| BackgroundAntiphospholipid syndrome (antiphospholipid syndrome, APS) is a non-inflammatory autoimmune disease, the clinical arterial, venous thrombosis, pathological pregnancy (early abortion and late fetal death) and thrombocytopenia symptoms such as performance, present in the serum antiphospholipid antibodies (antiphospholipid antibody, aPL), these symptoms may be used alone or more co-exist. APS diagnosis is mainly based on laboratory standards strictly defined criteria. But continued highly positive aPL patients are rare, a large number of patients with recurrent early abortion is a low degree of positive aCL or LA, or only anti-β2GP1 positive, and then define the pure obstetric APS (Nimes Obstetricians and Haematologists Antiphospholipid Syndrome, NOH also known as atypical-APS antiphospholipid syndrome).But for all laboratory tests to detect aPL show standardization poor. For ACL and A-β2GPI, some analysts question (ie, source and type of antigen, calibration and quantitative methods, the critical value, the resulting expression), analysis of the problem (ie, reporting and interpretation of results). Laboratory testing anti-cardiolipin antibodies (ACL) and anti-β2-glycoprotein I antibodies (A-β2GPI) autoantibodies face many common problems:lack of reference standards and the specific testing needs assessment for each laboratory-cut-off value.ObjectivesThe purpose of this study was to evaluate the upper limit for the reference range (ninth nineteen) ACL and A-β2GPI Shandong Provincial Hospital and acquire new reference ranges (ninetieth percentile, ninety-fifth percentile and ninety-ninth percentile) and analyze the performance of newly acquired investigate the reference range, further guidance on the treatment of patients with recurrent miscarriage.Patients and methodsWe examined 121 cases of serum samples of healthy subjects in the ACL and A-β2GPI, except history of thrombosis, pregnancy complications, tumors, infections and/or autoimmune disease (121 subjects were healthy women of childbearing age). All healthy subjects were from Shandong Provincial Hospital health examination center. We tested the commercial test used in our hospital (ie EUROIMMUN ELISA). In addition to the 20 serum samples were evaluated, including 10 cases of anti-phospholipid syndrome (APS) patients,10 healthy subjects, the new reference detector obtained range of analytical performance.IgG and IgM ACL and A-02GPI in the provincial hospital laboratory laboratory use commercial analytical measurements (ie EUROIMMUN ELISA). ACL test results with the GPL and MPL representation and a-b2gpi result of using arbitrary units (Au/ ml). Using CLSI (Clinical and Laboratory Standards Institute Clinical And Laboratory Standards Institute) is a reliable method for medical and statistical software (SPSS) calculation, calculation ninetieth percentile, ninety-fifth percentile and ninety-ninth percentile. Background on the clinical sensitivity and specificity were calculated. Using Fisher exact test the relationship between the two classification systems (sick/ healthy, positive/negative). P values less than 0.05 were considered statistically significant.Results:ACL and A-β2GPI levels in 121 healthy subjects reference range (ninetieth percentile median, the ninety-fifth percentile and ninety-ninth percentile) of the reference value (Table 6).30 regular schools are concerned, the cut-off value calculated according to the new reference ranges and manufacturers to give specificity and sensitivity, anti-cardiolipin antibodies shows a significant difference (p<0.05); anti-glycoprotein I antibodies-β2 no significant difference (p> 0.05) (Table 5).Conclusion:In conclusion,reference range using commercially available kits and values reported by different manufacturers. In addition, the normal reference value calculation IgG and IgM ACL is different from any of the selected laboratory classification recommended. |
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