Comparison of "Lumipulse anti-Treponema pallidum" and "Architect Syphilis TP" and further examination.

BACKGROUND: Syphilis is a sexually transmitted disease caused by Treponema pallidum (TP) infection. In recent years, diagnostic reagents with fully automated immunoassay instruments have become mainstream. However, these positive screening tests with high sensitivity, which are performed with full automation, need confirmation by Treponema pallidum particle agglutination (TPPA) to be judged as positive. METHODS: We evaluated the diagnostic performance of Lumipulse G TP-N assay (Lumi-TP, Fujirebio Inc) in 223 preselected TP-positive samples and 1041 TP-negative samples, compared it with that of the TP gold standard test (TPPA) and Architect Syphilis TP test (Archi-TP, Abbott). RESULTS: The concordance rates for the results for the positive and negative samples between Lumi-TP and TPPA were 100%. On the other hand, the rates for the results between Archi-TP and TPPA were 100% for positive samples and 99.14% (1032/1041) for negative samples. Correlation tendency and rate between Archi-TP and Lumi-TP were 2.549 and 0.841 in positive specimens up to 160 detected values in Lumi-TP. However, the detection value of Archi-TP reached a plateau when it exceeded about 40. Furthermore, according to the comparison of each value obtained from Archi-TP and Lumi-TP with the strength of the staining of each line in the immune-chromatography assay kit, ESPLINE TP (Fujirebio Inc) for TP major antigens, Tp15-17 and TpN47, it was found that Lumi-TP obtained higher values than Archi-TP, particularly for TpN 47. CONCLUSIONS: Lumi-TP has high specificity and is useful not only for screening but also for determining the amount of anti-TP antibodies.

Value of serum human epididymis secretory protein 4 as a marker for differential diagnosis of malignant and benign gynecological diseases of patients in southern China.

BACKGROUND: This study investigated the clinical value of HE4 in distinguishing malignant and benign gynecological diseases of patients in southern China. METHODS: Preoperative serum CA125 and HE4 concentrations were tested in samples of women with malignant or benign gynecological diseases using fully automated methods (Abbott ARCHITECT) and validated cutoff values. RESULTS: For the discrimination of ovarian cancer from benign gynecological diseases, in premenopausal women, the sensitivity and specificity were 89.8% and 67.5% for CA125, 68.5% and 97.8% for HE4, and 88.9% and 78.6% for ROMA, whereas in postmenopausal women, the sensitivity and specificity were 86.6% and 88.9% for CA125, 57.3% and 100% for HE4, and 85.4% and 94.4% for ROMA. For the discrimination of endometrial cancer from benign gynecological diseases, in premenopausal women, the sensitivity and specificity were 20.3% and 67.5% for CA125, 56.8% and 97.8% for HE4, and 74.3% and 78.6% for ROMA, whereas in postmenopausal women, the sensitivity and specificity were 17.8% and 88.9% for CA125, 31.5% and 100% for HE4, and 32.9% and 94.4% for ROMA. CONCLUSIONS: We showed that HE4 had better specificity than CA125 in discriminating ovarian cancer, and endometrial cancer from benign gynecological diseases in southern China population.

Elevated serum concentrations of HE4 as a novel biomarker of disease severity and renal fibrosis in kidney disease.

BACKGROUND: Human epididymis protein 4 (HE4), has recently been reported as a mediator of renal fibrosis. However, serum HE4 levels appear in a large number of patient samples with chronic kidney disease (CKD), and the relationship of these levels to disease severity and renal fibrosis is unknown. METHODS: In 427 patients at different stages of CKD excluding gynecologic cancer and 173 healthy subjects, serum HE4 concentrations were tested by chemiluminescent microparticle immunoassay. Renal biopsy was performed on 259 of 427 subjects. Histological findings were evaluated using standard immunohistochemistry. RESULTS: The levels of serum HE4 were higher in CKD patients than in healthy subjects, and higher levels were associated with more severe CKD stages. Patients with more severe renal fibrosis tended to have higher HE4 levels, and correlation analysis showed a significant correlation between HE4 and degree of renal fibrosis (r = 0.938, P < 0.0001). HE4 can be a predictor of renal fibrosis in CKD patients; the area under the receiver-operating characteristic curve (AUC-ROC) was 0.99, higher than the AUC-ROC of serum creatinine (0.89). CONCLUSION: Elevated levels of serum HE4 are associated with decreased kidney function, and also with an advanced stage of renal fibrosis, suggesting that HE4 may serve as a valuable clinical biomarker for renal fibrosis of CKD.