News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Rapid, RNA Probe-Based Multiplex Assay Can Help Doctors More Accurately Diagnose Vaginitis

New models for integrated healthcare, such as medical homes and accountable care organizations (ACO), are moving from concept to reality. This will create different ways for clinical pathology laboratories to add value to patient care.

One important attribute of these new integrated healthcare delivery vehicles is the greater emphasis given to primary care. Health policymakers want primary care physicians, OB/GYNs, and pediatricians to be more proactive in detecting and treating disease while encouraging the patient to more actively maintain optimal health.

This photo shows the small-footprint automated analyzer used as part of the multiplex RNA probe-based assay used to improve the time to answer and accuracy of diagnosing vaginitis.

This photo shows the small-footprint automated analyzer used as part of the multiplex RNA probe-based assay used to improve the time to answer and accuracy of diagnosing vaginitis.

Studies of the pilot demonstration projects of medical homes and ACOs have determined that physicians practicing in such settings are motivated to better utilize clinical laboratory tests. These doctors understand the importance of ordering the right medical laboratory test at the right time. They also are more open to consultations with pathologists, Ph.D.s, and the other types of clinical laboratory scientists who are experts in laboratory medicine.

Successful Clinical Pathology Laboratory Tests Meet Three Criteria

For its part, to better serve an integrated care environment like a medical home, the clinical laboratory profession needs diagnostic tests which can deliver three primary benefits:

First, such medical laboratory tests give the physician a more accurate diagnosis, particularly when compared to the existing standard of care. It is important that, upon receiving these test results, the physician has therapeutic choices for treating the patient. The objective is to run a diagnostic test that can be followed up by treatment that is beneficial to the patient.

Second, the clinical laboratory must be able to perform the test and produce accurate results in a consistent and economical manner. The key here is that the expense of producing the accurate diagnostic answer is cost-effective for the medical laboratory.

Third, when performing this diagnostic test, the laboratory must be adequately reimbursed, whether by fee-for-service or other payment method.

Such a conjunction of benefits does not happen often. One clear winner was the emergence of HIV viral load and mutation testing in the second half of the 1990s. This panel of clinical laboratory testing informed the physician about the effectiveness of the expensive multiple-drug regimen that was helping the patient control the disease.

Because the HIV patient’s drug cocktail could cost as much as $2,000 per month, the healthcare system considered the several hundred dollars it cost to perform the viral load and mutation testing to be money well-spent. That’s because the results of the medical laboratory testing is used by the physician to adjust the mix of therapeutic drugs in ways that continued to suppress the measurable amount of HIV in the patient. It also helped the patient avoid taking an expensive therapeutic drug that had ceased to be of benefit.

Pathologists Watching for New Clinical Laboratory Test Technologies

For all the reasons above, pathologists and clinical laboratory managers are always on the look-out for new assays and new testing technologies which, when introduced into clinical use, deliver high clinical value to the referring physician and his/her patient, are economical to run in the medical laboratory, and are reimbursed adequately.

One new molecular diagnostics test that has caught the attention of several early-adopter clinical laboratories is an RNA probe-based automated multiplex assay that can accurately detect all three causative agents for vaginitis, which are Candida species, Gardnerella vaginalis, and Trichomonas vaginalis. The assay takes less than 45 minutes and uses a single specimen.

The potential demand for this multiplex molecular assay is significant. More than 10 million obstetrician-gynecologist office visits each year are attributed to vulvovaginitis.  Further, since multiple specimens were previously required for a physician to render the correct diagnosis, introduction of this new single new multiplex molecular assay is more patient-friendly.

Reimbursement guidelines for this type of testing are well-established. The test is considered “medically necessary” for patients with symptoms of vaginitis and is reimbursed under CPT codes 87480 (Candida), 87510 (Gardnerella) and 87660 (Trichomonas).

This multiplex molecular assay is made and distributed by Becton, Dickinson and Company. It is sold under the name “BD Affirm™ VPIII Microbial Identification Test.” The manufacturer says that this clinical laboratory test is “significantly more sensitive” than microscopy, and comparable to culture for Candida, scored Gram stain for Gardnerella and Diamond’s culture for Trichomonas.

Dark Daily has published a White Paper on this topic. It is titled “Vaginitis Diagnosis: An Opportunity to Improve Patient Care”. It is written by an award-winning author known for her work in communicating complex scientific advances to clinical and business communities, and was edited by a clinical microbiologist in the Department of Pathology, Ochsner Healthcare System, who was formerly the Director of the Clinical Microbiology Laboratory and Associate Professor of Pathology at the Louisiana State University Health Science Center in Shreveport, LA.

The introduction into clinical practice of a rapid, RNA probe-based multiplex assay that can aid the physician in more accurately diagnosing a condition like vaginitis, demonstrates how newer molecular diagnostics and genetic testing technologies can advance clinical care—while contributing to an overall reduction in the cost per healthcare episode.

This combination of increased diagnostic accuracy, accompanied by improved patient outcomes and a measurable reduction in the overall cost of care, strikes to the sweet spot of laboratory medicine. It also shows how new molecular and genetic test technologies can be expected to support new care protocols while advance the value delivered by clinical laboratories and anatomic pathology groups.

Related Information:

Vaginitis Diagnosis: An Opportunity to Improve Patient Care

BD Affirm™ VPIII Microbial Identification Test

Diagnostic Testing for STIs and Vaginitis