Cytomegalovirus Has No Impact on Immune Thrombocytopenia Bleeding Scale or Prognostic Outcomes in Egyptian Pediatric Immune Thrombocytopenia

Background Cytomegalovirus (CMV) has been implicated as one of the etiological factors of immune thrombocytopenia (ITP) in many reports. Objectives We aimed to estimate the frequency of CMV positivity among childhood ITP patients, and to assess its impact on severity of bleeding, chronicity of the disease, and response to therapy. Methods A cross-sectional study was performed including 40 Egyptian pediatric patients with ITP. CMV infection was detected by serological testing and polymerase chain reaction (PCR). Clinical assessment for bleeding severity using ITP bleeding scale (IBLS) and initial response to therapy were included in the study. Results The prevalence of CMV DNAemia among the ITP patients was 72.5%. The virus DNAemia was higher among newly diagnosed ITP cases compared with chronic ones (85 and 60% respectively, p = 0.07). There were no significant differences in age, gender, bleeding severity, or initial clinical presentation in patients who were CMV-PCR positive or negative (p > 0.05). Refractory cases were found in 17.2% of CMV-positive cases compared with 36.4% in CMV-negative ones (p = 0.29). Specificity and sensitivity of serological assay in comparison to PCR were 72.4% and 20.69%, respectively, with a negative predictive value of 25.8%, and a positive predictive value of 66.7%. Conclusion Cytomegalovirus appears to have a high frequency among both newly diagnosed and chronic ITP patients in Egypt. CMV serological assay for IgM was not a good indicator of the presence of viral infection. CMV DNAemia seems to have no significant effect on severity of bleeding, clinical presentation, or outcomes of childhood ITP.

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Prediction of histological stage based on cystoscopic appearances of newly diagnosed bladder tumours

Annals of The Royal College of Surgeons of England ◽

10.1308/rcsann.2016.0246 ◽

2016 ◽

Vol 98 (8) ◽

pp. 547-551 ◽

Cited By ~ 5

Author(s):

VA During ◽

GM Sole ◽

AK Jha ◽

JA Anderson ◽

RT Bryan

Keyword(s):

Bladder Cancer ◽

Predictive Value ◽

Bladder Tumour ◽

Visual Assessment ◽

Invasive Bladder Cancer ◽

Newly Diagnosed ◽

Muscle Invasive Bladder Cancer ◽

Cross Sectional ◽

Radiological Staging ◽

Muscle Invasive

INTRODUCTION In the 75–80% of urothelial bladder cancers (UBC) presenting as non-muscle invasive bladder cancer (NMIBC), transurethral resection of bladder tumour (TURBT) is the key treatment and staging procedure. In the 20–25% of patients with muscle invasive bladder cancer (MIBC), further cross-sectional imaging is required to complete the staging process before considering radical treatment. Given the adverse effects of ionising radiation, clinicians identify patients believed to have MIBC, and so requiring further imaging pre-TURBT, at the tumour histology/stage based on the tumour’s visual characteristics. There is minimal evidence describing the accuracy of such predictions in newly-diagnosed patients. METHODS Over a 6-year period, a database of patients undergoing resection of newly-diagnosed bladder lesions in a single UK centre was prospectively established. Predictions based on histology were simultaneously recorded, and the accuracy of these predictions of histology/stage subsequently assessed. RESULTS One hundred and twenty two (73.1%) patients with histologically confirmed NMIBC had predictions recorded versus 45 (26.9%) patients with MIBC. Visual assessment predictions of MIBC had a sensitivity of 88.9% (95% confidence interval [CI] 76.5%–95.2%) and a specificity of 91.0% (95% CI 84.6%–94.9%), giving a positive predictive value of 78.4% (95% CI 65.4%–87.5%) and a negative predictive value of 95.7% (95% CI 90.3%–98.1%). CONCLUSIONS We find that visual assessment is accurate in predicting the presence of MIBC. This supports the practice of stratifying patients at the time of initial cystoscopy for those requiring further radiological staging pre-TURBT.

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Role of Covid Antigen in the Diagnosis of Covid Positive in Obstetric Patients

10.53350/pjmhs2115103356 ◽

2021 ◽

Vol 15 (10) ◽

pp. 3356-3358

Author(s):

Ambreen Fatima ◽

Nidda Yaseen ◽

Amna Fareed ◽

Kashif Ali Samin ◽

Shumaela Kanwal ◽

...

Keyword(s):

Nucleic Acid ◽

Early Detection ◽

Negative Predictive Value ◽

Predictive Value ◽

False Negative ◽

Nucleic Acid Amplification ◽

Antigen Test ◽

Rt Pcr ◽

Cross Sectional ◽

Specificity And Sensitivity

Background and Aim: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid emergence postured significant challenges on the health system in recent years. The early detection of cases is thought to be critical in preventing this pandemic by coronavirus disease (COVID-19), especially important in the obstetrical population due to theirs numerous interactions with another parturient when hospitalized for delivery. Therefore, the present study aimed to assess the COVID antigen test performance in COVID-positive obstetrics patients. Materials and Methods: This cross-sectional study was conducted on 1296 Covid-19 asymptomatic women admitted to the Obstetrics and Gynaecology Department of Muhammad Teaching Hospital & Medical College, Peshawar and Fauji Foundation Hospital, Rawalpindi for the duration of six months from February 2021 to July 2021. Antigen-based test rapid diagnostic test (RDT) was used for screening out COVID-19 positive obstetrics patients or women through nasopharyngeal swabs. Women with negative rapid antigen test results were confirmed with RT-polymers chain reaction test of nucleic acid amplification tests (NAAT). Ethical approval and informed consent were taken from the hospital ethical committee and each individual respectively. All the known positive COVID-19 patients during admission were excluded. SPSS version 24 was used for data analysis. Results: The overall prevalence of rapid antigen-positive tested patients was 13.2% (171/1296). The prevalence of positive tested women through rapid antigen test, Nucleic Acid Amplification Test (NAAT), and RT-PCR were 27 (2.1%), 51 (3.9%), and 93 (7.2%) respectively. Of the total 1296 rapid antigen tests, 27 were positive, and the false-negative confirmed positive by NAAT was 144.Thus the sensitivity of the rapid antigen test was 15.8% and the negative predictive value was 93.7%. Of the total 298 Nucleic Acid Amplification Tested had sensitivity and negative predictive value of 89.6% and 99.06% respectively. RT-PCR was carried out on 972 patients, positive diagnosed cases were 36 while 15 were initially negative and were positive with the test was repeated. The sensitivity and negative predictive value was 71.45% and 95.8% respectively. Conclusion: Our study found that Ag-RDT plays a significant role in SARS-CoV-2 early detection in infected individuals, with high specificity and sensitivity to disease infectious stage, whether symptomatic or asymptomatic, and can be used as a decision supported tool. Early detection of COVID-19 status in women admitted for delivery could benefit neonatal protection care. Keywords: Covid-19; Rapid antigen test; RT-PCR test

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Hypovitaminosis D Influences the Clinical Presentation of Immune Thrombocytopenia in Children with Newly Diagnosed Disease

Journal of Clinical Medicine ◽

10.3390/jcm8111861 ◽

2019 ◽

Vol 8 (11) ◽

pp. 1861

Author(s):

Petrovic ◽

Benzon ◽

Batinic ◽

Culic ◽

Roganovic ◽

...

Keyword(s):

Immune Thrombocytopenia ◽

Clinical Presentation ◽

Coastal Region ◽

Autoimmune Disorder ◽

Hypovitaminosis D ◽

Severe Bleeding ◽

Newly Diagnosed ◽

Randomized Controlled Studies ◽

Bleeding Score ◽

D Values

Immune thrombocytopenia (ITP) is an acquired autoimmune disorder characterized by isolated thrombocytopenia defined as platelet count in peripheral blood <100 × 109/L. Hypovitaminosis D is very common in children with autoimmune diseases. To analyze whether hypovitaminosis D is associated with the clinical presentation of ITP in children, medical records of 45 pediatric patients with newly diagnosed immune thrombocytopenia in the coastal region of Croatia were evaluated. The severity of bleeding was assessed using two bleeding scores. Children with lower 25-hydroxyvitamin D (25(OH)D) values had higher values of the skin-mucosa-organ-gradation (SMOG) bleeding score and respectively more severe bleeding on diagnosis of ITP. With further analysis of the main domains of that score, we found that patients with a lower 25(OH)D value had more severe bleeding in the skin and organs. When 25(OH)D and ITP Bleeding Scale (IBLS) score were analyzed, a negative correlation was found, but it was not significant. Our findings suggest that hypovitaminosis D influences the severity of the clinical presentation of ITP in children on initial diagnosis of the disease. Therefore, therapy with 25(OH)D could be a new potential option for treatment of ITP. To investigate the connection between 25(OH)D and the incidence and severity of ITP, further studies, especially randomized controlled studies, are needed.

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DIAGNOSTIC ACCURACY OF BARIUM ENEMA FINDINGS IN HIRSCHSPRUNG'S DISEASE

ABCD Arquivos Brasileiros de Cirurgia Digestiva (São Paulo) ◽

10.1590/0102-6720201600030007 ◽

2016 ◽

Vol 29 (3) ◽

pp. 155-158 ◽

Cited By ~ 6

Author(s):

Mehran PEYVASTEH ◽

Shahnam ASKARPOUR ◽

Nasrollah OSTADIAN ◽

Mohammad-Reza MOGHIMI ◽

Hazhir JAVAHERIZADEH

Keyword(s):

Barium Enema ◽

Predictive Value ◽

Hirschsprung's Disease ◽

Hirschsprung’S Disease ◽

Transitional Zone ◽

Dentate Line ◽

Contrast Enema ◽

Cross Sectional ◽

Specificity And Sensitivity ◽

Sensitivity Specificity

ABSTRACT Background: Hirschsprung's disease is the most common cause of pediatric intestinal obstruction. Contrast enema is used for evaluation of the patients with its diagnosis. Aim: To evaluate sensitivity, specificity, positive predictive value, and negative predictive value of radiologic findings for diagnosis of Hirschsprung in patients underwent barium enema. Methods: This cross sectional study was carried out in Imam Khomeini Hospital for one year starting from 2012, April. Sixty patients were enrolled. Inclusion criteria were: neonates with failure to pass meconium, abdominal distention, and refractory constipation who failed to respond with medical treatment. Transitional zone, delay in barium evacuation after 24 h, rectosigmoid index (maximum with of the rectum divided by maximum with of the sigmoid; abnormal if <1), and irregularity of mucosa (jejunization) were evaluated in barium enema. Biopsy was obtained at three locations apart above dentate line. PPV, NPV, specificity , and sensitivity was calculated for each finding. Results: Mean age of the cases with Hirschsprung's disease and without was 17.90±18.29 months and 17.8±18.34 months respectively (p=0.983). It was confirmed in 30 (M=20, F=10) of cases. Failure to pass meconium was found in 21(70%) cases. Sensitivity, specificity, PPV, and NPV were 90%, 80%, 81.8% and 88.8% respectively for transitional zone in barium enema. Sensitivity, specificity, PPV, and NPV were 76.7%, 83.3%, 78.1% and 82.1% respectively for rectosigmoid index .Sensitivity, specificity, PPV, and NPV were 46.7%, 100%, 100% and 65.2% respectively for irregular contraction detected in barium enema. Sensitivity, specificity, PPV, and NPV were 23.3%, 100%, 100% and 56.6% respectively for mucosal irregularity in barium enema. Conclusion: The most sensitive finding was transitional zone. The most specific findings were irregular contraction, mucosal irregularity, and followed by cobblestone appearance.

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Incidence of Primary Immune Thrombocytopenia (ITP) in Adults in One Region of Russia

Blood ◽

10.1182/blood.v128.22.4941.4941 ◽

2016 ◽

Vol 128 (22) ◽

pp. 4941-4941

Author(s):

Anait L. Melikyan ◽

Elena I Pustovaya ◽

Elena M. Volodicheva ◽

Tamara I Kolosheinova ◽

Marina V Kalinina ◽

...

Keyword(s):

Incidence Rate ◽

Immune Thrombocytopenic Purpura ◽

Immune Thrombocytopenia ◽

Response To Therapy ◽

Research Database ◽

Newly Diagnosed ◽

Thrombocytopenic Purpura ◽

Target Region ◽

Primary Immune Thrombocytopenia ◽

Epidemiological Characteristics

Abstract Introduction. Primary immune thrombocytopenia is a rare disease1. The incidence of ITP is not well estimated in Russia and worldwide. In adults it varies from 1,6 to 3,9/100 000 person-years2-3. The gender and age-associated results are discussed and differ in several investigations4-6. Study objectives: evaluation of the incidence of primary immune thrombocytopenia in adults in one region of Russia Patients and methods. The data source is the Registry of the patients with primary ITP in Russia. 272 adult patients: 77 males (28%) and 195 females (72%), age from 16 to 89 years (median 44 years) with ITP (ICD-10 code D69.3), newly diagnosed cases during the period from 12 Jan 2014 to 24 May 2016. Results. 221 (81%) cases were newly diagnosed in 12 regions of Russia in which registration was performed most actively - more than 5 cases for the duration of the study. But only one region was selected for the first evaluation of epidemiological characteristics because of the number of reasons. There is one hematological central clinic in this region in which diagnosis of ITP can be verified and patients with ITP are treated and monitored most properly. The early started and fully performed registration process can be regarded as covered most part of region population in this target region. 86 cases (27 male, 59 female) were registered in the target region. The gender-age distribution was following: male: age <41 = 10 (37%), age <41-60 = 7 (26%), age >60 = 10 (37%); female: age <29 = 10 (49%), age <41-60 = 15 (25%), age >60 = 15 (25%). The estimated incidence rate in the target region is shown in table 1. The estimated incidence rates in gender-age strata in the target region are demonstrated in table 2. Conclusion. Overall ITP incidence in one region of Russia is 3.20/100 000 person-years. It is compatible to the incidence in other European countries. Our data demonstrate the rise of incidence rate in males with age and its decrease with age in female population. Literature. 1) Rodeghiero F., Stasi R., Gernsheimer T., Michel M., Provan D., Arnold D.M., et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from international working group. Blood. 2009; 113(11): 2386--93. doi: 10.1182/blood-2008-07-162503. 2) Terrell DR, Beebe LA, Vesely SK, Neas BR, Segal JB, George JN. The incidence of immune thrombocytopenic purpura in children and adults: A critical review of published reports. Am J Hematol. 2010; 85(3): 174-180. 3) Moulis G, Palmaro A, Montastruc J-L, Godeau B, Lapeyre-Mestre M, Sailler L. Epidemiology of incident immune thrombocytopenia: a natiowide population-based study in France. Blood. 2014; 124(22): 3308-3315. 4) Segal JB, Powe NR. Prevalence of immune thrombocytopenia: analyses of administrative data. J Thromb Haemost 2006; 4: 2377-83 5) Schoonen WM, Kucera G, Coelson J, et al. Epidemiology of immune thrombocytopenic purpura in the General Practise Research Database. Br J Haematol 2009; 145(2): 235-244. 6) Lisukov I.A., Maschan A.A., Shamardina A.V., Chagorova T.V., Davydkin I.L., Sycheva T.M., et al. Immune thrombocytopenia: clinical manifestations and response to therapy. Intermediate analysis of data of the Russian register of patients with primary immune thrombocytopenia and review of literature. Oncogematologiya. 2013; 2: 61--9]. Disclosures No relevant conflicts of interest to declare.

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Evaluating Bleeding Severity in Children with newly Diagnosed Immune Thrombocytopenia: A Pilot Study

Klinische Pädiatrie ◽

10.1055/s-0030-1267150 ◽

2010 ◽

Vol 222 (06) ◽

pp. 374-377 ◽

Cited By ~ 2

Author(s):

J. Pansy ◽

M. Minkov ◽

R. Dengg ◽

F. Quehenberger ◽

H. Lackner ◽

...

Keyword(s):

Pilot Study ◽

Immune Thrombocytopenia ◽

Newly Diagnosed ◽

Bleeding Severity

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Antiplatelet Glycoprotein Antibodies Profile in Adult Patients with Primary Immune Thrombocytopenia and the Comparison with Regards to the Treatment Response to Corticosteroids

Blood ◽

10.1182/blood.v126.23.4653.4653 ◽

2015 ◽

Vol 126 (23) ◽

pp. 4653-4653

Author(s):

Tubagus Djumhana Atmakusuma ◽

Lugyanti Sukrisman ◽

Fransiska Hardi

Keyword(s):

Immune Thrombocytopenia ◽

Response Rates ◽

Complete Response ◽

Cross Sectional Study ◽

Adult Patients ◽

Published Data ◽

Newly Diagnosed ◽

Cross Sectional ◽

Chronic Itp ◽

The Mean

Abstract Background: Platelet destruction in immune thrombocytopenia (ITP) is mediated by autoantibodies against platelet antigens. Anti-GPIIb/IIIa and anti-GPIb/IX antibodies are two major antibodies spesific for platelets and megakaryocytes. The diversity of clinical characteristics and therapeutic responses have been thought to be influenced by heterogeneity of spesific glycoprotein complexes. However, there has been no published data regarding either antiplatelet antibodies profile or response rates to corticosteroid, in adult patients with primary ITP. Objectives: To determine antiplatelet glycoprotein antibodies profile in adult patients with primary ITP and to compare the response rate to corticosteroid referring to the profile. Methods: This study is a cross sectional study in adult patients with primary ITP who visited Hematology Clinics in Dr Cipto Mangunkusumo Hospital, Jakarta, Indonesia, in a period of March to October 2013. The tests to determine the auto antibodies against the platelet GPIIb/IIIa and GPIb/IX surface antigens were performed by a direct MAIPA technique. Results: A total of 40 patients who were diagnosed as primary ITP have been enrolled into the study. The subjects of the study were divided in two groups, 10 subjects with newly diagnosed ITP, and 30 subjects with persistent or chronic ITP. Most of the subjects were female (82.5 %) with the median age was 24,5 (17-55) years old.. Seventy (??) subjects had ITP Bleeding Score (IBLS) 2.. In a persistent/chronic ITP group (n= 30), the proportion of anti-GPIIb/IIIa was 20 / 30 (66,67 %) with the median optical density (OD) was 0,461 (0,093-2,116) and the proportion of anti-GPIb/IX was 25/30 (83.33%) with the median OD was 0,507 (0,190-1,924). Meanwhile, in a newly diagnosed ITP group (n=10) the proportion of anti-GPIIb/IIIa was 7/10 (70%) with the mean OD was 0,802 ± 0,71 and the proportion of anti-GPIb/IX was 8/10 (80%) with the mean OD 0,82 ± 0,57. The response rates to corticosteroid were as follows: 42.5 % of the subjects achieved complete response, 45 % achieved response, and 12.5 % achieved no response. Comparison between the subjects with and without anti-GPIIb/IIIa and anti-GPIb/IX antibodies showed similarity response rates to prednisone. Conclusion: Sincemost of patients with primary ITP had anti GPIIb/IIIa and anti GPIb/IX antibodies, those antibodies may support a diagnosis of primary ITP. Since no differences in terms of the response rates to corticosteroid between subjects with and without anti-GPIIb/IIIa and anti-GPIb/IX antibodies, those antibodies can not be used as a predictor of the treatment Disclosures Sukrisman: Division of Hematology Medical Oncology: Other: Colleague.

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Accuracy of the Corvis Biomechanical Index in Keratoconus Screening

Pakistan Journal of Ophthalmology ◽

10.36351/pjo.v36i3.1072 ◽

2020 ◽

Vol 36 (3) ◽

Author(s):

Fazle Hanan ◽

Zulfiqar Ali ◽

Muhammad Naeem

Keyword(s):

Predictive Value ◽

Sampling Technique ◽

Cross Sectional Study ◽

Clinical Feature ◽

Control Group ◽

Cross Sectional ◽

Specificity And Sensitivity ◽

Cross Linkage ◽

The Mean ◽

Normal Controls

Purpose: To evaluate the accuracy of the Corvis Biomechanical Index (CBI) in screening of patients with Keratoconus. Study Design: Cross sectional study. Place and Duration of Study: Amanat Eye Hospital Peshawar from July 2018 to June 2019. Material and Methods: One thousand eyes were included in this study. Patients who came for keratorefractive laser procedure or collagen cross linkage were included in the study by convenient sampling technique. Six hundred and eleven patients had early Keratoconus and 389 were normal controls. Control group included those individuals who had visual acuity of 6/6 with no clinical feature of Keratoconus and normal TBI. All individuals included in the study underwent a thorough ocular examination, CBI and TBI tests. SPSS version 23 was used for statistical analysis of collected data. Results: The mean CBI value was 0.3186 ± 0.407 standard deviation (SD), the standard error (SE) of the mean was 0.0129 with a 95% confidence interval (CI) of 0.293 to 0.343. The minimum CBI value was 0.00 and the maximum value was 1.00. The mean Tomographic Biomechanical Index (TBI) value was 0.465 ± 0.392 SD, SE was 0.124 with a 95% CI of 0.222 to 0.708. The range of TBI values was 0.00 to 1.00. For CBI, sensitivity was 58.2%, specificity was 100%, positive predictive value was 100%, and negative predictive value was 61.2%. Conclusion: Although CBI is accurate in terms of specificity and sensitivity, the result should be interpreted in combination with clinical data and other topographic and tomographic parameters.

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Clinical and hematological features of childhood immune thrombocytopenia at Pediatric Center of Hue Central Hospital

Journal of Clinical Medicine- Hue Central Hospital ◽

10.38103/jcmhch.2021.72.10 ◽

2021 ◽

Keyword(s):

Immune Thrombocytopenia ◽

Cross Sectional Study ◽

Severe Thrombocytopenia ◽

Newly Diagnosed ◽

Central Hospital ◽

Cross Sectional ◽

Female Ratio ◽

Chronic Itp ◽

History Of ◽

Pediatric Center

Background: Immune thrombocytopenia (ITP) is the most common of the hemorrhagic diseases caused by thrombocytopenia in children. It usually occurs between the ages of 5 and 7 years old and at both sexes. It is difficult to predict ITP basing on bleeding because some severe thrombocytopenia cases have slight purpura or ecchymoses. This study aims to describe the clinical and hematological features of childhood immune thrombocytopenia Methods: This was a cross - sectional study. Patients were stratified according to age (0 to 15 years) and diagnosed ITP at the Pediatric Center of Hue central Hospital. Results: From May 2020 to March 2021, we identified 42 children diagnosed with idiopathic thrombocytopenia. Newly diagnosed ITP was the most common (66.7%) followed by chronic ITP (26.2%) and persistent ITP (7.1%). There was a slight predominance of boys to girls with the male - to - female ratio was 2:1. However, this ratio was dependent on ITP phases. The highest prevalence of immune thrombocytopenia was found under 6 years old. Children in this study usually had a history of preceding infection or vaccination. Natural hemorrhage was 83.3% (skin 95.2%). The most common type of cutaneous bleeding was petechiae (83.3%). Mild to moderate hemorrhages were dominant. Newly diagnosed ITP had less severity of hemorrhage than persistent and chronic ITP. Most children did not have a fever, hepatomegaly, splenomegaly, and lymphadenopathy. The majority of children seem to have severe thrombopenia (66.7%), but the number of platelets was not related to the severity of bleeding. Mean platelet volume was normal. Conclusions: Newly diagnosed ITP was the most common. There was a little clinical and hematological features difference between the ITP phases.

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Detection of Platelet Autoantibodies Revisited to Identify Immune Thrombocytopenia

Blood ◽

10.1182/blood.v126.23.1142.1142 ◽

2015 ◽

Vol 126 (23) ◽

pp. 1142-1142 ◽

Cited By ~ 3

Author(s):

Leendert Porcelijn ◽

Elly Huiskes ◽

Gonda Oldert ◽

Rob Fijnheer ◽

Martin R. Schipperus ◽

...

Keyword(s):

Sensitivity And Specificity ◽

Clinical Evaluation ◽

Predictive Value ◽

Immune Thrombocytopenia ◽

Response To Therapy ◽

Platelet Glycoprotein ◽

Control Group ◽

Control Groups ◽

Platelet Counts ◽

Platelet Autoantibodies

Abstract Introduction: Immune Thrombocytopenia (ITP) is still diagnosed by exclusion of many other causes for thrombocytopenia. In order to prevent misdiagnosis, an ITP-specific diagnostic test would be very helpful. In addition, characterization of glycoprotein specificity of platelet autoantibodies may explain (the severity of) bleeding symptoms and response to therapy. In this regard, we optimized the cut-off value of the direct monoclonal antibody immobilization of platelet antigens (MAIPA) assay for detection of platelet glycoprotein directed autoantibodies and re-evaluated its sensitivity and specificity for the diagnosis of ITP. Materials and Methods: The MAIPA was performed as part of our routine protocol, described by Kiefel et al. (1985). For the determination of a new cut-off value, and to calculate the sensitivity and specificity, blood samples were tested from 462 healthy blood donors and 43 non-immune-mediated thrombocytopenic patients, suffering from either hematological malignancies or aplastic anemia (n=20), hepato-splenomegalic pooling (n=3), drug-induced thrombocytopenias (n=4), viral infections (n=6), pregnancy related thrombocytopenia (n=7), pseudothrombocytopenias (n=2) and microangiopathy (n=1) and from 60 known ITP patients. We then have tested 120 prospectively collected samples from thrombocytopenic patients, sent for diagnostic tests to our laboratory, and categorized these samples based on subsequently obtained clinical evaluation into 'most likely ITP' (n=64) or 'most likely non-ITP' (n=56). Results: The calculated direct MAIPA sensitivity and specificity, using a cut-off value of E=0.130, in the ITP and non-ITP control groups (n=103) were 85% (95% CI, 73-93%) and 100% (95% CI, 92-100%), respectively (see Figure). The platelet auto-antibodies in the ITP control group (n=60) were directed against glycoprotein (GP)IIb/IIIa (66.7%), GPIb/IX (60%), GPV (51.7%), GPIa/IIa (40.6%) and/or GPIV (26.9%). The calculated sensitivity and specificity for detection of platelet auto-antibodies in the prospective diagnosed ITP and non-ITP patient control groups (n=120) were 75% (95% CI, 63-85%) and 96% (95% CI, 88-100%), respectively (see Figure). For this group of patients, the direct MAIPA showed, for diagnosis of ITP, a negative predictive value (NPV) of 77% (95% CI, 66-86%) and a positive predictive value (PPV) of 96% (95% CI, 86-100%). Furthermore, in 23 ITP patients the sequential sampling in a rituximab-treatment protocol showed platelet counts that were significantly and inversely correlated with the direct-MAIPA extinctions (p=0.006). In this respect, we excluded that higher platelet counts impaired the detection of platelet autoantibodies - e.g. by diluting them over an higher platelet mass-since autoantibodies were successfully detected in samples from ITP patients (n=4) with, as a result of splenectomy, platelet counts above 100 x 109/L and in untreated ITP patients with platelet counts between 75 and 100 x 109/L. These findings may implicate that response to rituximab as reflected by a rise in platelet counts is dependent on antibody presence, but the mechanism of effective lowering of platelet autoantibody levels by rituximab is still unclear. In conclusion, the revisited direct MAIPA showed to be a valuable technique for the detection of platelet autoantibodies both at diagnosis and during treatment and can possibly become a guide for optimizing therapy towards a more personalized treatment of ITP. Direct MAIPA O.D. above 0.13 is considered positive. Control samples: historically well characterized ITP patients. Prospective study: requests for serological ITP diagnostics, after final clinical evaluation classified as ITP or non-ITP. Figure 1. Figure 1. Disclosures Schipperus: Novartis: Consultancy.

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