Variable Performance of Lupus Anticoagulant Testing: The Australasian/Asia-Pacific Experience.

Lupus anticoagulant (LA) is one of three tests identified as laboratory criteria for definite antiphospholipid syndrome (APS). The other two tests are anticardiolipin antibody (aCL) and anti-β2-glycoprotein I (aβ2GPI) antibody. The presence of LA is assessed using clot-based tests, while the presence of aCL and aβ2GPI is assessed by immunological assays.

Evaluating Performance of Contemporary and Historical von Willebrand Factor (VWF) Assays in the Laboratory Identification of von Willebrand Disease (VWD): The Australasian Experience.

von Willebrand disease (VWD) is a common bleeding disorder that arises from deficiency and/or defects of von Willebrand factor (VWF). Appropriate diagnosis of VWD, including differential identification of qualitative (types 2A, 2B, 2M, 2N VWD) quantitative (types 1 and 3 VWD) defects remains problematic but has important management implications, given differential therapy. Complete assessment for VWD in a patient with a bleeding history requires comprehensive test panels, including VWF activity and antigen.

A survey of Australian haematology reference intervals.

This study was designed to create a snapshot of Australian haematology reference intervals (RIs) in use, in particular red cell parameters. We present an analysis of survey results conducted across Australian laboratories between November 2012 and January 2013.All Australian laboratories enrolled in the Royal College of Pathologists of Australasia Quality Assurance Program (RCPA QAP) were invited to participate in the December 2012 Survey Monkey survey, with a response from 85 laboratories (17%) received.

Evaluating laboratory approaches to the identification of lupus anticoagulants: a diagnostic challenge from the RCPA Haematology QAP.

Background: Laboratory identification of lupus anticoagulants (LA), an important component of the clinical diagnosis of the autoimmune disorder antiphospholipid syndrome (APS), is challenged by the heterogeneity of tests available, the diagnostic and laboratory approach undertaken, and the heterogeneity of the autoantibodies present.

Aim: : To assess the laboratory approach for investigation of LA, as well as the utility of various tests and test approaches, given a difficult clinical scenario in which LA might or might not be present.

Methods: Ninety-three participants in the Royal College of Pathologists of Australasia (RCPA) Haematology Quality Assurance Program (QAP) were sent 4  mL of a complex but strongly positive LA sample blinded to the nature of the abnormality.

Serum vitamin A and E analysis: comparison of methods between laboratories enrolled in an external quality assurance programme.

Aim: To survey laboratories enrolled in the Royal College of Pathologists of Australasia (RCPA) Chemical Pathology Quality Assurance Programme (QAP) for vitamin A and E testing to determine differences between methods of analysis.

Methods: A detailed questionnaire covering the major aspects of serum vitamin A and E analysis was sent to all participating laboratories in 2007.

Results: Thirteen out of the 22 laboratories completed the questionnaire.

Methodology and outcomes of platelet aggregation testing in Australia, New Zealand and the Asia-Pacific region: results of a survey from the Royal College of Pathologists of Australasia Haematology Quality Assurance Program.

Platelet aggregometry is widely used to investigate platelet function but its performance is poorly standardized between laboratories. The aim of this work was to document the platelet aggregation methods used in specialist laboratories enrolled in the Haematology Quality Assurance Program of the Royal College of Pathologists of Australasia. A questionnaire requesting many details of methodology was distributed and from the responses, we determined a consensus view.

Mis-identification of factor inhibitors by diagnostic haemostasis laboratories: recognition of pitfalls and elucidation of strategies. A follow up to a large multicentre evaluation.

Aims: We previously reported the ability of diagnostic haemostasis facilities to identify coagulation factor abnormalities and inhibitors, through a large multi-centre study conducted on behalf of the Royal College of Pathologists of Australasia (RCPA) Quality Assurance Program (QAP). In the current report, additional data evaluation aims to (1) help identify the reasons behind the failures in inhibitor identification, (2) highlight the pitfalls in inhibitor testing, and (3) help elucidate some strategies for overcoming these problems and to assist in better identification and characterisation of inhibitors.

Methods: Forty-two laboratories blind tested a set of eight samples for the presence or absence of inhibitors.

Emerging technologies and quality assurance in hemostasis: a review of findings from the Royal College of Pathologists of Australasia Quality Assurance Program.

Regular multilaboratory surveys of laboratories by the Royal College of Pathologists of Australasia Quality Assurance Program (QAP) have been conducted to assess proficiency in tests of hemostasis for the last 40 years. This article focuses primarily on specialized assays of hemostasis, for which surveys have been conducted for some 10 years. For von Willebrand disease (vWD) evaluations, a total of 47 plasma samples have been dispatched to survey participants, including representative samples from normal individuals plus all of the major vWD subtypes (i.

Reporting of estimated glomerular filtration rate (eGFR) in New Zealand--what are the clinical laboratories doing?

Introduction: Recent guidelines recommend automatic reporting of estimated glomerular filtration rate (eGFR) using the abbreviated Modification of Diet in Renal Disease (MDRD) equation with every request for plasma creatinine in patients aged >18 years. We evaluated the uptake of this recommendation in New Zealand at 6 months after the time that these recommendations were made.

Method: A questionnaire was sent to all laboratories participating in the Royal Australasian College of Pathologists' General Chemistry Quality Assurance Program (RCPA QAP), asking whether laboratories routinely report eGFR, to what extent the specific recommendations have been followed and what feedback there had been from clinicians.

An international survey of current practice in the laboratory assessment of anticoagulant therapy with heparin.

Aims: We conducted a survey of laboratory practice for assessment of heparin anticoagulant therapy by participants of the Royal College of Pathologists of Australasia Quality Assurance Program (RCPA QAP).

Methods: A questionnaire was sent to 646 laboratories enrolled in the Haematology component of the QAP, requesting details of tests used for monitoring heparin therapy.

Results: Seventy laboratories (10.

How useful is the monitoring of (low molecular weight) heparin therapy by anti-Xa assay? A laboratory perspective.

We have conducted a series of laboratory-based surveys to assess variability in assay results utilized to monitor heparin anticoagulant therapy. These surveys involved laboratories participating in the Haematology component of the Royal College of Pathologists of Australasia Quality Assurance Program (RCPA QAP). Thirty five of 646 laboratories that were sent a preliminary questionnaire indicated that they performed anti-Xa assays and these laboratories were sent a panel of four plasma samples.

A multilaboratory peer assessment quality assurance program-based evaluation of anticardiolipin antibody, and beta2-glycoprotein I antibody testing.

We evaluated the performance of anticardiolipin (aCL) and beta2-glycoprotein I (beta2-GPI) antibody assays through a large external quality assurance program. Data from the 2002 cycle of the Royal College of Pathologists of Australasia Quality Assurance Program (RCPA QAP) were analyzed for variation in reported numerical values and semiquantitative results or interpretations according to method type or group and in conjunction with available clinical data. High interlaboratory variation in numerical results and notable method-based variation, combined with a general lack of consensus in semiquantitative reporting, continues to be observed.

Multilaboratory testing of thrombophilia: current and past practice in Australasia as assessed through the Royal College of Pathologists of Australasia Quality Assurance Program for Hematology.

We have conducted a series of multilaboratory surveys during the last 6 years to evaluate testing proficiency in the detection of congenital and acquired thrombophilia. For lupus anticoagulant (LA) testing, participant laboratories used a panel of tests, including activated partial thromboplastin time (aPTT; 100% of laboratories), kaolin clotting time (26 to 70%), and Russell's viper venom time (RVVT; 75 to 100%). Coefficients of variation (CVs) for assays ranged from 5 to 40%.

Consensus guidelines on anti-cardiolipin antibody testing and reporting.

Unlabelled: Consensus guidelines on anti-cardiolipin antibody (aCL) testing have been developed to help minimise laboratory variation in the performance and reporting of aCL assays. These guidelines include minimum, optimum and optional recommendations for the following aspects of aCL testing and reporting: (1) isotype of aCL tested; (2) specimen type; (3) controls and assay precision; (4) calibrators; (5) patient samples; (6) rheumatoid factors and IgM aCL testing; (7) reporting of results; (8) cut-off values; and (9) interpretative comments.

Abbreviations: aCL, anti-cardiolipin antibodies; APS, anti-phospholipid antibody syndrome; ASCIA, Australasian Society of Clinical Immunology and Allergy; ASTH, Australasian Society of Thrombosis and Haemostasis; beta2-GPI=beta2-glycoprotein I; ELISA, enzyme-linked immunosorbent assay; NCCLS, National Committee for Clinical Laboratory Standards; HSANZ, Haematology Society of Australia and New Zealand; QAP, Quality Assurance Program; RCPA, Royal College of Pathologists of Australasia; %CV, inter-assay inter-run coefficient of variation.

Difficulties with the serologic diagnosis of infectious mononucleosis: a review of the RCPA quality assurance programs.

The Royal College of Pathologists of Australasia's Quality Assurance Programs (QAP) on serologic assays for infectious Mononucleosis (IM) have identified a number of important problems in laboratory diagnosis of this condition. A wide range of assays for the diagnosis of acute Epstein-Barr virus (EBV) infection are available, although heterophile antibody tests are still the most frequently performed procedures for the diagnosis of IM. In 1993, eighty-six (54%) of the 159 participating laboratories performed only a heterophile test; of these, 71% did not provide an interpretation of their results and none mentioned the need for confirmatory EBV-specific antibody testing.