative data on diagnostic accuracy, reproducibility, and
analytical costs of different immunoassays in clinical practice are limited.
METHODS: Samples of 179 consecutive patients evaluated for suspected HIT in
clinical practice using a polyspecific enzyme-linked immunoabsorbent assay (GTI
diagnostics; ELISA) and a rapid particle gel immunoassay (PaGIA), were
additionally analysed with a IgG-specific chemiluminescent immunoassay (AcuStar
HIT-IgG). Presence of HIT was defined as a positive functional heparin-induced
platelet aggregation test. Diagnostic accuracy was determined for low,
intermediate and high thresholds as previously established (ELISA: optical
density 0.4, 1.3, and 2.0 respectively; PaGIA: positive/negative, titre of 4,
titre of 32; AcuStar HIT-IgG: 1.0 U/ml, 2.8, 9.4) and reproducibility was
assessed by repeated measurements. Costs of test determination were calculated
taking reagents, controls, and working time of technicians according to Swiss
health care system into account. RESULTS: Data on PaGIA results were available
for 171 patients (95.5%), ELISA for 144 patients (80.4%), and AcuStar HIT-IgG for
179 patients (100%). Sensitivity was above 95% for all assays at low and
intermediate thresholds. Specificity increased with higher thresholds and was
above 90% for all assays with intermediate and high thresholds. Specificity of
AcuStar HIT-IgG (92.8%; 95% CI 87.7, 96.2) was significantly higher than PaGIA
(83.0%; 95% CI 76.3, 88.5) and higher than ELISA (81.8%, 95% CI 74.2, 88.0) at
low threshold (p<0.05). Reproducibility was adequate for all assays. Total costs
per test were CHF 51.02 for ELISA, 117.70 for AcuStar HIT-IgG, and 83.13 for
PaGIA. CONCLUSIONS: We observed favourable diagnostic accuracy measures and a
high reproducibility for PaGIA and AcuStar HIT-IgG. Implementation into
24-hours-service might improve patient care but the results must be confirmed in
other settings and larger populations as well.