Sexually transmitted diseases · 2026
A rapid molecular test for gonorrhea and chlamydia compared to Gram stain for symptomatic patients in a specialized STI clinic: a randomized controlled trial.
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Jarolimova Jana, Kong Daniel, Sanders Gabriela, Shah Palak, Psaros Christina, Parker Robert A, Ard Kevin L, Bassett Ingrid V, STI Rapid Testing Research Group (Nancy H Nicholson, CNP 1, Robert P Ober, FNP 1, Vitor G Cardoso, CNP 1, Diane G Kanjilal, CNP 1, Emily L Perriello, CNP 1, Daniel P Worrall, CNP 8)
Аннотация
BACKGROUND: Molecular point-of-care testing (POCT) for sexually transmitted infections (STIs) may decrease antibiotic use, time to treatment, and loss to follow-up. However, the real-world impact of molecular POCTs on clinical management and outcomes in STI clinics is unknown.
METHODS: We conducted a randomized controlled trial to evaluate the impact of a 30-minute, PCR-based test for gonorrhea and chlamydia among symptomatic patients in an STI clinic. Patients ≥18y with urethritis or cervicitis were randomized 1:1 to standard of care (SOC; point-of-care Gram stain) or PCR-based urogenital gonorrhea and chlamydia testing using the binx io (PCR). Primary outcome was antibiotic days of therapy (DOT); secondary outcomes included diagnosis-concordant antibiotic use and process measures. Focus group discussions with clinic providers explored implementation.
RESULTS: We enrolled 49 participants per arm; median age 29.5y (IQR 25-39), 63.3% male. Overall, 16 (16.3%) tested positive for gonorrhea, 7 (7.1%) for chlamydia. In the PCR arm, 39/49 (79.6%) waited to receive results. There was a trend towards fewer antibiotic DOT in the PCR arm (median 1 [IQR 0-7] vs 7 [0-8], p=0.053). At time of clinic visit, 10% more SOC participants unnecessarily received gonorrhea-active antibiotics. Median visit time was 57 minutes [45-69] for SOC and 87 [72-97] for PCR. Providers valued results-directed treatment, however, PCR testing disrupted clinic workflows.
CONCLUSIONS: A PCR-based POCT for gonorrhea and chlamydia non-significantly decreased antibiotic DOT and overuse in this small study. PCR STI POCTs may improve diagnosis-concordant antibiotic use for symptomatic patients in STI clinics, however, clinic workflows will need to adapt.Trial registration: NCT05564299.
METHODS: We conducted a randomized controlled trial to evaluate the impact of a 30-minute, PCR-based test for gonorrhea and chlamydia among symptomatic patients in an STI clinic. Patients ≥18y with urethritis or cervicitis were randomized 1:1 to standard of care (SOC; point-of-care Gram stain) or PCR-based urogenital gonorrhea and chlamydia testing using the binx io (PCR). Primary outcome was antibiotic days of therapy (DOT); secondary outcomes included diagnosis-concordant antibiotic use and process measures. Focus group discussions with clinic providers explored implementation.
RESULTS: We enrolled 49 participants per arm; median age 29.5y (IQR 25-39), 63.3% male. Overall, 16 (16.3%) tested positive for gonorrhea, 7 (7.1%) for chlamydia. In the PCR arm, 39/49 (79.6%) waited to receive results. There was a trend towards fewer antibiotic DOT in the PCR arm (median 1 [IQR 0-7] vs 7 [0-8], p=0.053). At time of clinic visit, 10% more SOC participants unnecessarily received gonorrhea-active antibiotics. Median visit time was 57 minutes [45-69] for SOC and 87 [72-97] for PCR. Providers valued results-directed treatment, however, PCR testing disrupted clinic workflows.
CONCLUSIONS: A PCR-based POCT for gonorrhea and chlamydia non-significantly decreased antibiotic DOT and overuse in this small study. PCR STI POCTs may improve diagnosis-concordant antibiotic use for symptomatic patients in STI clinics, however, clinic workflows will need to adapt.Trial registration: NCT05564299.