Abstract Background Lupus Anticoagulants (LAs), one of the antiphospholipid antibodies, are risk factors for arterial or venous thrombosis with complications such as stroke, acquired thrombophilia, and pregnancy loss. Detection of LAs is challenging for laboratories as the heterogeneity of antibodies and epitopes on protein in the phospholipids. Thus, no single test is sensitive for all LAs, and the International Society on Thrombosis and Haemostasis Scientific and Standardization Committee (ISTH) recommended laboratory should provide two test systems based on different principles, which dilute Russell's viper venom time (dRVVT) should be as the major test, and partnered with LA-sensitive activated partial thromboplastin time (aPTT). There are many different mechanisms of tests proposed by various manufacturers, however, the comparison of different platforms by different manufacturers on LAs remains unknown. In this study, we aimed to evaluate the performance of various LA tests among different platforms. Methods A total of 76 specimens from September to December 2022 were collected. dRVVT (dRVVTIL) and silica clotting time (SCTIL) were performed by ACL TOP 500 analyzer (Instrumentation Laboratory, US). In addition, ellagic acid-based aPTT (Siemens Dade Actin FSL reagent, aPTTAFSL), silica-based aPTT (Siemens Pathromtin SL reagent, aPTTPSL), and dRVVT (dRVVTsysmex) were performed by Sysmex CN-6000 analyzer (Sysmex Corporation, Japan). Analytical performances, agreements, and McNemar's test were calculated. Results All 76 specimens were originally tested by dRVVTIL and SCTIL, and showed that 30 specimens were positive for both assays, 6 were only positive for dRVVT, 5 were only positive for SCT, and 35 specimens were negative for both assays. In addition, all samples were further tested by dRVVTsysmex. Compared with the integrated use of dRVVTIL and SCTIL, dRVVTsysmex showed 100.0% (41/41) positive agreement and 91.4% (32/35) negative agreement. 3 specimens could only be tested positive on the dRVVTsysmex platform, of which one patient was diagnosed with systemic lupus erythematosus (SLE), another patient was diagnosed with infertility, and the other patient was diagnosed with antiphospholipid syndrome (APS). To further evaluate the performance of aPTT on LA screening, 44 specimens with either dRVVTIL, SCTIL and dRVVTsysmex positive were considered LA-positive and further tested by different aPTT assays. The positive agreement was 65.9% (29/44; 95% CI: 50.1–79.5%) and 77.3% (34/44; 95% CI: 62.2–88.5%) on aPTTAFSL and aPTTPSL, respectively, however, there was no significant difference between the positive agreement of two assays (P = 0.13). Conclusion Compared with the integrated use of dRVVTIL and SCTIL, dRVVTsysmex could achieve the same detection rate on LA. Furthermore, aPTTAFSL and aPTTPSL showed no significant difference between the positive agreements for LA-positive specimens.
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