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Update on Lupus Anticoagulant Testing Guidelines
As per the International Society for Thrombosis and Haemostasis Scientific and Standardization Committee (ISTH SSC) for Lupus Anticoagulants [1] |
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| Guideline Highlights: | |
| “Double centrifugation of the sample should be performed to ensure that the sample is platelet poor.” Samples should be frozen quickly (if testing is delayed) and should be thawed in a 37°C water bath. “Filtering samples is not recommended.” | |
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| CRYOcheckTM Lupus Positive Control is intended for use as a positive control in assays for lupus anticoagulants (LA). CRYOcheck Lupus Positive Control contains plasma from donors confirmed to have circulating LA. |  |
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| Guideline Highlights: | |
| “The risk of false-positive results is increased to an unacceptable level if more than two screening tests are performed.” Diluted Russell Viper Venom time (dRVVT) and the aPTT with silica as an activator and low phospholipids are the two screening tests of choice. | |
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| CRYOcheckTM LA CheckTM is a highly sensitive dRVVT screening reagent that can be used in conjunction with CRYOcheck LA SureTM as part of a comprehensive lupus anticoagulant testing panel as recommended by the ISTH SSC. |  |
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| Guideline Highlights: | |
| The pooled normal plasma used in the mixing test should contain minimal residual platelets (<107 mL-1) and approximately 100% activity for all clotting factors. Pooled normal plasma must be stored frozen in small aliquots. Commercial frozen normal plasmas can be used if they fulfill the above specifications. | |
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| CRYOcheckTM Pooled Normal Plasma is a frozen pool of plasmas from at least 20 carefully screened normal donors. Each lot is tested to ensure that all clotting factors are normal and the final product contains less than 10,000 platelets per µL as recommended by the ISTH SSC. |  |
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| Guideline Highlights: | |
| Confirmatory test(s) must be performed by increasing the concentration of phospholipids (PL) of the screening test. “Bilayer or hexagonal (II) phase phospholipids should be used to increase the concentration of PL.” | |
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| CRYOcheckTM LA SureTM is a phospholipid-rich dRVVT confirmatory reagent that can be used in conjunction with CRYOcheckTM LA CheckTM as part of a comprehensive lupus anticoagulant testing panel as recommended by the ISTH SSC. |  |
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| Guideline Highlights: | |
| "Results should be expressed as ratio of patient-to-pooled normal plasma for all procedures (screening, mixing and confirm).” | |
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| CRYOcheckTM Pooled Normal Plasma is a frozen pool of plasmas from at least 20 carefully screened normal donors. Each lot is tested to ensure that all clotting factors are normal and the final product contains less than 10,000 platelets per µL as recommended by the ISTH SSC. | |
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| Guideline Highlights: | |
| “LA test results should be reported with quantitative results, and an interpretative comment that indicates whether the findings are compatible with the presence/absence of LA.” | |
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| CRYOcheckTM Weak Lupus Positive Control is intended for use as a positive control in assays for lupus anticoagulants (LA). It contains plasma from donors confirmed to have circulating LA and is a weak positive LA control that challenges an assay's sensitivity to LA, allowing users to be confident that weak LA positive patient samples will be accurately detected. |  |
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Email requestlaguide@precisionbiologic.com for a copy of the guidelines.
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