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PubMed1990

Special report. The Second International Anti-cardiolipin Standardization Workshop/the Kingston Anti-Phospholipid Antibody Study (KAPS) group.

Forty-three laboratories in 13 countries participated in a workshop to determine the degree of agreement between laboratories performing anticardiolipin tests. Each laboratory received freeze-dried aliquots of three samples labeled G1 (107 GPL units), G2 (20 GPL units), and G3 (6 GPL units) to be used as reference standards in the IgG assay, and three samples labeled M1 (106 MPL units), M2 (21 MPL units), and M3 (5 MPL units) as references for the IgM assay. Participating laboratories were divided into 8 groups and serum samples were exchanged between laboratories in each group. For IgG anticardiolipin, results were reported as: high, IgG positive for samples with optical absorbance readings exceeding G1; medium, IgG positive for samples with readings between G1 and G2; low, IgG positive between G2 and G3, and negative, if less than G3. In like manner, samples were defined as high-, medium-, or low-IgM positive, with reference to standards M1, M2, and M3. An index of agreement was computed to determine the degree of agreement between laboratories in each group. Interlaboratory agreement was excellent in each category assessed. For high positive and negative IgG and IgM results, the index of agreement exceeded 90%, and for medium and low positive results, agreement exceeded 75%. The overall index of agreement between laboratories exceeded 90%. The researchers conclude that the use of these six standards to obtain a semiquantitative measure of anticardiolipin positivity will enable good interlaboratory agreement in reporting anticardiolipin results.

Antibodies↗
PubMed2003

Comparison of different kits in the detection of autoantibodies to cardiolipin and beta2glycoprotein 1.

OBJECTIVE: To estimate the performance characteristics of 10 commercial kits and one in-house kit for the detection and quantification of anticardiolipin (aCL) (six kits) and anti-beta2glycoprotein 1 (anti-beta2GP1) (five kits) antibodies, and to evaluate the degree of variability between these different kits. METHODS: We determined the presence of aCL and anti-beta2GP1 IgG and IgM antibodies in 67 sera from 62 patients and reviewed the data separately. Each serum sample was tested with six commercial aCL determination kits and with four commercial and one in-house anti-beta2GP1 determination kit. We then analysed the operating characteristics of each kit (sensitivity, specificity, positive and negative predictive values) and we analysed the absolute and 2 x 2 agreements. RESULTS: The 62 patients included had primary antiphospholipid syndrome (APS) in 10 cases, secondary APS for eight, systemic lupus (SLE) for 23 and other diagnoses for the remaining 21. Operating characteristics differed from one kit to another. Good agreement was found using sensitive aCL determination kit and specific anti-beta2GP1 determination kit. Agreement between kits was medium for IgG aCL. 2 x 2 concordance studies showed a group of three aCL kits which were quite homogenous and showed that all anti-beta2GP1 kits formed quite a homogenous group. CONCLUSION: A high degree of variability still persists for aCL antibody determination posing the question of the qualification of commercial or in-house kits and the question of standardization of results. A better concordance is found for high positive results. Good agreement exists for anti-beta2GP1 kits. aCL determination is still needed and should be complemented by anti-beta2GP1 determination.

Antiphospholipid Syndrome↗
PubMed1988

Autoimmune cardiolipin-binding antibodies in oral anticoagulant patients.

In a routine clinic of patients taking regular oral anticoagulant therapy (warfarin, n = 140) 14% were found to have elevated levels (greater than 4 SD above normal) of anticardiolipin antibody (ACA) assessed by a well standardised enzyme linked immunosorbent assay (ELISA). There was a higher incidence of raised ACA in patients being treated for thrombotic episodes (9/47 = 19%) than in cases with heart valve replacements (8/75 = 11%). Furthermore, the highest ACA titres were in younger patients with thromboses scheduled for short-term anticoagulant treatment. Borderline DNA binding studies, together with some positive ANA results, suggested autoimmune etiology in the minority of these cases. Lupus anticoagulant was strongly detectable in only one such patient. The ACA were predominantly IgG (14/17) and did not appear to compromise the conditions of patients while on anticoagulant therapy. Raised ACA may be a highly significant marker for an acquired prothrombotic state.

Administration, Oral↗