A multi‐laboratory assessment of lupus anticoagulant assays performed on the ACL TOP 50 family for harmonized testing in a large laboratory network

Favaloro, Emmanuel J.; Mohammed, Soma; Vong, Ronny; Chapman, Kent D.; Swanepoel, Priscilla; Kershaw, Geoffrey; Cai, Nancy; Just, Sarah; Connelly, Lynne M; Brighton, Timothy; Pasalic, Leonardo

doi:10.1111/ijlh.13818

Cited by 15 publications

(10 citation statements)

References 25 publications

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“…Some previous evaluations of ACL TOP instruments have been published, as also previously reported by us [6–8] but none discussed evaluation of factor assays on ACL TOPs, being instead largely focused on the preanalytical module for detection of haemolysis/icteria/lipaemia. Of some relevance perhaps, Falay et al [16] utilized an ACL TOP analyser to evaluate 166 patients with an isolated raised APTT, and SythASil APTT reagent in combination with repeat testing by Stago Cephascreen APTT on a Stago STAR analyser.…”

Section: Discussionmentioning

confidence: 98%

“…Normally, an acceptable and broadly manageable option [9] would be to verify NRRs provided by the manufacturer but this would require manufacturer NRRs to be established using ‘robust’ procedures. We used such a process in the past to verify use of certain NRRs for Instrumentation Laboratory/Werfen for routine coagulation [6], congenital thrombophilia assays [7], and lupus anticoagulant [8] testing. Unfortunately, factor assay NRRs reported by Instrumentation Laboratory/Werfen in product information refer to a dated textbook [10], so we felt this option inappropriate on this occasion.…”

Section: Methodsmentioning

confidence: 99%

“…We essentially confirmed ‘equivalence’ (or ‘interchangeability’) of all three TOP instrument types (350, 550, 750) in terms of assay results. More recently, we reported evaluations of congenital thrombophilia assays [7] and lupus anticoagulant [8] testing on the platform, using both Werfen and alternate reagents. The current manuscript reports a separate evaluation for factor assay testing in our network, to further enable standardization and harmonization of testing and procedures across NSWHP.…”

Section: Introductionmentioning

confidence: 99%

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Harmonizing factor assay-related testing performed in a large laboratory network

Favaloro

Mohammed

Vong

et al. 2022

Blood Coagulation &Amp; Fibrinolysis

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Coagulation factor testing is commonly performed within haemostasis laboratories, either to assess for bleeding disorders, such as haemophilia, or to investigate unexplained prolongation in routine coagulation assays. The aim of this evaluation was to harmonize procedures and normal reference ranges (NRRs) for investigation of coagulation factors on the ACL TOP 50 family of instruments in a large laboratory network. We employed comparative evaluations using newly installed ACL TOPs 550 and 750 and HemosIL reagents vs. existing ‘reference’ instrumentation and reagents, predominantly Stago and Siemens, as well as assessment of factor sensitivity in routine coagulation assays, prothrombin time (PT) and activated partial thromboplastin time (APTT). Also, establishment of coagulation factor NRRs using normal plasma samples. HemosIL factor assays showed good comparability with the existing reference methods (R > 0.9). Factor sensitivity for PT and APTT assays were acceptable at around 30 U/dl. NRRs were established and harmonized across the laboratory network. This evaluation of factor testing on ACL TOP 50 Family instruments identified overall acceptable performance using Werfen reagents and enabled harmonization of coagulation factor testing in our large network.

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Section: Discussionmentioning

confidence: 98%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Harmonizing factor assay-related testing performed in a large laboratory network

Favaloro

Mohammed

Vong

et al. 2022

Blood Coagulation &Amp; Fibrinolysis

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“…There were also some multicenter studies evaluating methods for LA testing, aiming to improve or harmonize LA testing across laboratory networks or groups. [21][22][23][24] We could not find any recent EQA-specific reports related to LA testing, with the first temporal report in our PubMed search being our own prior report from 2012. 10 As already noted, some contemporary findings replicate those we reported at that time, including the "generic" or "default" cut off of 1.2 for dRVVT screen/confirm to identify LA positivity.…”

Section: Literature Review and Comparison With Our External Quality A...mentioning

confidence: 90%

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

Favaloro,

Dean,

Arunachalam

2023

Semin Thromb Hemost

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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. Since no test can be considered 100% sensitive or specific for LA, current guidelines recommend using two different clot-based assays reflecting different principles, with the dilute Russell viper venom time (dRVVT) and activated partial thromboplastin time (aPTT) recommended. Initially, LA-sensitive reagents are used to screen for LA, and then, in “screen-positive” samples, LA-“insensitive” reagents are used to confirm LA. Because LA assays are based on clot detection, anything that can interfere with fibrin clot development may affect test results. In particular, in addition to LA, the tests are also sensitive to the presence of a wide range of clinical anticoagulants, reflecting preanalytical issues for testing. We provide updated findings for LA testing in our geographic region, using recent data from the Royal College of Pathologists of Australasia Quality Assurance Programs, an international external quality assessment program with approximately 120 participants. Data show a wide variety of assays in use, especially for aPTT testing, and variable outcomes in reported numerical values with these assays when assessing proficiency samples. dRVVT testing mostly comprised reagents from three main manufacturing suppliers, which also showed differences in numerical values for the same homogeneous tested samples. Nevertheless, despite the use of different test reagents and processes, >98% of participants correctly identified LA-negative samples as LA-negative and LA-positive samples as LA positive. We hope our findings, reflecting on the heterogeneity of test processes and test data, help improve diagnostic testing for LA in the future.

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“…Our two Stago StaR Evolutions were replaced with two ACL-TOP 750 instruments and the Stago instruments decommissioned. Our Westmead laboratory was at the forefront of the statewide instrumentation and test methodology verification process [41][42][43][44][45] and also led several other NSWHP-harmonization initiatives, including for the PFA-100/-200. 46 ►Table 3 provides a list of hemostasis tests currently performed by the Westmead laboratories.…”

Section: Evolution Of Hemostasis Testing-the Contemporary 2020'smentioning

confidence: 99%

Evolution of Hemostasis Testing: A Personal Reflection Covering over 40 Years of History*

Favaloro

2023

Semin Thromb Hemost

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There is no certainty in change, other than change is certain. As Seminars in Thrombosis and Hemostasis celebrates 50 years of publication, I felt it appropriate to reflect on my own 40-year plus scientific career. My career in the thrombosis and hemostasis field did not start until 1987, but the subsequent 35 years reflected a period of significant change in associated disease diagnostics. I started in the Westmead Hospital “coagulation laboratory” when staff were still performing manual clotting tests, using stopwatches, pipettes, test tubes, and a water bath, which we transported to the hospital outpatient department to run our weekly warfarin clinic. Several hemostasis instruments have come and gone, including the Coag-A-Mate X2, the ACL-300R, the MDA-180, the BCS XP, and several StaR Evolution analyzers. Some instruments remain, including the PFA-100, PFA-200, the AggRAM, the CS-5100, an AcuStar, a Hydrasys gel system, and two ACL-TOP 750s. We still have a water bath, but this is primarily used to defrost frozen samples, and manual clotting tests are only used to teach visiting medical students. We have migrated across several methodologies in the 45-year history of the local laboratory. Laurel gel rockets, used for several assays in the 1980s, were replaced with enzyme-linked immunosorbent assay assays and most assays were eventually placed on automated instruments. Radio-isotopic assays, used in the 1980s, were replaced by an alternate safer method or else abandoned. Test numbers have increased markedly over time. The approximately 31,000 hemostasis assays performed at the Westmead-based laboratory in 1983 had become approximately 200,000 in 2022, a sixfold increase. Some 90,000 prothrombin times and activated partial thromboplastic times are now performed at this laboratory per year. Thrombophilia assays were added to the test repertoires over time, as were the tests to measure several anticoagulant drugs, most recently the direct oral anticoagulants. I hope my personal history, reflecting on the changes in hemostasis testing over my career to date in the field, is found to be of interest to the readership, and I hope they forgive any inaccuracies I have introduced in this reflection of the past.

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A multi‐laboratory assessment of lupus anticoagulant assays performed on the ACL TOP 50 family for harmonized testing in a large laboratory network

Cited by 15 publications

References 25 publications

Harmonizing factor assay-related testing performed in a large laboratory network

Harmonizing factor assay-related testing performed in a large laboratory network

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

Evolution of Hemostasis Testing: A Personal Reflection Covering over 40 Years of History*

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