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Objective To evaluate Aptima HPV E6 and E7 mRNA assay (Aptima HPV) combined with Aptima HPV 16 and 18 or 45 (18/45) genotype assay (Aptima HPV-GT) as a means of cervical cancer opportunistic screening. Methods From October 2016 to October 2017, a total of 23 258 women aged 25-65 years were enrolled in the physical examination center and gynecological clinic of Huzhou Maternity and Child Health Care Hospital. All the women had Aptima HPV tested, further Aptima HPV-GT testing for positive women and liquid-based thin layer cytology Thinprep cytologic test (TCT). Women with Aptima HPV (+) or ≥low-grade squamous intraepithelial lesion (LSIL) or obvious clinical symptoms (including vaginal bleeding after intercourse and watery, bloody vaginal discharge) were referred for colposcopy and further biopsy with or without endocervical curettage (ECC) if indicated. Expression of Aptima HPV, HPV 16 and HPV 18/45 with different cytological diagnostic groups and histological diagnosis groups were compared respectively. Sensitivity, specificity, positive predictive value and negative predictive value of Aptima HPV detection and TCT in identifying histological diagnosis of high-grade squamous intraepithelial lesion (HSIL) or worse (HSIL+) were compared. Results (1) The positive rates of Aptima HPV, HPV 16 and HPV 18/45 were 14.00% (3 257/23 258), 1.85% (430/23 258) and 0.86% (199/23 258) respectively.The positive rates of Aptima HPV, HPV 16 and HPV 18/45 increased with cytology grading in squamous epithelium [negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASCUS), LSIL, atypical squamous cell cannot exclude HSIL (ASC-H), HSIL and squamous cell carcinoma (SCC), all P=0.000)]. According to histology results, the positive rates of Aptima HPV, HPV 16 and HPV 18/45 increased with histology grading in squamous epithelium (normal cervical tissue, LSIL, HSIL and SCC, all P=0.000). The positive rate of Aptima HPV was significantly higher in HSIL+group than that in the LSIL or better (LSIL-) group [98.11% (311/317) vs 12.84% (2 946/22 941), P=0.000]. The positive rate of Aptima HPV-GT was significantly higher in HSIL+group than that in LSIL-group [58.36% (185/317) vs 1.91% (439/22 941), P=0.000]. (2) Compared with cytology, Aptima HPV resulted in significant higher sensitivity (98.11% vs 59.62%, P=0.000) and negative predictive value (99.97% vs 99.42%, P=0.000), significant lower specificity (87.16% vs 95.37%, P=0.000) and positive predictive value (9.55% vs 15.10%, P=0.000) when identified HSIL+. Conclusions Women with Aptima HPV positive, especially those with Aptima HPV-GT positive, are more likely to have histological diagnosis of HSIL+. Aptima HPV combined with Aptima HPV-GT is feasible as a means of cervical cancer opportunistic screening in tertiary hospitals.
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Objective To explore the methods of preparing whole blood control of seven trace elements (magnesium,manganese,iron,copper,zinc,lead,calcium) in laboratory and evaluate its performance.Methods Heparin sodium anticoagulant calf whole blood was used as substrateMetal salt or standard solution with target concentration of each element was added.And whole blood control product was made after process of anticorrosion,mixing and sub-packaging.Antibacterial effect was observed,uniformity and stabilitywasevaluatedaccording to CNAS-GL03 and matrix effects was evaluatedaccording to CLSI EP14.SDI (standard deviation index) and detection coefficient of variation (CV)were calculated to evaluateapplication effectiveness.Results Laboratory preparation of whole blood control reached target concentration,sterility tests was qualified,results of uniformity and stability indicated that the substrate was even and stable at least for one year.Besides,matrix effects of other six elements can be ignored except lead.Historical and inter-laboratory comparisons had shown that laboratory preparation of whole blood control has no obvious difference with commercial ones in performance.Conclusion The formulation and evaluation scheme of whole blood control of seven trace elements (magnesium,manganese,iron,copper,zinc,lead,calcium) was feasible and can be used as commercial ones for elementary tests in medical laboratory.
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Objective To explore the clinical significance of human papillomavirus L1 capsid protein detection in cervical exfoliated cells in high-risk HPV positive women. Methods From November 2012 to June 2013,386 high-risk HPV positive (detected by hybrid capture Ⅱ) cases were enrolled as eligible women from Huzhou Maternity&Child Care Hospital and Women′s Hospital,School of Medicine, Zhejiang University. All eligible women underwent liquid-based cytology (ThinPrep) followed by colposcopy. Biopsies were taken if indicated. Cervical exfoliated cells were collected for HPV L1 capsid protein detection by immunocytochemistry. Expression of HPV L1 capsid protein in groups with different histological diagnosis were compared, and the role of HPV L1 capsid protein detection in cervical exfoliated cells in cervical lesions screening was accessed. Results Total 386 enrolled eligible women were finally diagnosed histologically as follwed:162 normal cervix, 94 low-grade squamous intraepithelial lesion (LSIL), 128 high-grade squamous intraepithelial lesion (HSIL) and 2 squamous cervical cancer (SCC). The positive expression rate of HPV L1 in HSIL+(HSIL or worse) group was significantly lower than that in LSIL-(LSIL or better) group (19.2% vs 66.4%,P=0.000). While identifying HSIL+ in HPV positive cases and compared with cytology, HPV L1 detection resulted in significant higher sensitivity (80.77%vs 50.77%,P=0.000) and negative predictive value (NPV;87.18% vs 76.47%,P=0.004), significant lower specificity (66.41% vs 81.25%,P=0.000),and comparable positive predictive value (PPV;54.97% vs 57.89%, P=0.619). To identify HSIL+in HPV-positive/cytology-negative women, the sensitivity, specificity, PPV, and NPV of HPV L1 detection were 87.50%, 61.54%, 41.18%, and 94.12%respectively, while 80.00%, 86.36%, 80.00%and 86.36%respectively in HPV-positive/atypical squamous cell of undetermined significance(ASCUS)women. Conclusions HPV L1 capsid detection in cervical exfoliated cells have a role in cervical lesions screening in high-risk HPV positive women, and may be a promising triage for high-risk HPV-positive/cytology-negative or ASCUS women.