scholarly journals Performance of the New Automated Latex Immunoturbidometric Assay in the Diagnosis of Heparin Induced Thrombocytopenia: A Single Institution Experience

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4689-4689
Author(s):  
Sriman Swarup ◽  
Somedeb Ball ◽  
Nimesh Adhikari ◽  
Anita Sultan ◽  
Khatrina Swarup ◽  
...  

Introduction: Heparin induced thrombocytopenia (HIT) is a severe prothrombotic condition, usually triggered by exposure to heparin products. It is characterized by platelet activation induced by the formation of antibodies to the platelet factor 4 (PF4)/ heparin polyanion complexes. Diagnostic algorithm includes clinical scoring (4T score) alongside serological test for detection of these antibodies (HIT-Ab), while serotonin release assay (SRA) remains the gold- standard for confirmation. The automated latex immunoturbidometric assay (LIA) has recently been FDA approved as a screening tool for HIT and is a potential alternative to the conventional particle immunofiltration assay (PIFA) for time-sensitive detection of HIT-Ab to guide treatment considerations. We recently introduced LIA in our institution. In this study, we present our experience with LIA in comparison to PIFA in the diagnosis of HIT. Methods: We retrospectively reviewed the charts of all the patients on whom a PIFA was ordered between March 2017 and March 2018 in our hospital. We collected information on the results of the PIFA and SRA (if available). We replaced PIFA with LIA for HIT screening. Then, we introduced a structured protocol for diagnosis of HIT in our institution by incorporating 4T scoring alongside LIA order in the electronic medical record (EMR), in December 2018. We reviewed the EMR of all the patients on whom HIT-Ab test (LIA) was ordered between January and June of 2019, and collected similar information as before. All the data were compiled in a single master excel sheet for calculation of performance characteristics (sensitivity, specificity, positive and negative predictive values) for both PIFA and LIA. A patient was considered to have the diagnosis of HIT if the result of SRA was available and positive. Results: In the first phase, a total of 31 orders for SRA was noted against 170 PIFA orders. Five patients had a positive SRA, of whom two were PIFA negative. Half the patients with a negative SRA result were positive for PIFA. Hence, the sensitivity and specificity of PIFA test for our study population were noted to be 60% and 50%, respectively. PIFA had a positive predictive value (PPV) of mere 18.75% for the diagnosis of HIT, whereas the negative predictive value (NPV) was found to be 86.66%. Introduction of structured protocol for HIT diagnosis substantially reduced the number of inappropriate SRA orders in the second phase. On review of data for six months with the new HIT-Ab test LIA, SRA was ordered in only eight patients, to go with 69 orders for the LIA. The result of LIA was positive in all three patients with a positive SRA, whereas it was false positive in four instances. Only one patient was negative for both LIA and SRA during this period. LIA was found to be 100% sensitive and 20% specific for the diagnosis of HIT in our sample. PPV and NPV for LIA were 42.85% and 100%, respectively. Conclusion: The sensitivity and specificity of LIA were found to be 100% and 20%, respectively, in our study population, which is different from the earlier report (Warkentin et al. 2017). The small sample size is a limitation of our study. Higher PPV and NPV for LIA, with its quick turnaround time, make it a useful alternative for the time-sensitive determination of post-test probability for HIT in patients. [HIT- Ab- Heparin Induced Thrombocytopenia Antibody, PIFA- Particle Immunofiltration Assay, LIA- Latex Immunoturbidometric Assay, SRA- Serotonin Release Assay, +ve- Positive, -ve - Negative, PPV- Positive Predictive Value, NPV- Negative Predictive Value] Disclosures No relevant conflicts of interest to declare.

2021 ◽  
pp. 106002802110387
Author(s):  
Long To ◽  
Dana Attar ◽  
Brittany Lines ◽  
Melissa McCarty ◽  
Hassan Nemeh ◽  
...  

Background: Heparin exposure and device-related thrombocytopenia complicate the diagnosis of heparin-induced thrombocytopenia (HIT) in patients receiving mechanical circulatory support (MCS). To improve anticoagulation management for patients with newly implanted MCS devices, incidence of confirmed HIT needs to be further characterized. Objectives: The purpose of this study is to describe the incidence of HIT and clinical utility of the 4Ts score in patients with newly implanted MCS devices. Methods: This is a retrospective analysis of MCS patients receiving unfractionated heparin from 2014 to 2017. The primary end point was incidence of laboratory-confirmed HIT. Strong positive, likely positive, low probability, and negative HIT categories were established based on heparin-induced platelet antibody (HIPA) and serotonin release assay (SRA). Secondary end points include characterization of platelet trends, argatroban use, incidence of HIT among each of the MCS devices, and utility of 4Ts score. Results: A total of 342 patient encounters met inclusion criteria, of which 68 HIPA tests and 25 SRAs were ordered. The incidence of HIT was 0.88% (3/342) and 4.4% (3/68) in patients with suspected HIT. Of the 68 HIPA tests, 3 (4.4%) were considered strong positive and 3 of the 25 SRAs were positive. Median 4Ts score was 4 [2.5-4] and optical density 0.19 [0.11-0.54]. The positive predictive value for the 4Ts score was 0.15 (CI = 0.03-0.46) and negative predictive value, 0.93 (CI = 0.82-0.98). Conclusion and Relevance: HIT occurs infrequently with newly implanted MCS devices. The 4Ts score appears to have a high negative predictive value for ruling out HIT.


Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4198-4198 ◽  
Author(s):  
Nikhil Mukhi ◽  
Sabina Saakova ◽  
Vaibhav Verma ◽  
Gurinder Sidhu

Abstract Background: Heparin-induced thrombocytopenia (HIT) is a pro-thrombotic and potentially lethal disorder caused by platelet-, endothelial-, and monocyte-activating antibodies that target multimolecular complexes of platelet factor 4 (PF4) and heparin. HIT is reported to occur in 0.2% to 5% of heparin-treated adults. Due to the diagnostic dilemma posed by the disease, various pre-test probability systems have been proposed. The most widely used 4Ts score has demonstrated high sensitivity but is limited by observer bias and its limited utility for intermediate scores. The anti-PF4/heparin antibody testing has sensitivity close to 100%, but its poor positive predictive value, low specificity and long turnaround time may lead to misdiagnosis and unnecessary treatment. Hence functional assays like 14C-serotonin release assay (SRA) are used for confirmation of diagnosis. These tests are highly specific for diagnosis but their use is restricted to a small number of reference laboratories. In this study, we describe a phenomenon which is seen in HIT patients and will help to improve the positive predictive value of 4T score. Hypothesis: Initial heparin exposure leads to a transient decrease in platelet count(less than 50% from presentation) which recovers close to baseline in a few days. Recovery from the transient drop is followed by a steeper drop in platelet count. This second substantial decline in platelet count is characteristic of HIT. Methods and objectives: We screened all hospitalized patients from 2008-2013 with ICD9 code for HIT (289.84) at discharge from Kings County Hospital and SUNY Downstate. One hundred fifty four patients were screened. Only patients with positive anti-PF4/heparin antibody test (HAT) and 14C-serotonin release assay (SRA) were included in the study. Results: Of the 154 patients, 54 patients had a positive HAT; 11 had positive HAT and SRA. Of the 11 patients included in the study, 4 (36.4%) were on VTE prophylaxis with unfractionated heparin (UFH), 6 (54.5%) were on UFH drip and 1 (9%) was on therapeutic dose of Enoxaparin. Out of 11 patients (81.2%), 9 were male with a median age of 68. Ten out of 11 patients (91%) demonstrated the transient platelet-reduction phenomenon. The median platelet count for these patients on admission was 239k/µl. The initial decline was seen on day 4.5 (median) to nadir platelet count of 148K/µl (median) which signifies a 38% drop. Platelet count normalized to baseline by Day 7 to 245K/µl (median) which is a 39% recovery. The secondary drop occurred on median Day 14 to 68K/µl (median) which is a 68% reduction since the recovery. This secondary drop was uniformly associated with HIT. The data is demonstrated by means of a graph as shown below. Figure 1 One patient in the study did not demonstrate this phenomenon. He developed HIT on day 4 of UFH exposure which is suggestive of pre-formed antibodies. Data regarding patient's prior exposure couldn't be obtained. Figure 1. One patient in the study did not demonstrate this phenomenon. He developed HIT on day 4 of UFH exposure which is suggestive of pre-formed antibodies. Data regarding patient's prior exposure couldn't be obtained. Conclusion: The exact mechanism of this transient platelet-reduction phenomenon stays unclear. In this small retrospective analysis, however, we observed this phenomenon in 91% of patients. All patients in this study had intermediate 4Ts scores; hence there may be a utility of this phenomenon in guiding treatment. Given the small sample size of patients, it is difficult to extrapolate this data to the general population. A multicentric study with larger sample size may help us in determining the utility of this phenomenon as a supplement to 4T score for HIT. Disclosures No relevant conflicts of interest to declare.


2015 ◽  
Vol 51 (5) ◽  
pp. 306-310 ◽  
Author(s):  
Lauren Cunningham ◽  
Audrey Cook ◽  
Andrew Hanzlicek ◽  
Kenneth Harkin ◽  
Joseph Wheat ◽  
...  

The objective of this study was to evaluate the sensitivity and specificity of an antigen enzyme immunoassay (EIA) on urine samples for the diagnosis of histoplasmosis in dogs. This retrospective medical records review included canine cases with urine samples submitted for Histoplasma EIA antigen assay between 2007 and 2011 from three veterinary institutions. Cases for which urine samples were submitted for Histoplasma antigen testing were reviewed and compared to the gold standard of finding Histoplasma organisms or an alternative diagnosis on cytology or histopathology. Sensitivity, specificity, negative predictive value, positive predictive value, and the kappa coefficient and associated confidence interval were calculated for the EIA-based Histoplasma antigen assay. Sixty cases met the inclusion criteria. Seventeen cases were considered true positives based on identification of the organism, and 41 cases were considered true negatives with an alternative definitive diagnosis. Two cases were considered false negatives, and there were no false positives. Sensitivity was 89.47% and the negative predictive value was 95.35%. Specificity and the positive predictive value were both 100%. The kappa coefficient was 0.9207 (95% confidence interval, 0.8131–1). The Histoplasma antigen EIA test demonstrated high specificity and sensitivity for the diagnosis of histoplasmosis in dogs.


Author(s):  
Dr. Chaturbhuj Prasad Swarnkar ◽  
Dr. Shiv Raj Meena

Background- Rotator cuff tears are one of the most common causes of shoulder pain for which patients seek treatment. As in our daily work, the shoulder joint is the most frequently used, there is higher chance of having shoulder joint injury. The aim of the study is to compare the efficacy of MRI in diagnosing shoulder pathologies in comparison to arthroscopy, considering arthroscopy as the gold standard. Methods- 30 Patient with suspected rotator cuff injury patients, between 18-80 years of age was included in the study. MRI of the shoulder joint was done followed by shoulder arthroscopy. The data collected was analysed for the significant correlation between MRI of shoulder and arthroscopic findings by kappa statistics. Results- The accuracy of MRI in diagnosis of rotator cuff partial tears, was 90%, while sensitivity and specificity was 100.00%, 78.57% and positive predictive value was 84.21% and negative predictive value was 100.00% and accuracy of MRI in diagnosis of rotator cuff full tears, was 86.67%, while sensitivity and specificity was 63.64%, 100.00%) and positive predictive value was 100.00% and negative predictive value was 82.61% in our study. Conclusion- Our study demonstrates a high sensitivity and specificity for the MRI diagnosis of both partial and full thickness rotator cuff tears and good correlation with arthroscopic findings. Keywords: Rotator cuff, Shoulder pain, Arthroscopy, MRI.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4754-4754 ◽  
Author(s):  
Ravneet Thind ◽  
Danielle Heidemann ◽  
Sundara Raman ◽  
Philip Kuriakose

Introduction Heparin-induced thrombocytopenia (HIT) is a potentially fatal, thrombotic complication of heparin therapy mediated by antibodies to complexes between platelet factor 4 (PF4) and heparin. Accurate and rapid diagnosis with prompt commencement of therapy are imperative as delays in treatment are associated with an increasing risk of thrombosis, amputation, or death. On the flip side, initiation of therapy with direct thrombin inhibitors without laboratory confirmation carries a significant risk of bleeding. Two types of laboratory tests are available for detection of these antibodies: a widely available immunoassay (ELISA), which is very sensitive to the presence of anti-heparin/PF4 antibodies, but is less specific to the clinical syndrome of HIT because of detection of non-pathological antibodies. The Serotonin Release Assay (SRA) is a functional assay that is now considered the gold standard for confirmatory diagnosis of HIT due to its high specificity. However, the downside of SRA is the cost involved, limited availability and a turnaround time of 5-7 days. As such, a heparin confirmatory test (HCT) with excess heparin has been in use since mid 2011 on positive ELISA samples in our laboratory to improve test specificity. This test is more cost and time efficient, with a turnover time of no more than 48 hours. As noted in prior studies, inhibition of a positive ELISA result by 50% or more in the presence of excess heparin is considered confirmatory of heparin-dependent antibodies. Likewise a negative confirmatory test is defined as a decrease of 50% or less in antibody binding in the presence of heparin. Aim a) Correlation of Heparin Confirmatory test (HCT) with strength of HIT ELISA, vis-à-vis optical density (OD) of 0.4 - 0.99 and OD of >/= 1.0. b) Correlation of HCT results with SRA, to see if the latter can be replaced by the heparin confirmatory test. Patients and Methods A retrospective chart review of adult patients hospitalized at our institution with suspected HIT from July 2011 until January 2013 was done. There were 101 such patients. All patients who had a positive HIT ELISA, then had HCT as per our standard lab practice, with an SRA test done for diagnosis/confirmation of HIT, as per standard clinical practice. Historically, the major strength of SRA assay is its specificity. The optical density on HIT ELISA and SRA results were then compared with the Heparin Confirmatory test to establish clinical significance. Results Of the 101 patients tested for HIT ELISA, 49 were positive. HCT and SRA were performed on all 49 samples, 1 out of which was reported as indeterminate. Hence 48 samples were used for primary analysis, comparing HCT to the OD as well as the SRA results. Out of 48 patients, 6 had positive SRA with Heparin inhibition of >50% (sensitivity 6/6 = 100%). Remaining 42 patients had negative SRA, 7 out of which had Heparin inhibition of <50% (specificity 7/42 = 16.6%). All 7 patients with a negative HCT had a negative SRA, making the negative predictive value of the HCT 100%; however positive predictive value was only 14.6% (6/41). There was no correlation between the OD and Heparin Confirmation test. Conclusions Although there is data suggesting that there might be some value to the Heparin Confirmation test, we were unable to show a significant correlation between HCT and OD or between HCT and SRA. The prospect of having a cost effective and rapid assay for laboratory confirmation of HIT will always be a relevant need. We feel that a larger, prospective study should be conducted to definitively assess the relationship between HCT and SRA. Disclosures: No relevant conflicts of interest to declare.


Neurosurgery ◽  
2012 ◽  
Vol 70 (5) ◽  
pp. 1114-1124 ◽  
Author(s):  
Robert T. Wicks ◽  
Gustavo Pradilla ◽  
Shaan M. Raza ◽  
Uri Hadelsberg ◽  
Alexander L. Coon ◽  
...  

Abstract BACKGROUND: Somatosensory evoked potential (SSEP) monitoring is used during intracranial aneurysm surgery to track the effects of anesthesia, surgical manipulation, and temporary clipping. OBJECTIVE: To present the outcomes of 663 consecutive patients (691 cases) treated surgically for intracranial aneurysms who underwent intraoperative SSEP monitoring and to analyze the sensitivity and specificity of significant SSEP changes in predicting postoperative stroke. METHODS: Of 691 surgeries analyzed, 403 (391 anterior circulation, 12 posterior circulation) were unruptured aneurysms and 288 (277 anterior, 11 posterior) were ruptured. Postoperatively, symptomatic patients underwent computed tomography imaging. Positive predictive value, negative predictive value, sensitivity, and specificity were calculated with a Fisher exact test (2-tailed P value). RESULTS: Changes in SSEP occurred in 45 of 691 cases (6.5%): 16 of 403 (4.0%) in unruptured aneurysms and 29 of 288 (10%) in ruptured aneurysms. In unruptured aneurysms, reversible SSEP changes were associated with a 20% stroke rate, but irreversible changes were associated with an 80% stroke rate. In ruptured aneurysms, however, reversible changes were associated with a 12% stroke rate, and irreversible changes were associated with a 42% stroke rate. The overall accuracy of SSEP changes in predicting postoperative stroke was as follows: positive predictive value, 30%; negative predictive value, 94%; sensitivity, 25%; and specificity, 95%. CONCLUSION: Intraoperative SSEP changes are more reliable in unruptured aneurysm cases than in ruptured cases. Whereas irreversible changes in unruptured cases were associated with an 80% stroke rate, such changes in ruptured cases did not have any adverse ischemic sequelae in 58% of patients. This information is helpful during the intraoperative assessment of reported SSEP changes.


2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Anselm Bräuer ◽  
Sebastian Gassner ◽  
Jochim Koch ◽  
Daniel Heise ◽  
Michael Quintel

Background. Perioperative hypothermia is still a major problem. Therefore, it would be useful to predict which warming method would prevent perioperative hypothermia in a particular patient. Methods. The simulation software “ThermoSim Vers. 5.07” was validated using the data of two prospective, randomized, and controlled studies. The diagnostic effectiveness was assessed by calculating sensitivity and specificity, positive predictive value (PPV), and negative predictive value (NPV) in the detection of perioperative hypothermia. Results. Sensitivity of the software was 100% (Study 1) and 94% (Study 2), specificity was 67% (Study 1) and 38% (Study 2), PPV was 60% (Study 1) and 50% (Study 2), and NPV was 100% (Study 1) and 90% (Study 2). Conclusions. The software is helpful in predicting which warming method is necessary to prevent perioperative hypothermia. Thermal treatment based on the prediction of the software will lead to some overtreatment, but will prevent perioperative hypothermia reliably.


2021 ◽  
Vol 5 (4) ◽  
pp. 1067-1073
Author(s):  
Heriyadi Manan ◽  
Edo Rezaldy Edward

Background.  Endometriosis is a benign disorder defined by the presence of endometrial glands and stroma outside the uterus. Endometriosis occurs in 10-15% of women during their reproductive years. Angiogenesis and the inflammatory response are important factors in the development of endometriosis. The formation of a new blood supply is a crucial step in the formation of endometrial lesions. Angiogenesis is induced by a growth factor peptide, namely vascular endothelial growth factor A (VEGF-A). VEGF-A is known as a vascular permeability factor that plays an important role in the pathological angiogenesis process and is a more specific and prominent angiogenesis factor among the VEGF family. The purpose of this study was to determine the sensitivity and specificity of examination    VEGF-A   of menstrual blood in diagnosing endometriosis compared to laparoscopy. Methods. This diagnostic test research has been carried out at the gynecology polyclinic, especially the division of Fertility, Endocrinology and Reproduction, Faculty of Medicine, Sriwijaya University- Dr. Central General Hospital. Mohammad Hoesin from August to November 2018, there were 45 patients who met the inclusion criteria. VEGF-A examination in instrumental blood based on ELISA examination. Data analysis to measure sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy using Medcalc statistics. Results. From the results of this study, it is known that the majority of the study samples were aged 31.69 years (24-38 years) 75.6%, body mass index (BMI) 51.1% with normal BMI, experienced infertility by 82.2% of the sample, most of the samples did not smoke (95.6%) and most experienced mild pain 55.6% using the VAS pain scale. From this study, it is known that 84.4% or 38 of the study samples had endometriosis with a cut off point value of VEGF-A > 347 pg/mL. From the results of this study, it is known that the sensitivity of VEGF-A in diagnosing endometriosis is 84.2%, specificity is 85.7%, positive predictive value is 97%, negative predictive value is 50% and accuracy is 84%. Conclusion. VEGF-A menstrual blood can be used as a diagnostic tool for endometriosis.


Author(s):  
Himanshu Chhagan Bayad ◽  
Sanjeev Bhagat ◽  
Dimple Sahni ◽  
Navneet Kaur ◽  
Ravinder Singh ◽  
...  

<p class="abstract"><strong>Background:</strong> Oral carcinoma is among the most prevalent malignancies of head and neck region and is often diagnosed in the advanced stage with significant morbidity and treatment cost. Thus, there is a need for early detection of oral premalignant and malignant lesions. Toluidine blue staining can be used for early detection of these lesions.</p><p class="abstract"><strong>Methods:</strong> The study included 50 patients with clinically suspicious oral premalignant and malignant lesions. These lesions were subjected to toluidine blue staining and biopsy. Diagnoses were confirmed by histopathological examination.  </p><p class="abstract"><strong>Results:</strong> Sensitivity and specificity of toluidine blue for oral premalignant lesions was 92.30% and 80% respectively with the positive predictive value of 92.30%, negative predictive value of 80% and accuracy of 88.88%. Sensitivity and specificity of toluidine blue for oral malignant lesions was 96.30% and 80% respectively with the positive predictive value of 96.30%, negative predictive value of 80% and accuracy of 93.75%.</p><p class="abstract"><strong>Conclusions:</strong> The simplicity of toluidine blue staining and its accuracy suggest that it can be a useful adjunctive tool to diagnosis of oral lesions. Results should be carefully evaluated and correlated with clinical findings and histopathological diagnosis.</p>


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