高危型人乳头瘤病毒核酸(分型)检测试剂的临床应用初步评价

Preliminary evaluation on clinical application of high-risk human papillomavirus DNA (genotype) diagnostic kit

目的通过对正常人群样本、宫颈癌样本的检测,评估市售实时荧光定量PCR方法学高危型HPV分型检测试剂临床应用性能。方法分别采用两种荧光PCR检测试剂(A试剂与B试剂)对1 000例的体检样本、48例宫颈鳞癌样本和18例宫颈腺癌样本进行HPV DNA检测并对比其结果,评价其临床应用性能。结果 A试剂与B试剂检测体检样本阳性率分别为18.5%和16.5%。14种HPV型别阳性一致性百分比为97.57%,阴性一致性百分比为98.78%,总一致性百分比为98.58%。A试剂与B试剂检测48例宫颈鳞癌样本阳性率分别为100%和95.83%,其中HPV16型(66.7%)、58型(14.6%)、18型(10.4%)所占比例较高。18例宫颈腺癌样本阳性率分别为83.33%和77.78%,HPV16型(50%)、18型(27.7%)和51型(11.1%)所占比例较高。通过比较发现A试剂在宫颈鳞癌和腺癌样本中的阳性检出率较B试剂高。结论通过检测对比,两种试剂一致性较好,而A试剂检测下限更低,检测性能更好,更适用于人群宫颈病变的早期检测与筛查,具有较高的临床应用价值。

Objective To evaluate the clinical application performance of marketed commercial high-risk human papillomavirus(HPV)DNA(genotype)diagnostic kits based on real-time fluorescent quantitative PCR method by testing normal population samples and cervical cancer samples.Methods Two kinds of HPV diagnostic kits(reagents A and B)based on fluorescent quantitative PCR were separately used to detect HPV DNA in 1,000 physical examination samples,48 cervical squamous cell carcinoma samples and 18 cervical adenocarcinoma samples,the results were compared and the clinical application performances of the two reagents were evaluated.Results The positive rates of the physical examination samples detected by reagents A and B were 18.5%and 16.5%respectively.The positive,negative and total coincidence rates of 14 kinds of HPV genotypes were 97.57%,98.78%and 98.58%respectively.The positive rates of 48 cervical squamous cell carcinoma tissue samples detected by reagents A and B were 100%and 95.83%respectively,of which HPV types 16(66.7%),58(14.6%)and 18(10.4%)accounted for a higher proportion.The positive rates of 18 cervical adenocarcinoma tissue samples detected by reagents A and B were 83.33%and 77.78%respectively,of which HPV types 16(50%),18(27.7%)and 51(11.1%)accounted for a higher proportion.The comparison results revealed that the positive rates of cervical squamous cell carcinoma and adenocarcinoma tissue samples detected by reagent A were higher than those detected by reagent B.Conclusions A comparison of the detection results indicates that the two reagents are in good consistency.Reagent A shows a lower detection limit and better detection performance,it is more suitable for the early detection and screening of cervical lesions in population,with high clinical application value.