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Category: Lupus Anticoagulant

In Vitro LA Mechanism

From Kathy Doig, PhD, Michigan State University (Go Spartans!). George – what is the current thinking on how antiphospholipid antibodies (lupus anticoagulants, LAs)  interfere with our assays?  Does the antibody physically block the proteins so they can’t react properly even though they embed in the phospholipids (PLs)?  Does it prevent them from embedding in the PLs as they should?  Or is it something else entirely?

Dr. Doig gets these penetrating questions from her graduate students, sending us back to the books for answers. Here is George’s effort at a reply:

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What is an LDT?

From Kelly Townsend, Tri-core Reference Laboratories, Albuquerque. Looking for opinions on what constitutes a “Laboratory Developed Test” in Coag. Obviously if the reagent kit is not FDA-cleared, it will be an LDT, but what about factor assays, etc where there is no real kit. What if you are using a kit with a different calibrator or control than the manufacturer sells/endorses? Having trouble coming up with a concise definition for LDT. Thanks, Kelly.

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DRVVT Reagent Stability

From Dave McGlasson, George, Has anyone got information on storing DRVV screen and confirm reagent aliquots?  Can you freeze/thaw them without any loss in activity?  That question has come up to me recently.

Revalidating Sta-Clot LA

From Rose Markarian, Supervisor Hematology,  Saint John’s Health Center, Santa Monica, CA: Hi George, We perform Stago’s confirmatory hexagonal phase Sta-Clot LA test for lupus inhibitor testing. We validated Stago’s recommended cut off value of ≤ 8.0 seconds several years ago when the test was implemented. Do we have to validate the cut off value with each new lot of reagent? Please advise.
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Factor VIII Inhibitor?

From Deborah Whetzel, Children’s Hospital of the King’s Daughters, Norfolk, VA: We’ve had a couple patients lately that demonstrated inhibition but their factor VIII results are within normal limits or even elevated. The result values differ 30–40% typically between dilutions but as they’re diluted more, the values go up to 300 or 400%. FVIII values that high seem really odd to me. We dilute to 1:160, as I’ve seen recommended, with results to that point continuing to get higher. Have you seen this occur and is there something that we should be doing? Thanks for your help.

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Positive DRVVT when Mixing Study Corrects

From Aliaa Amer: Hi George, we are using Actin FSL for our routine activated partial thromboplastin time (APTT, PTT). Whenever we get a prolonged APTT that is >5 s above the upper limit of the norm range we do mixing studies, both immediate and 2 h incubation using 1:1 and 4:1 mix, the latter to detect weak lupus anticoagulant (LA). In many instances we get full correction and we proceed to factor assays which turn out to be normal. Then we test for LA using the dilute Russell viper venom time (DRVVT). To our surprise we find it is positive for a mild LA (LAS/LAC = 1.5, our cut off is 1.2) which could not be detected even by the 4:1 preparation. Do you have any explanation for this? We are using the Siemens BCS analyzer.

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More on “Unexpected DRVVT Results”

Here is a message about the dilute Russell viper venom time assay (DRVVT) for lupus anticoagulant (LA) from international expert Thomas Exner, HAEMATEX, Sydney, Australia:

It was a pleasure to meet you at the International Society on Thrombosis and Haemostasis (ISTH) meeting recently. I would like to respond an interesting question raised on July 16, 2013 in your Fritsma Factor website. Best wishes.

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Establishing StaClot LA Limit

From Bonnie Brozak-Sarandos, MT(ASCP)SH, Hematology and Coagulation Technical Specialist, ProHealth Care Laboratories, Waukesha Memorial Hospital:

Hi George,  When performing the Staclot lupus anticoagulant (LA) test, the difference between Staclot 1 and Staclot 2 used to use a cutoff value of 8 seconds. We have been told by the reagent manufacturer that we should establish our own cutoff with each new lot number and use 4sd above the mean . The reagent supplier suggested using either purchased normal donor samples or using our own patient population. Using our purchased normal donors we now have a cutoff of 10.8 seconds. When we use a mixture of our normal patients and some purchased normal donors, it rises to 16.0. This is a big difference, and it is exactly what the reagent supplier said would happen, but what is right? What is the right way to establish this important cutoff? What about the patient who falls between 10.8 and 16.0? Just wondering if you know what others are doing or what experience you have with this change.

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