Publicado en May 21, 2020, 2 p.m.
The FDA granted 510(k) clearance to binx io for a women’s health molecular rapid point of care diagnostic testing platform for detecting chlamydia and gonorrhea in about a half hour in August 2019.
Image courtesy of binx at https://mybinxhealth.com/clinician-solutions/
The technology platform is a rapid and fully automated test that requires no calibration, no maintenance, and no additional steps are required once the single use assay specific cartridge is loaded into the machine. This is intended for use at point of care or at clinical laboratory settings using female vaginal swab samples that can be collected by a clinician or self collected by the patient in a clinical setting.
Clearance was granted based on a multicentre trial that included 17 evaluation centers involving over 1500 symptomatic and asymptomatic patients. The accuracy and reliability of binx io was compared with the current lab standard of care systems for detection of chlamydia and gonorrhea in this study. Results demonstrated that the system was comparable to central lab testing showing a 96.1% sensitivity with a 99.1% specificity for chlamydia, and 100% sensitivity with 99.9% specificity for gonorrhea testing among the women tested in the study, according to the company.
Jeff Luber, President and CEO of binx health said, “With the ‘front door’ of healthcare increasingly moving to near-patient settings, today’s FDA clearance puts the power of rapid onsite care where consumers need it most—in the communities where they live, work and shop.”
Binx is working to revolutionize STI diagnostics with a collection of technology solutions to improve the patient and clinician experience. The company is hoping to tackle the STI epidemic with these convenient, discrete and efficient testing options to eliminate some of the barriers which will hopefully help to stop the spread of infection through at home testing and point of care testing with an internet connection system that puts clinicians in control for ordering, viewing local population data, and making strategic decisions regarding reaching the untested members of the community.
Chlamydial and gonococcal rates of infection continue to increase in America, as do the costs of untreated infections. Improved diagnostics that support testing and treatment within a single clinical visit are key to advancing efforts to control the rates of infection.
A recent study published in JAMA Network on May, 14, 2020 evaluated the performance of this point of care platform for the detection of chlamydia and gonorrhea with commercially available laboratory based molecular diagnostics. This study included 1523 women with a median age of 27 and 922 men with a median age of 29.
Findings from this cross sectional study found the system was associated with excellent performance when compared with laboratory based molecular diagnostics for vaginal swabs, and male urine samples were associated with good performance in the assay which is undergoing continued evaluation.
This rapid point of care testing can support same day single visit testing and treatment strategies based on these findings: For chlamydia the sensitivity of the assay was 96.1% for woman with a specificity of 99.9%; and sensitivity was 92.5% for men with a specificity of 99.3%. For gonorrhea the sensitivity was 100% for women with a specificity of 99.9% and sensitivity was 97.4% for men with a specificity of 94.8%.
Findings suggest that self obtained vaginal swab samples were associated with performance equivalent to lab based molecular diagnostics and support the use of this POC assay in many settings. Availability of accurate results in about a half hour has the potential to increase the power to facilitate testing and treatment within a single patient visit to test for chlamydia and gonorrhea in point of care testing in clinical settings and in non-clinical venues.
Future research can assess how such testing can be used to improve clinic flow to free up time and help to control spread of disease. Most people are willing to wait this short period of time to get their results, reducing the need for a return visit. In American only about 50% of women are screened, having an easy to use quick test readily available could help to make a step forward to ensure that women’s sexual health needs are being met.
"Our experience testing the binx io system revealed a potentially major paradigm shift in the process of addressing STIs," said Dr. Barbara Van Der Pol, president of the American STD Association, director of a diagnostic lab at the University of Alabama at Birmingham School of Medicine. "During a recent evaluation, we found that a high proportion of patients were willing to wait when presented with the possibility of rapid results, suggesting that test-and-treat in the same visit is possible for the first time."
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