دراسة مقارنة بين اختبار الامتزاز المناعي باستخدام تفاعلات السلسلة المتبلمرة و الفحوصات الروتينية لمرضى الجهاز البولي التناسلي في محافظتي كربلاء و بابل.

A comparative study between immunochromatographic strip by using PCR assay and routine diagnostic assay of urogenital patients in Karbala and Babylon governorates

The study was beginning from November 2022 to end of June of 2023; participants were enrolled in the study. After taking a patient’s history and performing a physical examination, clinicians swabbed to collect three specimens. One of these specimen was immediately placed in a plastic tube with phosphate buffer saline and sodium azide for determine the Trichomonas vaginalis (T. vaginalis) or Candida albicans (C. albicans) present by using immunochromatographic strip, also another swab was immediately inoculate in NaOH and HCl solution for determined Neisseria gonorrhea (N. gonorrhea) by using immunochromatographic strip. The remaining of specimen that used in immunochromatographic strip used for Polymerase Chain Reaction (PCR) assay and microscopic examination. Sometimes the clinicians take additional swab for culturing C. albicans and N. gonorrhea.
A cross-sectional investigation was conducted, and a total of 285 patients (146 males and 139 females) distributed as 271single isolation and 14 mixed isolation from patients older than 18 years (18-59) of age who presented with signs and symptoms of vaginitis, urethritis, prostatitis and pelvic inflammatory disease were enrolled in the study. In order to determine three microorganisms responsible for urogenital disease which include T. vaginalis, N. gonorrhea and C. albicans.
The study found 144 (50.52%) positive specimens of urogenital patients included 130 (90.27%) cases single isolation and 14(9.73%) cases mixed isolation, where 43 (15.08%) for T. vaginalis, 20 (7.02%) for N. gonorrhea and 81 (28.42%) for C. albicans. The remaining 141 (49.48%) negative strips may be due to other causative agents. Females had 11.93%, 2.11%, and 20.7% of T. vaginalis, N. gonorrhea, and C. albicans infections respectively in clinical specimen. Males had 3.15%, 4.91% and 7.72%, for T. vaginalis, N. gonorrhea and C. albicans respectively. There is a clear significant difference in microorganisms that transmitted by urogenital system for both sexes (X2=16.74, P=0.0002), with T. vaginalis and C. albicans having the highest infection rates in females and N. gonorrhea in males.
The site of isolation plays a major role in the presence of microorganisms (X2=80.94, P =0.001), as the vagina in females recorded more infection than other sites for both T. vaginalis and C. albicans; it was recorded as 18 (12.5%) of T. vaginalis and 52 (36.11%) C. albicans specimen, while N. gonorrhea found more prevalence in urethral of males which recorded 14(9.72%).
The results of the present study, when comparing the sensitivity and specificity of both PCR and Immunochromatography strip for detection of T. vaginalis, introduce that the value of sensitivity was 87.23% and specificity was 97.93%, while for N. gonorrhea presented that the value of sensitivity was 41.67%, and specificity 95.37% as well as C. albicans, presented that the value of sensitivity was 91.76%, and specificity was 94.91%.
The conclusion include the new immunochromatography strip have sensitivity and specificity more than routine diagnostic tests for T. vaginalis N. gonorrhea, and C. albicans, also Immunochromatographic strips given the results within few minutes in compare to microscopic and culture.