Patients reporting to the outpatient departments of peripheral health care settings in India with symptoms of
urinary tract infection (UTI) receive one or the other
antibiotic before culture confirmation and out of the total culture confirmed UTI cases, in less than one third cases the prescribed
antibiotics matches to the
antibiotic sensitivity test result. Hence, in this study, an indigenous point-of-care (POCT) rapid diagnostic kit (Rapidogram) for UTI was validated against conventional urine culture and sensitivity to understand its possible applicability at peripheral health care settings. This cross-sectional study was conducted during November 2021 to June 2022 in OPDs of two peripheral hospitals. A sample size of 300 was calculated using prevalence of
urinary tract infection (UTI) as 33% for sensitivity and specificity using Buderer's formula. Urine specimens were collected following standard aseptic procedures from the recruited suspected UTI cases and transferred to laboratory maintaining the cold chain. The validation work up was done in two sections: lab validation and field validation. Out of 300 urine samples, 29 were found positive for the growth of UTI pathogen by both methods and 267 were found negative by both methods. Thus, the kit shows very high specificity (99.6%; 97.9-99.9%) and considerably high sensitivity (90.6%; 74.9-98.0%). We also observed higher PPV, NPV, test accuracy (> 96%). Diagnostic Odds Ratio and Youden index were respectively 2581 and 0.89. Clinical data showed that 44% of the suspected UTI cases were prescribed at least one
antibiotic before urine test. Mostly they received
Norfloxacin whereas the mostly identified organism E.coli was sensitive to
Nitrofurantoin. In the context of absence of microbiology facility at peripheral setting and rampant empirical use of
antibiotics in UTI, this highly specific and sensitive POCT for UTI may be used as it not only identifies the organism, also shows the
antibiotic sensitivity pattern.