| Background and PurposeAt present, according to the state food and drug administration (CFDA) website statistics, China domestic detection reagent of vaginal disease up to 21, the test items include pH, hydrogen peroxide (H2O2), leukocyte esterase (LET), saliva acid glycosides (SNA), proline aminopeptidase (PIP), acetyl amino glycosidase enzymes (NAG), beta glucuronic acid enzyme, coagulase, polyamine (PA), lactic acid and oxidase. In view of the existing detection reagent variety, project, but whether or not it has diagnostic value on all kinds of vaginal disease, reagents consistency between the case, we will have four clinical vaginal secretions samples commonly used reagent comparative analysis on the market of this kind of reagent to determine the clinical diagnostic value.Subjects and MethodsAccording to the need to collect bacterial vaginitis, trichomonas vaginitis, mould sex vaginitis, mycoplasma vaginitis and normal crowd five kinds of the sample, we collected 2014 to May 2015, our hospital outpatient specimen of 389 cases of vaginal secretion. Amsel criteria method is used as the gold standard for diagnosis of bacterial vaginosis (BV), mycoplasma positive cultivation, trichomonad and candida culture positive for clinical diagnosis of mycoplasma vaginitis, trichomonas vaginitis, and the gold standard for candida vaginitis. BV specimens collected 122 cases,80 cases of mycoplasma vaginitis, trichomonas vaginitis,72 cases,102 cases of candida vaginitis; For 96 cases of normal cases. The specimens of 389 cases, respectively, at the same time four vaginitis reagent (A, B, C, D), four types of vaginitis detection reagent test pH, hydrogen peroxide (H2O2), leukocyte esterase (LET), saliva acid glycosides enzyme (SNA), proline aminopeptidase (PIP), acetyl amino glycosidase enzymes (NAG), beta glucuronic acid enzyme, coagulation.Through comparative analysis of four kinds of reagents of the test items of four kinds of vaginitis disease sensitivity, specific degrees, the misdiagnosis rate, missed diagnosis, the total coincidence rate and youden index to evaluate the diagnostic value of each reagent. At the same time by paired sample T test to compare three reagents for PH value detection of consistency; Kappa test to as a detecting reagent between the same project between the consistency check.ResultsFour for the diagnosis of bacterial vaginal disease detection reagent sialic acid glycosides enzyme (SNA) degree of sensitivity, specific and youden index of reagents respectively A:47.5%,97.4% and 97.4%; Reagent B:75.4%,35.6% and 35.6%; Reagent C:73.8%,81.3% and 55.1%; Reagent D:68.9%,95.5% and 95.5%; Average of 72.7%, 70.8% and 43.5%. Three detection reagent proline aminopeptidase (PIP) degree of sensitivity, specific and youden index of reagents respectively B:30.4%,86.6% and 86.6%; Reagent C:21.3%,100.0% and 21.3%; Reagent D:2.5%,100.0% and 2.5%, the average was 18.1%,95.5%and 13.6%Three kinds of mould sex to the diagnosis of vaginal disease detection reagent proline aminopeptidase (PIP) degree of sensitivity, specific and youden index of reagents respectively B:16.7%,81.2% and 2.1%; Reagent C:6.9%,93.4% and 0.3%; Reagent D:1.0%,100.0% and 1.0%, the average was 8.2%,91.5% and 0.3%. Acetyl amino glycosidase enzymes (NAG) degree of sensitivity, specific and youden index of reagents respectively B:69.6%,59.9% and 59.9%; Reagent C:62.7%,44.6% and 7.3%; Reagent D:46.1%,68.3% and 46.1%, the average was 59.5%,57.6% and 17.1%.For diagnosis of trichomonas vaginitis three detection reagent acetyl amino glycosidase enzymes (NAG) degree of sensitivity, specific and youden index of reagents respectively B:63.9%,36.9% and 36.9%; Reagent C:83.3%,48.6% and 31.9%; Reagent D:73.6%,73.2% and 73.6%, the average was 73.6%,52.9% and 26.5%.Reagent between different testing consistency check of the project. Three reagents (B, C, D) for the determination of PH have significant difference (P< 0.05). Test items between each H2O2 reagent Kappa value is kathi Jones from A&B respectively 0.066, &c 0.028,0.028,0.052, A&D B&C B&D, C&D 0.1810.113. Detection project LET Kappa value between each reagent is kathi Jones from A&B respectively 0.073,&c 0.083,0.083,0.048, A&D B&C B&D, C&D 0.208 0.225. Between each test project SNA reagent Kappa value is kathi Jones from A&B respectively 0.128,&c 0.071,0.062, A&D B&C 0.051 and 0.051,0.016, C&D B&D P< 0.05). Between each test NAG reagent Kappa B&C, B&D 0.072 and 0.098, respectiely, in C&D 0.259. Between each test PIP reagent Kappa B&C, B&D 0.004 and 0.248, respectiely, in C&D 0.004. Test items of coagulase kathi Jones from A&B Kappa value was 0.000, respectively.Conclusion1) SNA detection project for bacterial vaginosis diagnosis value is relative taller, the average youden index were greater than other test items.2) Each detection reagent consistency between all kinds of projects are poor (in addition to the reagents C&D SNA), Kappa value was< 0.4.3) This study found that the diagnostic value of vaginal disease all kinds of testing reagent is not high, and the diagnostic value of each reagent is uneven. |
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