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1.
Am J Clin Pathol ; 161(4): 349-359, 2024 Apr 03.
Artigo em Inglês | MEDLINE | ID: mdl-38071967

RESUMO

OBJECTIVES: Analysis of laboratory value often lacks assessment of the laboratory's impact on quality of care. In this study, we aimed to determine the impact of bringing a heparin-induced thrombocytopenia (HIT) antibody assay in-house on a quality metric-patient hospital length of stay (LOS)-and assess any associated cost savings. METHODS: A retrospective review of patient visits with a HIT antibody assay over a 7-year period determined the mean LOS in send-out vs in-house HIT antibody assay cohorts as well as cohorts of positive and negative results. Our systemwide mean LOS and metrics of acuity were analyzed. We performed a financial analysis of estimated cost savings. RESULTS: We found a mean LOS reduction of 3.97 days in the in-house cohort, with no evidence of a systemwide LOS decrease or a decline in patient acuity. This reduction was largely driven by a reduction in LOS among patients with a negative assay result. We found an estimated total cost savings of $3.9 million and an estimated mean savings per patient of $7,305, despite escalating health care costs over time. CONCLUSIONS: We demonstrated a reduction in LOS following the introduction of an in-house HIT antibody assay that cannot be attributed to either systemwide initiatives or reduced patient acuity and was driven largely by patients with negative assays. This reduction was associated with significant estimated cost savings.


Assuntos
Trombocitopenia , Humanos , Redução de Custos , Tempo de Internação , Trombocitopenia/induzido quimicamente , Trombocitopenia/diagnóstico , Estudos Retrospectivos , Anticorpos , Hospitais
2.
J Pak Med Assoc ; 73(12): 2375-2378, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38083915

RESUMO

Objectives: To evaluate the relevance of thrombocytopenia to other disease states in patients reporting at a haematology laboratory. METHODS: The cross-sectional, retrospective study was conducted at the Dow Diagnostic Research and Reference Laboratory of the Dr Ishrat ul Ebad Khan Institute of Blood Diseases, Dow University of Health Sciences, Karachi, and comprised data from the blood bank and haematology laboratory related to patients who visited during October 2021to August 2022. Data was analysed using SPSS 26. RESULTS: Of the 1,249 patients with mean age 38.5±19.7 years (range: 0-89 years), 79(6.3%) were aged <12 years, 592(47.4%) were aged 12-40 years and 578(46.3%) were aged >40. Most of the patients were males 793 (63.5%), and 604(48.4%) had Grade 1 thrombocytopenia. Among the females, Grade 1 thrombocytopenia was found in 246(53.9%) and Grade 2 in 140(30.7%) patients compared to 358(45.1%) and 222(28%) in males, respectively (p<0.05). Association between thrombocytopenia and diagnoses was not significant (p>0.05). CONCLUSIONS: Thrombocytopenia was found to be strongly associated with gender.


Assuntos
Anemia , Trombocitopenia , Masculino , Feminino , Humanos , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Estudos Retrospectivos , Estudos Transversais , Trombocitopenia/diagnóstico , Trombocitopenia/epidemiologia
3.
J Thromb Haemost ; 20(12): 2896-2908, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36107495

RESUMO

BACKGROUND: Vaccine-induced thrombotic thrombocytopenia (VITT) is a rare complication of adenovirus-based vaccines aimed to prevent and minimize COVID-19 and related pathophysiology. OBJECTIVES: To describe patterns of testing for anti-platelet factor 4 (PF4) antibodies using various ELISA assays in a large Australian cohort and comparative functional platelet activation assays in a subset. PATIENTS/METHODS: Asserachrom HPIA IgG ELISA was performed in 1284 patients over a period of 12 months, supplemented in select cohorts by comparative ELISA using three other methods (n = 78-179), three different functional assays (flow cytometry, serotonin release assay, and/or Multiplate; n = 476), and rapid immunological chemiluminescence anti-PF4 assay (n = 460), in a multicenter study. RESULTS: For first episode presentations, 190/1284 (14.8%) ELISA tests were positive. Conversely, most (445/460; 96.7%) chemiluminescence anti-PF4 test results were negative. All functional assays showed associations of higher median ELISA optical density with functional positivity and with high rates of ELISA positivity (64.0% to 85.2%). Data also identified functional positivity in 14.8%-36.0% of ELISA negative samples, suggesting false negative VITT by HPIA IgG ELISA in upward of one third of assessable cases. CONCLUSION: To our knowledge, this is the largest multicenter evaluation of anti-PF4 testing for investigation of VITT. Discrepancies in test results (ELISA vs. ELISA or ELISA vs. functional assay) in some patients highlighted limitations in relying on single methods (ELISA and functional) for PF4 antibody detection in VITT, and also highlights the variability in phenotypic test presentation and pathomechanism of VITT.


Assuntos
COVID-19 , Trombocitopenia , Trombose , Vacinas , Humanos , Fator Plaquetário 4 , Heparina/efeitos adversos , Austrália , Trombocitopenia/induzido quimicamente , Trombocitopenia/diagnóstico , Trombose/diagnóstico , Fatores Imunológicos/efeitos adversos , Imunoglobulina G
4.
Florianópolis; Secretaria de Estado da Saúde; 2022. 33 p il. color..
Monografia em Português | LILACS, CONASS, ColecionaSUS, SES-SC | ID: biblio-1415281

RESUMO

Este relatório refere-se à análise crítica dos documentos apresentados pelo CRIE/DIVE/SES/SC para a elaboração de um Protocolo Estadual de atendimento para casos de Síndrome de Trombose com Trombocitopenia (STT) associada à vacinação com vacinas de vetor de adenovírus não replicante contra a COVID-19, baseados na Nota Técnica CGPNI/DEIDT/SVS/MS nº 933/2021. Na Nota Técnica emitida pelo Ministério da Saúde consta uma breve contextualização, a investigação da STT, protocolo de investigação laboratorial, manejo clínico de casos e definição de casos para investigação de STT. O documento enviado pelo CRIE/DIVE/SES/SC intitulado "Fluxograma de Atendimento TTS" apresentou os dados da nota supracitada resumidos com a adição de um fluxograma de atendimento hospitalar. Este relatório visa avaliar e emitir um parecer técnico embasado em evidências científicas sobre a disponibilização dos medicamentos Imunoglobulina Humana intravenosa (IGHIV) e Rivaroxabana para o tratamento de STT, fluxo de aces o aos medicamentos e avaliação do impacto orçamentário, para posterior elaboração de um Protocolo Estadual para esta síndrome, destinado aos profissionais da saúde, pacientes e gestores do estado de Santa Catarina.


Assuntos
Humanos , Trombocitopenia/induzido quimicamente , Trombose/induzido quimicamente , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Síndrome , Trombocitopenia/diagnóstico , Trombocitopenia/tratamento farmacológico , Trombose/diagnóstico , Trombose/tratamento farmacológico , Protocolos Clínicos
5.
Int J Lab Hematol ; 43(6): 1599-1605, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34275201

RESUMO

INTRODUCTION: Management of patients with suspected heparin-induced thrombocytopenia (HIT) can lead to significant costs. Reported cost-saving initiatives have focused on minimizing inappropriate testing in low-risk patients and optimizing alternative anticoagulant selection. We sought to further investigate how utilizing various HIT laboratory testing models would impact total cost of testing and alternative anticoagulant use. METHODS: Utilizing a retrospective cohort of adult patients tested for HIT over three years within our institution, we evaluated how utilization of four distinct laboratory models impacted total number of HIT test combinations completed, time to HIT testing finalization, percentage of patients discharged from the hospital prior to HIT testing finalization, total alternative anticoagulant days, and total anticipated major bleed events. Additionally, we calculated cost of laboratory testing and alternative anticoagulant associated with each model. RESULTS: A total of 482 patients were included in our cohort. A laboratory testing model that utilized an in-house platelet factor 4 (PF4)-heparin enzyme-linked immunosorbent assay (ELISA) completed three days weekly, and reflex serotonin release assay (SRA) with a five-day turnaround resulted in the shortest mean time to HIT testing finalization, lowest percentage of patients discharged prior to HIT testing finalization, and lowest total alternative anticoagulant days. CONCLUSIONS: Institutions should evaluate current HIT laboratory testing practices and assess for opportunities for optimization. Testing models utilizing a PF4-heparin antibody ELISA with a reflex SRA for positive results may improve testing metrics and lead to lower utilization of alternative anticoagulants.


Assuntos
Anticoagulantes/efeitos adversos , Testes de Coagulação Sanguínea/economia , Redução de Custos , Custos e Análise de Custo , Heparina/efeitos adversos , Trombocitopenia/diagnóstico , Trombocitopenia/etiologia , Coagulação Sanguínea , Testes de Coagulação Sanguínea/métodos , Análise Custo-Benefício , Gerenciamento Clínico , Suscetibilidade a Doenças , Ensaio de Imunoadsorção Enzimática/economia , Ensaio de Imunoadsorção Enzimática/métodos , Humanos , Trombocitopenia/sangue , Trombocitopenia/terapia
6.
J Thromb Haemost ; 19(9): 2263-2267, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34227230

RESUMO

BACKGROUND: Vaccine-induced immune thrombocytopenia and thrombosis (VITT) following the administration of the AstraZeneca (AZ) ChAdOx1 nCOV-19 vaccine has recently been reported. The associated clinical and laboratory features have included thrombosis at unusual sites, thrombocytopenia, and raised D-dimers with positivity for IgG anti-platelet factor 4 (PF4) antibodies. OBJECTIVES: A UK National External Quality Control Assessment Scheme external quality control exercise was carried out by distributing liquid and lyophilized samples from a subject with VITT, a pool of samples from subjects with classical heparin-induced thrombocytopenia (HIT), and a non-VITT/non-HIT case to 85 centers performing HIT testing. METHODS: Participating centers employed their locally validated testing methods for HIT assays. RESULTS: The lyophilized and liquid samples were found to be commutable for the ELISA assays used in the detection of anti-PF4 antibodies. The Aeskulisa, Stago, Hyphen, and LIFECODES anti-PF4 ELISA assays successfully detected the VITT antibody, whereas the Acustar HIT, Werfen LIA, and the Stago STIC assays did not. CONCLUSION: It is important that clinical and laboratory teams are aware of the limitations of some anti-PF4 assays when using them to aid diagnosis of VITT syndrome.


Assuntos
Púrpura Trombocitopênica Idiopática , Trombocitopenia , Trombose , Vacinas , Vacinas contra COVID-19 , ChAdOx1 nCoV-19 , Heparina/efeitos adversos , Humanos , Fator Plaquetário 4 , Púrpura Trombocitopênica Idiopática/induzido quimicamente , Púrpura Trombocitopênica Idiopática/diagnóstico , Trombocitopenia/induzido quimicamente , Trombocitopenia/diagnóstico , Reino Unido
7.
Eur J Haematol ; 107(2): 173-180, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33987882

RESUMO

Very rare cases of thrombosis associated with thrombocytopenia have occurred following the vaccination with AstraZeneca COVID-19 vaccine. The aim of this concise review is to summarize the current knowledge on the epidemiologic and pathogenic mechanisms of this syndrome named vaccine-associated immune thrombosis and thrombocytopenia (VITT). A practical patient management section will also be dealt with using information available from national and international scientific societies as well as expert panels. A literature search on the VITT syndrome was carried out in PubMed using appropriate MeSH headings. Overall, 40 VITT cases have been reported. Continuous pharmacovigilance monitoring is needed to collect more data on the real incidence and the pathogenesis of VITT syndrome. Such information will also help us to optimize the management this rare but often clinically severe thrombotic condition associated with COVID-19 vaccination.


Assuntos
Vacinas contra COVID-19/efeitos adversos , COVID-19/complicações , SARS-CoV-2 , Trombocitopenia/etiologia , Trombose/etiologia , Biomarcadores , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/imunologia , Efeitos Psicossociais da Doença , Gerenciamento Clínico , Suscetibilidade a Doenças , Humanos , Avaliação de Resultados da Assistência ao Paciente , Medição de Risco , Fatores de Risco , SARS-CoV-2/imunologia , Índice de Gravidade de Doença , Síndrome , Trombocitopenia/diagnóstico , Trombocitopenia/epidemiologia , Trombocitopenia/terapia , Trombose/diagnóstico , Trombose/epidemiologia , Trombose/terapia
8.
Thromb Res ; 202: 125-127, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33831665

RESUMO

The diagnosis of immune thrombocytopenia (ITP) remains an exclusion, as a specific biomarker is missing. We aimed to investigate the diagnostic characteristics, establish a cut-off point for reticulated platelets, and compare it with the clinical exclusion diagnosis used in the assessment of ITP. Forty-one patients with ITP and 187 healthy individuals were enrolled in Santa Maria, Brazil. Sysmex XE-5000 was used to measure IPF. We obtained an IPF cut-off point of 6.3% with a sensitivity of 92.7% (95% CI: 80.1-98.5) and a specificity of 92.5% (95% CI: 87.8-95.8). The area under the curve was 0.97. The kappa coefficient was 0.85 (95% CI: 0.75-0.95), which shows high agreement between methods. The positive (PPV) and negative predictive values (NPV) were 81.25% and 96.42%, respectively. From the cut-off point, kappa index, PPV, and NPV obtained, it is possible to conclude that IPF can be an efficient laboratory marker for diagnosing ITP.


Assuntos
Púrpura Trombocitopênica Idiopática , Trombocitopenia , Plaquetas , Brasil , Humanos , Contagem de Plaquetas , Púrpura Trombocitopênica Idiopática/diagnóstico , Trombocitopenia/diagnóstico
9.
Pathology ; 53(2): 247-256, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33032809

RESUMO

Heparin induced thrombocytopenia (HIT) is a rare but potentially fatal complication of heparin therapy. In some patients, HIT causes platelet activation and thrombosis (sometimes abbreviated HITT), which leads to adverse clinical sequalae ('pathological HIT'). The likelihood of HIT is initially assessed clinically, typically using a scoring system, of which the 4T score is that most utilised. Subsequent laboratory testing to confirm or exclude HIT facilitates exclusion or diagnosis and management. The current investigation comprises a multicentre (n=9) assessment of contemporary laboratory testing for HIT, as performed over the past 1-3 years in each site and comprising testing of over 1200 samples. The primary laboratory test used by study participants (n=8) comprised a chemiluminescence procedure (HIT-IgG(PF4-H)) performed on an AcuStar instrument. Additional immunological testing performed by study sites included lateral flow (STiC, Stago), enzyme linked immunosorbent assay (ELISA), Asserachrom (HPIA IgG), PaGIA (BioRad), plus functional assays, primarily serotonin release assay (SRA) or platelet aggregation methods. The chemiluminescence procedure yielded a highly sensitive screening method for identifying functional HIT, given high area under the curve (AUC, generally ≥0.9) in a receiver operator characteristic (ROC) analysis against SRA as gold standard. ELISA testing resulted in lower ROC AUC scores (<0.8) and higher levels of false positives. Although there is clear association with the likelihood of HIT, the 4T score had less utility than literature suggests, and was comparable to a previous study reported by some of the authors.


Assuntos
Testes Diagnósticos de Rotina/métodos , Heparina/efeitos adversos , Trombocitopenia/diagnóstico , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Ensaio de Imunoadsorção Enzimática , Feminino , Heparina/uso terapêutico , Humanos , Laboratórios Hospitalares , Masculino , Agregação Plaquetária , Curva ROC , Trombocitopenia/etiologia , Trombose/induzido quimicamente
10.
Vasc Med ; 25(2): 160-173, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32195628

RESUMO

Heparin-induced thrombocytopenia (HIT) is a life and limb-threatening complication of heparin exposure. Here, we review the pathogenesis, incidence, diagnosis, and management of HIT. The first step in thwarting devastating complications from this entity is to maintain a high index of clinical suspicion, followed by an accurate clinical scoring assessment using the 4Ts. Next, appropriate stepwise laboratory testing must be undertaken in order to rule out HIT or establish the diagnosis. In the interim, all heparin must be stopped immediately, and the patient administered alternative anticoagulation. Here we review alternative anticoagulation choice, therapy alternatives in the difficult-to-manage patient with HIT, and the problem of overdiagnosis.


Assuntos
Anticoagulantes/efeitos adversos , Substituição de Medicamentos , Heparina/efeitos adversos , Trombocitopenia , Técnicas de Apoio para a Decisão , Diagnóstico Diferencial , Humanos , Incidência , Valor Preditivo dos Testes , Prognóstico , Fatores de Risco , Trombocitopenia/induzido quimicamente , Trombocitopenia/diagnóstico , Trombocitopenia/epidemiologia , Trombocitopenia/terapia
12.
Blood ; 135(14): 1171-1184, 2020 04 02.
Artigo em Inglês | MEDLINE | ID: mdl-31945147

RESUMO

Prompt diagnostic evaluation of suspected heparin-induced thrombocytopenia (HIT) is critical for guiding initial patient management. We assessed the performance of 3 immunoassays detecting anti-platelet factor 4 (PF4)/heparin antibodies, derived a diagnostic algorithm with a short analytical turnaround time (TAT), and prospectively validated the algorithm. Plasma samples were analyzed by Zymutest-HIA-IgG, HemosIL-AcuStar-HIT-IgG, and ID-H/PF4-PaGIA in retrospective (n = 221) and prospective (n = 305) derivation cohorts. We calculated likelihood ratios of result intervals and cutoff values with 100% negative (NPV) and positive (PPV) predictive values for a positive gold standard functional assay (heparin-induced platelet activation [HIPA]). A diagnostic algorithm was established based on the Bayesian combination of pretest probability and likelihood ratios of first- and second-line immunoassays. Cutoffs with 100% PPV for positive HIPA were >3.0 U/mL (HemosIL-AcuStar-HIT-IgG) and titer ≥16 (ID-H/PF4-PaGIA); cutoffs with 100% NPV were <0.13 U/mL and ≤1, respectively. During the prospective validation of the derived algorithm (n = 687), HemosIL-AcuStar-HIT-IgG was used as unique testing in 566 (82.4%) of 687 cases (analytical TAT, 30 minutes). In 121 (17.6%) of 687 unresolved cases, ID-H/PF4-PaGIA was used as second-line testing (additional TAT, 30 minutes). The algorithm accurately predicted HIT in 51 (7.4%) of 687 patients and excluded it in 604 (87.9%) of 687 patients, leaving only 20 (2.9%) cases unresolved. We also identified 12 (1.7%) of 687 positive predictions not confirmed by HIPA: 10 patients with probable HIT despite negative HIPA and 2 possible false-positive algorithm predictions. The combination of pretest probability with first- and second-line immunoassays for anti-PF4/heparin antibodies is accurate for ruling in or out HIT in ≥95% of cases within 60 minutes. This diagnostic approach improves initial management of patients with suspected HIT.


Assuntos
Anticorpos/sangue , Anticoagulantes/efeitos adversos , Heparina/efeitos adversos , Trombocitopenia/induzido quimicamente , Trombocitopenia/diagnóstico , Idoso , Anticorpos/imunologia , Anticoagulantes/imunologia , Teorema de Bayes , Ensaio de Imunoadsorção Enzimática/economia , Ensaio de Imunoadsorção Enzimática/métodos , Feminino , Heparina/imunologia , Humanos , Imunoensaio/economia , Imunoensaio/métodos , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Masculino , Fator Plaquetário 4/imunologia , Estudos Prospectivos , Estudos Retrospectivos , Sensibilidade e Especificidade , Trombocitopenia/sangue , Fatores de Tempo
13.
J Thromb Thrombolysis ; 50(1): 195-200, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31802415

RESUMO

Heparin-induced thrombocytopenia (HIT) is a rare adverse drug reaction. The anti-PF4 antibody assay (ELISA) is utilized to assist in the clinical evaluation of HIT due to its high negative predictability and wide-spread availability. However, it also associated with false positive results. The 4T score can assist in predicting an individual's risk for HIT and the need for further laboratory testing. This was a single-center prospective observational cohort study. Orders for HIT testing were sent via page to a clinical pharmacist to calculate a 4T score. If low risk, the pharmacist contacted the ordering prescriber to recommend discontinuation of laboratory testing. During the study, a clinical support tool was implemented to assist prescribers with ordering HIT tests. The study was divided into a pharmacist intervention group and a control group. A total of 303 pages were received. One hundred nine were missed due to unavailability of the pharmacist at time of page. A pharmacist reviewed 194 pages and intervened on 132. One hundred seven were scored as low risk, 70 as intermediate risk and 9 as high risk. Pharmacist intervention resulted in discontinuing 64 ELISA and 11 serotonin release assay tests. The clinical support tool resulted in a yearly decrease of HIT testing by 27%. Laboratory cost savings totaled $11,000 but did not include avoidance of laboratory technician or drug cost. Pharmacist involvement in the clinical assessment of HIT and the use of a support tool resulted in the reduction of HIT tests in low risk patients.


Assuntos
Anticorpos/análise , Heparina/efeitos adversos , Farmacêuticos , Fator Plaquetário 4/imunologia , Utilização de Procedimentos e Técnicas , Trombocitopenia , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Redução de Custos/métodos , Feminino , Heparina/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Utilização de Procedimentos e Técnicas/economia , Utilização de Procedimentos e Técnicas/estatística & dados numéricos , Papel Profissional , Melhoria de Qualidade , Gestão de Riscos/métodos , Trombocitopenia/sangue , Trombocitopenia/induzido quimicamente , Trombocitopenia/diagnóstico , Trombocitopenia/prevenção & controle , Estados Unidos
14.
Eur J Clin Microbiol Infect Dis ; 39(3): 527-538, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31853741

RESUMO

Linezolid is an antibiotic used against gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. Its primary adverse effect is haematotoxicity. The objective of this study was to analyse the risk factors for onset of thrombocytopenia in critically ill patients treated with linezolid. This was a retrospective, single-centre study of 72 patients. Platelets were measured from D0 to D20 after the start of treatment. The risk factors for thrombocytopenia were identified using a multivariate logistic regression analysis following a Monte Carlo simulation. Following ROC curve analysis, a baseline platelet count lower than 108 × 109/L and a Cmin higher than 4 mg/L, with respective odds ratios of 117 (95% CI [97-206]) and 3 (95% CI [1.5-6.2]) in the simulated population, were identified as risk factors. Among the source population patients combining these 2 factors, a significantly higher number developed thrombocytopenia (66.7% vs. 33.3%, p = 0.0042). A baseline platelet count lower than 108 × 109/L and a Cmin higher than 4 mg/L are risk factors for the onset of thrombocytopenia in critically ill patients treated with linezolid.


Assuntos
Antibacterianos/efeitos adversos , Estado Terminal , Linezolida/efeitos adversos , Trombocitopenia/epidemiologia , Trombocitopenia/etiologia , Adulto , Idoso , Antibacterianos/uso terapêutico , Feminino , Humanos , Linezolida/farmacocinética , Linezolida/uso terapêutico , Masculino , Pessoa de Meia-Idade , Método de Monte Carlo , Contagem de Plaquetas , Curva ROC , Medição de Risco , Fatores de Risco , Trombocitopenia/diagnóstico
15.
J Thromb Haemost ; 17(12): 2123-2130, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31420903

RESUMO

BACKGROUND: Accurate diagnosis of heparin-induced thrombocytopenia (HIT) is essential to ensure timely treatment and prevent complications. Current diagnostic assays include enzyme-linked immunosorbent assays (ELISAs) and rapid immunoassays (RIs). RIs offer fast turnaround times but were not significantly represented in previous external proficiency testing challenges. OBJECTIVES: To use external proficiency testing to assess qualitative concordance for heparin/PF4 antibody detection. METHODS: From 2013 to 2017, the External Quality Control for Assays and Tests (ECAT) Foundation distributed 10 samples internationally. RESULTS: In total, 437 laboratories submitted 3149 results. ELISAs accounted for 1484 (47%) responses with RIs accounting for 1665 (53%) responses. RI use increased over the 5-year period. ELISAs classified 96% of both consensus positive and consensus negative samples concordantly. The coefficient of variation (CV) for positive sample optical densities (ODs) ranged from 35% to 50% when combining ELISA assay methods together. Quantitative RIs classified 97% of consensus-positive and 98% of consensus-negative samples concordantly. Qualitative RIs had a higher proportion of discordant responses and classified 88% of consensus-positive samples and 73% of consensus-negative samples concordantly. Of RIs only latex immunoassays and IgG specific chemiluminescent assays identified > 95% of samples concordantly with consensus. CONCLUSION: Quantitative RIs and ELISAs classify > 95% of samples concordantly. The ODs from different ELISA methods vary considerably and are not interchangeable. Qualitative RI use is increasing despite a greater proportion of discordant classifications. This includes a higher than expected number of negative classifications for consensus-positive samples among many RIs, challenging their use as "rule out" tests.


Assuntos
Anticorpos/sangue , Anticoagulantes/efeitos adversos , Ensaio de Imunoadsorção Enzimática/normas , Heparina/efeitos adversos , Ensaio de Proficiência Laboratorial , Fator Plaquetário 4/imunologia , Radioimunoensaio/normas , Testes Sorológicos/normas , Trombocitopenia/diagnóstico , Anticoagulantes/imunologia , Austrália , Biomarcadores/sangue , Europa (Continente) , Heparina/imunologia , Humanos , Israel , América do Norte , Variações Dependentes do Observador , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Trombocitopenia/sangue , Trombocitopenia/induzido quimicamente , Trombocitopenia/imunologia
16.
J Thromb Haemost ; 17(3): 525-531, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30640980

RESUMO

Essentials A pilot study for External Quality Assessment for testing of HIT is described. The qualitative accordance for the PF4/heparin IgG test was 97.6%. The qualitative accordance for functional HIT tests was considerably lower. External Quality Assessment for functional HIT tests is required. SUMMARY: Objective Heparin-induced thrombocytopenia (HIT) is a potentially life-threatening complication of heparin exposure. Diagnosis is most reliable using a combination of an enzyme immunoassay (EIA) that detects antibodies against platelet factor 4 (PF4)/heparin complexes ("antigen" assay) and a "functional" assay that detects platelet-activating properties of the pathogenic HIT antibodies. No External Quality Assessment (EQA) is available for a combination of the tests. Here we report on the results of the first international EQA. Methods The pilot EQA was organized by the Department of Transfusion Medicine, Universitätsmedizin Greifswald, Germany. Six serum samples of patients, which were referred to Greifswald for HIT diagnosis, and one negative control sample were distributed to seven participants in Germany, Canada, and Singapore. Participants were asked to report the optical density (OD) values of their local EIA test for IgG-specific antibodies against the PF4/heparin complexes and the results for a functional assay (HIPA or SRA). Consensus was defined as a minimum 70% agreement, i.e., agreement among at least five of the seven participating laboratories. Results and conclusion Six out of seven participants reported results for EIA, with a high quantitative accordance (97.6%). For the functional assay, consensus was reached for all samples except the negative control, for which some participants reported nonspecific reactivity. All HIT-negative samples were correctly diagnosed by all participants; for HIT-positive samples, consensus of 70% was reached. Although the limited availability of sample material is an obstacle to overcome, an EQA combining both EIA and functional testing is feasible.


Assuntos
Anticorpos/sangue , Anticoagulantes/efeitos adversos , Heparina/efeitos adversos , Imunoglobulina G/sangue , Testes Imunológicos/normas , Fator Plaquetário 4/imunologia , Trombocitopenia/diagnóstico , Idoso , Anticoagulantes/imunologia , Biomarcadores/sangue , Canadá , Feminino , Alemanha , Heparina/imunologia , Humanos , Ensaio de Proficiência Laboratorial , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Projetos Piloto , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Singapura , Trombocitopenia/sangue , Trombocitopenia/induzido quimicamente , Trombocitopenia/imunologia
17.
J Thromb Haemost ; 17(2): 383-388, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30552743

RESUMO

Essentials Current risk scores for heparin-induced thrombocytopenia (HIT) are not computer-friendly. We compared a new computerized risk score with the 4Ts score in a large healthcare system. The computerized risk score agrees with the 4Ts score 85% of the time. The new score could potentially improve HIT diagnosis via incorporation into decision support. SUMMARY: Background (HIT) is an immune-mediated adverse drug event associated with life-threatening thrombotic complications. The 4Ts score is widely used to estimate the risk for HIT and guide diagnostic testing, but it is not easily amenable to computerized clinical decision support (CDS) implementation. Objectives Our main objective was to develop an HIT computerized risk (HIT-CR) scoring system that provides platelet count surveillance for timing and degree of thrombocytopenia to identify those for whom diagnostic testing should be considered. Our secondary objective was to evaluate clinical management and subsequent outcomes in those identified as being at risk for HIT. Methods We retrospectively analyzed data from a stratified sample of 150 inpatients treated with heparin to compare the performance of the HIT-CR scoring system with that of a clinically calculated 4Ts score. We took a 4Ts score of ≥ 4 as the gold standard to determine whether HIT diagnostic testing should be performed. Results The best cutoff point of the HIT-CR score was a score of 3, which yielded 85% raw agreement with the 4Ts score and a kappa of 0.69 (95% confidence interval 0.57-0.81). Ninety per cent of patients with 4Ts score of ≥ 4 failed to undergo conventionally recommended diagnostic testing; 38% of these experienced persistent, unexplained thrombocytopenia, and 4% suffered life-threatening thrombotic complications suggestive of undiagnosed HIT. Conclusion The HIT-CR scoring system is practical for computerized CDS, agrees well with the 4Ts score, and should be prospectively evaluated for its ability to identify patients who should be tested for HIT.


Assuntos
Anticoagulantes/efeitos adversos , Plaquetas/efeitos dos fármacos , Simulação por Computador , Técnicas de Apoio para a Decisão , Heparina/efeitos adversos , Contagem de Plaquetas , Trombocitopenia/induzido quimicamente , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Registros Eletrônicos de Saúde , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Valor Preditivo dos Testes , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Trombocitopenia/sangue , Trombocitopenia/diagnóstico , Adulto Jovem
18.
J Thromb Thrombolysis ; 45(1): 130-134, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29185142

RESUMO

Many medical centers are faced with a major challenge in making an accurate diagnosis of heparin-induced thrombocytopenia (HIT) and ensuring appropriate changes in management strategy in line with guideline recommendations. We report the initial and long-term impact and challenges of institution-wide changes in the diagnosis and management of HIT in the inpatient setting at an academic medical center. We established a HIT Task Force, consisting of a multidisciplinary team of non-malignant hematologists, nursing, pharmacist, pathology, blood bank and clinical lab informatics. Changes were implemented from 2011 to 2012. In 2013, testing for PF4 and SRA decreased by 37.5 and 85%, respectively. 100% of positive PF4 received an automatic hematology consult to guide management, leading to a 78% reduction in the use of direct thrombin inhibitors. Annual audits in the subsequent years demonstrated increasing testing for HIT due to changes in the electronic ordering system. Through continuous monitoring, these shortfalls were detected and intervene early on with continued success. The implementation of a centralized hospital-wide protocol via a multidisciplinary task force that coordinates testing and treatment of patients suspected of having HIT led to a substantial reduction in PF4 and SRA testing, as well as use of DTIs, resulting in a safe and cost-effective approach for the diagnosis and treatment of HIT. Our study highlights the important of continuous monitoring to maintain the improvements made. Despite our initial success, annual re-auditing allowed for early detection of challenges, which then allowed appropriate early intervention.


Assuntos
Comitês Consultivos , Heparina/efeitos adversos , Trombocitopenia/diagnóstico , Análise Custo-Benefício , Gerenciamento Clínico , Humanos , Fator Plaquetário 4 , Trombocitopenia/induzido quimicamente , Fatores de Tempo
19.
J Am Heart Assoc ; 6(12)2017 Dec 04.
Artigo em Inglês | MEDLINE | ID: mdl-29203580

RESUMO

BACKGROUND: Postoperative thrombocytopenia has been reported to be correlated with adverse events, but the prognostic value of baseline thrombocytopenia is unclear. This study was undertaken to evaluate the relationship between preoperative thrombocytopenia and adverse outcomes in patients with rheumatic heart disease who underwent valve replacement surgery. METHODS AND RESULTS: A total of 1789 patients with rheumatic heart disease undergoing valve replacement surgery were consecutively enrolled and postoperatively followed up for 1 year. Patients were stratified on the basis of presence (n=495) or absence (n=1294) of thrombocytopenia (platelet count, <150×109/L), according to hospital admission platelet counts. During the hospitalization period, 69 patients (3.9%) died. The in-hospital all-cause mortality rate was significantly higher in the thrombocytopenic group (6.9% versus 2.7%; P<0.001). Multivariate analyses revealed that thrombocytopenia was independently associated with in-hospital all-cause mortality (odds ratio, 2.21; 95% confidence interval, 1.29-3.80; P=0.004). Platelet counts could predict in-hospital all-cause mortality for patients both with and without previous atrial fibrillation (areas under the curve, 0.708 [P<0.001] and 0.610 [P=0.025], respectively). One-year survival was significantly lower in patients with thrombocytopenia compared with controls (91.3% versus 96.1%; log-rank=14.65; P<0.001). In addition, thrombocytopenia was an independent predictor for postoperative 1-year all-cause mortality in multivariate Cox regression analysis. CONCLUSIONS: Platelet counts, as simple and inexpensive indexes, were reliable to be used as a preoperative risk assessment tool for patients with rheumatic heart disease undergoing valve replacement surgery.


Assuntos
Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Cardiopatia Reumática/cirurgia , Trombocitopenia/complicações , Área Sob a Curva , Distribuição de Qui-Quadrado , Feminino , Doenças das Valvas Cardíacas/complicações , Doenças das Valvas Cardíacas/diagnóstico , Doenças das Valvas Cardíacas/mortalidade , Implante de Prótese de Valva Cardíaca/mortalidade , Mortalidade Hospitalar , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Contagem de Plaquetas , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Curva ROC , Estudos Retrospectivos , Cardiopatia Reumática/complicações , Cardiopatia Reumática/diagnóstico , Cardiopatia Reumática/mortalidade , Medição de Risco , Fatores de Risco , Trombocitopenia/sangue , Trombocitopenia/diagnóstico , Trombocitopenia/mortalidade , Fatores de Tempo , Resultado do Tratamento
20.
Am J Clin Pathol ; 148(5): 390-397, 2017 Nov 02.
Artigo em Inglês | MEDLINE | ID: mdl-29059268

RESUMO

OBJECTIVES: We implemented a policy of reflex serotonin-release assay (SRA) testing for all patients with a positive heparin-induced thrombocytopenia (HIT) immunoassay. METHODS: We identified all patients who had SRA testing sent as a consequence of a positive HIT immunoassay test. We reviewed charts of patients to calculate the 4Ts clinical score, determined the effect of testing on clinical management, and documented the change in utilization of direct thrombin inhibitors (DTIs). RESULTS: The likelihood of a positive SRA varied with the optical density (OD) of the immunoassay. The performance of the immunoglobulin G (IgG)-specific and polytypic enzyme-linked immunosorbent assay was not statistically different. Both OD and 4Ts score correlated with the likelihood of a positive SRA but demonstrated poor specificity. Discontinuation of DTIs in patients with negative SRAs resulted in decreased drug utilization. CONCLUSIONS: The IgG-specific HIT immunoassay OD correlates with the likelihood of a positive SRA but does not achieve high specificity. The reflex testing algorithm allows for definitive classification of patients, and the cost of such a reflex testing program may be offset by decreased utilization of DTIs.


Assuntos
Algoritmos , Testes Hematológicos , Trombocitopenia/diagnóstico , Anticoagulantes/efeitos adversos , Testes Hematológicos/economia , Testes Hematológicos/métodos , Heparina/efeitos adversos , Humanos , Imunoensaio , Ativação Plaquetária , Serotonina/metabolismo
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