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The Clinical Performance of a New Chemiluminescent Immunoassay in Measuring Anti-?2 Glycoprotein 1 and Anti-Cardiolipin Antibodies.

ABSTRACT: BACKGROUND Laboratory criterion is needed for the classi?cation of antiphospholipid syndrome (APS), which contain anticardiolipin antibodies (aCL) and anti-?2-glycoprotein 1 antibodies (a?2GP1). They are commonly identified by enzyme-linked immunosorbent assay (ELISA), but lack standardized kits, resulting in substantial variations in the antibody positivity between different laboratories. The emergence of chemiluminescence automated -BIO-FLASH may improve the situation. MATERIAL AND METHODS We selected 185 patients with APS, systemic lupus erythematosus (SLE), infertility, connective tissue disease (CTD), and other conditions in Peking University Third Hospital. We tested the aCL and a?2GP1 levels by EUROIMMUN ELISA and 105 patients had at least one positive result for aCL and a?2GP1, while the others had negative results. We retested them by chemiluminescence assay (CIA) and analyzed the result and compared the coincidence rate. The IgM levels were retested by AESKU ELISA. Data were analyzed using SPSS. RESULTS Our result suggested that CIA had good performance for IgG isotype of aCL and a?2GP1 in the coincidence rate. The positive coincidence rate of aCL IgM between CIA and EUROIMMUN ELISA was only 41.67%, but two ELISA kits showed good coincidence, CIA and AESKU ELISA had an obviously higher positive rate. CIA and AESKU had a higher coincidence than that of AESKU and EUROIMMUN in a?2GP1-IgM. CONCLUSIONS The new automated CIA BIO-FLASH is suitable for detecting aCL and a?2GP1 antibodies, especially IgG isotype, which may provide an alternative to time-consuming conventional ELISA method.

SUBMITTER: Zhou J

PROVIDER: S-EPMC6180949 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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The Clinical Performance of a New Chemiluminescent Immunoassay in Measuring Anti-β2 Glycoprotein 1 and Anti-Cardiolipin Antibodies.

Zhou Jiansuo J Hou Xiuzhu X Zhang Hua H Wang Tiancheng T Cui Liyan L

Medical science monitor : international medical journal of experimental and clinical research 20180926

BACKGROUND Laboratory criterion is needed for the classiﬁcation of antiphospholipid syndrome (APS), which contain anticardiolipin antibodies (aCL) and anti-β2-glycoprotein 1 antibodies (aβ2GP1). They are commonly identified by enzyme-linked immunosorbent assay (ELISA), but lack standardized kits, resulting in substantial variations in the antibody positivity between different laboratories. The emergence of chemiluminescence automated -BIO-FLASH may improve the situation. MATERIAL AND METHODS We ...[more]

PMID: 30256771

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Project description:BackgroundEnzyme-linked immunosorbent assay (ELISA) has traditionally been used to detect myeloperoxidase (MPO) and proteinase 3 (PR3) antibodies, although it is time-consuming and physically demanding. As a novel and highly effective immunoassay, we compared chemiluminescent immunoassay (CIA) with ELISA to verify the application value of CIA in MPO and PR3 antibodies detection.MethodsBy ELISA and CIA, serum levels of anti-MPO and anti-PR3 antibodies were measured in 63 anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) patients (AAV group), including 47 microscopic polyangiitis (MPA) patients and 16 granulomatosis with polyangiitis (GPA) patients, in addition, 68 patients in interference control group (IC group), 19 healthy subjects in healthy control group (HC group). We compared MPO and PR3 antibodies levels and positive rates measured by these two methods among groups. Relationship and coincidence rate between ELISA and CIA were investigated. Diagnostic values for clinical outcomes for MPO and PR3 antibodies were assessed by receiver operator characteristic (ROC) curve.ResultsIn AAV patients, when detecting anti-MPO (r = .90) and anti-PR3 (r = .81), CIA was highly correlated with ELISA, companying with highly total (88.89%, 92.06%, respectively) and positive coincidence rates (84.78%, 77.27%, respectively). In HC group, anti-PR3 positive rate detected by both immunoassay were 0, anti-MPO almost were 0, which without statistically significant difference (P = .32). In IC group, the total (76.47%, 58.82, respectively) and positive coincidence rates (48.38%, 30.00%, respectively) of anti-MPO and anti-PR3 were the lowest, but the negative coincidence rates reached 100%. By CIA, similar to ELISA, the levels of anti-MPO were significantly higher both in AAV patients (56.00; [4.40-235.30]) and MPA patients (98.00; [27.90-324.70]) compared with either IC group (3.20; [3.20-18.55) (P < .0001) or HC group (3.20; [3.20-3.20]) (P < .0001), yielded an area under curve (AUC) of 0.76 for AAV and 0.89 for MPA, the concentration of anti-PR3 in GPA group (66.65; [24.43-150.00]) was significantly higher than that in IC group (2.3; [2.3-10.95]) (P < .0001) and HC group (2.3; [2.3-2.3]) (P < .0001), with an AUC of 0.92.ConclusionSimilar to ELISA, CIA was competent to detect MPO and PR3 antibodies in AAV patients and healthy population, thus distinguish AAV patients from IC group and HC group and effectively diagnose MPA and GPA.

Project description:Varicella and herpes zoster are mild symptoms-associated diseases caused by varicella-zoster virus (VZV). They often cause severe complications (disseminated zoster), leading to death when diagnoses and treatment are delayed. However, most commercial VZV diagnostic tests have low sensitivity, and the most sensitive tests are unevenly available worldwide. Here, we developed and validated a highly sensitive VZV diagnostic kit based on the chemiluminescent immunoassay (CLIA) approach. VZV-glycoprotein E (gE) was used to develop a CLIA diagnostic approach for detecting VZV-specific IgA, IgG, and IgM. The kit was tested with 62 blood samples from 29 VZV-patients classified by standard ELISA into true-positive and equivocal groups and 453 blood samples from VZV-negative individuals. The diagnostic accuracy of the CLIA kit was evaluated by receiver-operating characteristic (ROC) analysis. The relationships of immunoglobulin-isotype levels between the two groups and with patient age ranges were analyzed. Overall, the developed CLIA-based diagnostic kit demonstrated the detection of VZV-specific immunoglobulin titers depending on sample dilution. From the ELISA-based true-positive patient samples, the diagnostic approach showed sensitivities of 95.2%, 95.2%, and 97.6% and specificities of 98.0%, 100%, and 98.9% for the detection of VZV-gE-specific IgA, IgG, and IgM, respectively. Combining IgM to IgG and IgA detection improved diagnostic accuracy. Comparative analyses on diagnosing patients with equivocal results displaying very low immunoglobulin titers revealed that the CLIA-based diagnostic approach is overall more sensitive than ELISA. In the presence of typical VZV symptoms, CLIA-based detection of high titer of IgM and low titer of IgA/IgG suggested the equivocal patients experienced primary VZV infection. Furthermore, while no difference in IgA/IgG level was found regarding patient age, IgM level was significantly higher in young adults. The CLIA approach-based detection kit for diagnosing VZV-gE-specific IgA, IgG, and IgM is simple, suitable for high-throughput routine analysis situations, and provides enhanced specificity compared to ELISA.

Dataset Information

The Clinical Performance of a New Chemiluminescent Immunoassay in Measuring Anti-?2 Glycoprotein 1 and Anti-Cardiolipin Antibodies.

Publications

The Clinical Performance of a New Chemiluminescent Immunoassay in Measuring Anti-β2 Glycoprotein 1 and Anti-Cardiolipin Antibodies.

Similar Datasets

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