POC test for chlamydia and gonorrhea equivalent to lab-based assay

NEW YORK (Reuters Health) -A new 30-minute point-of-care (POC) test using self-collected vaginal swabs works similarly to a lab-based molecular diagnostic test to detect chlamydia and gonorrhea, revealing new findings. It has been.

The test could improve the screening and treatment of these sexually transmitted diseases (STIs), which has been increasing in the United States since 2013, Dr. Barbara Van Der Pol of the University of Alabama at Birmingham Medical School told Reuters. It was Phone health.

“In conclusion, chlamydia and gonorrhea are still the most frequently reported notifiable diseases in the United States, costing $ 5 to $ 6 billion to manage the effects of untreated infections,” she says. Stated. “Unfortunately, about 70% of infected women are asymptomatic and don’t know they need to be tested.

The Centers for Disease Control and Prevention guidelines recommend that women under the age of 25, men having sex with men, and people using pre-HIV prophylaxis be screened annually for chlamydia and gonorrhea. But they also add, “At least half of women in the age group who have an encounter with the healthcare system are not screened according to CDC guidelines.”

The authors say that patients who are tested for chlamydia or gonorrhea often have to wait several days for results to become more widespread and may develop pelvic inflammatory disease. There is. As a result, many clinics and hospitals treat patients based on epidemiological predictions.

In a new study, Dr. Van Der Pol and her team presented swab samples of 1,523 women (53.6% with symptoms) and 922 men (33.4% symptom) to 11 clinics in nine cities in the United States. Sex) urine samples were analyzed. From three commercial nucleic acid amplification assays (NAAT) using the binx io chlamydia / gonorrhea assay from binx health that funded the study.

In women, there were 129 Chlamydia infections (8.5%) and 45 cases of gonorrhea (3.0%). The POC test correctly identified 124 cases of Chlamydia (96.1%) and all 45 gonorrhea infections (100%).

The authors estimated a specificity of 99.1% for chlamydia and 99.9% for gonorrhea. The positive predictive value was 90.5% for chlamydia, 95.7% for gonorrhea, and the negative predictive values ​​were 99.6% and 100%, respectively.

Among men, there were 120 Chlamydia infections (13.0%) and 74 Neisseria gonorrhoeae infections (8.0%). Sensitivity was 92.5% for Chlamydia, 97.3% for Chlamydia, and specificities were 99.3% and 100%, respectively. The positive predictive value was 94.9% for chlamydia and 100% for gonorrhea, while the negative predictive value was 98.9% and 99.8%, respectively.

Men’s POC tests were less sensitive than other lab-based tests, with a sensitivity of at least 99%.

The test took only 30 minutes, so the patient could collect the swabs when they arrived at the doctor’s office, with results in time for the clinician to prescribe treatment at the same visit.

“We need to do a better job of introducing testing and screening into primary care,” she added. “We can’t rely on STD’s professional services, because it doesn’t help us get out of this problem.”

In an email to Reuters Health, Dr. Emma Hardingesch, an associate professor at the London Hygiene and Tropical University in the UK who is studying STI’s new diagnostic technology, said: “In addition to having a wider public health impact, this 30-minute test can change patient care.”

This works like a traditional lab test for a female vaginal swab, so “this means the test can replace the conventional lab test. This uses CT / CT to POCT. Reducing the overprescription of antibiotics for patients who test negative on NG but are otherwise symptomatically treated may further help combat antibiotic resistance. ”

“The performance of the female vaginal swab test is excellent, but the data on male urine show that more work is needed,” added Dr Harding Esch, who was not involved in the study. “In addition, test performance is not the only factor to consider when deciding to use a new diagnostic test. Other considerations include the feasibility of clinical path adaptation, stakeholder awareness, and, of course, cost. It is included.”

Dr. Van der Paul and several co-authors report an economic link to binx health.

Source: bit.ly/3bKLFjT JAMA Network Open, online, May 14, 2020.