September 2024

THE CEPHEN SYSTEM – SHINING THE LIGHT ON LA  

INTEGRATION  

CEPHEN™ LS (regularly scores highly in the ECAT and RCPAQAP surveys on testing for lupus anticoagulant (LA). Together with the LA resistant version CEPHEN™ (both from Hyphen BioMed, France) it forms an integrated system for LA testing as recommended by most guidelines (such ISTH (International), CLSI (also International but mostly USA) and BSH (British)). The CEPHEN™ LS/CEPHEN™ combination is one  of a few truly integrated systems for APTT (Favaloro EJ, Dean E, Arunachalam S. Variable Performance of Lupus Anticoagulant Testing: The Australasian/Asia-Pacific Experience. Semin Thromb Hemost. 2023 Nov 15. doi: 10.1055/s-0043-1776406). https://pubmed.ncbi.nlm.nih.gov/37967835/

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COMBINATION

In the recent IJLH study of 249 samples, Adrien Thiriet and coworkers found that the CEPHEN™ SYSTEM had 49% sensitivity towards LA as defined by a combination of Stago-based dRVVT Screen/Confirm and the PTT-A (also from Stago). This may seem low but when combined with the dRVVT testing Screen/Confirm ratio, LA sensitivity reached 89%. This is almost identical to results obtained by Osamu Kumano and Gary Moore in 2019 (Kumano O, Amiral J, Dunois C, Peyrafitte M, Moore GW. Paired APTTs of low and high lupus anticoagulant sensitivity permit distinction from other abnormalities and achieve good lupus anticoagulant detection rates in conjunction with dRVVT. Int J Lab Hematol. 2019 Feb;41(1):60-68. doi: 10.1111/ijlh.12921). https://pubmed.ncbi.nlm.nih.gov/30248243/  Except that the latter study reported 95% sensitivity.

AUTOIMMUNE LA  

What is most interesting about the Thiriet study is that they looked at the LA patients’ clinical issues such as CRP and autoimmune disease profiles as well as the dRVVT and APTT results. They found that “dRVVT tended to be significantly more frequently positive when CRP was elevated”. Also, that “the samples for whom CEPHEN™ LS/CEPHEN™ were positive and dRVVT was negative were issued from patients who were, for most of them, suffering from conditions such as APS or SLE for which the prevalence of LA is significant”.  They also noted the discrepancy between their study and prior studies ("that ...CEPHEN™ LS/CEPHEN™ positivity did not significantly increase when CRP was positive, unlike other aPTTs)."

This seems to suggest that the CEPHEN™ SYSTEM may be more specific for the more clinically-relevant autoimmune LA than other test systems. This brings to mind the recent excitement about LA being frequently detected in COVID-19 patients (Favaloro EJ, Henry BM, Lippi G. Is Lupus Anticoagulant a Significant Feature of COVID-19? A Critical Appraisal of the Literature. Semin Thromb Hemost. 2022 Feb;48(1):55-71. doi: 10.1055/s-0041-1729856). https://pubmed.ncbi.nlm.nih.gov/34130341/ CRP is also greatly increased in this condition.  

OTHER CEPHEN™ NEWS…..STRASBOURG

An evaluation of CEPHEN™ APTT reagents has recently been carried out by a hospital group in Strasbourg and may be of interest to the increasing numbers of local users. (Evaluation of an integrated activated partial thromboplastin time (CEPHEN™ LS/CEPHEN™) for the detection of lupus anticoagulant. Thiriet A, Poindron V, Sattler L, et al. Int J Lab Hematol 2024:1-9). https://pubmed.ncbi.nlm.nih.gov/39102215/

PRODUCTS

The CEPHEN™ SYSTEM is growing in use in Australian coag labs with the most popular combination of:

CK512K           CEPHEN™ 2.5
CK522K           CEPHEN™ 2.5 LS

The CEPHEN™ LR is also available in the larger size,  CK515L CEPHEN™ 5.  

To complement your CEPHEN™ SYSTEM, we have a range of Hyphen LA control plasmas:

SC081K           LA Control Plasma
SC082K           LA Control Plasma Weak
SC083K           LA Control Plasma High

For further info/ordering your CEPHEN™ SYSTEM,  contact us at htx@haematex.com .

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Haematex is the only Australian distributor which carries out local R&D into coagulation diagnostics. When you purchase from us, a portion of profits go towards projects such as our own locally made DOAC-Stop™, and research on dRVVT and lupus anticoagulants. We hope this newsletter has been of interest, if you do not wish to receive future updates, please let us know.