Field Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection.

BACKGROUND: The 2013-2016 West African Ebola virus disease (EVD) epidemic is the largest recorded. Triage on the basis of clinical signs had limited success, and the time to diagnosis by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) could exceed 5 days. Here we describe the development and field validation of the ReEBOV Antigen Rapid Test (ReEBOV RDT) to aid triage of individuals with suspected EVD. METHODS: Samples from patients with suspected EVD were submitted to Kenema Government Hospital, Sierra Leone, for Lassa fever and EVD screening throughout 2014. Banked residual clinical samples were tested in November 2014 and January 2015 in a blinded field trial to estimate the clinical effectiveness of the ReEBOV RDT, compared with EBOV-specific qRT-PCR. RESULTS: Preliminary ReEBOV RDT performance demonstrated a positive percentage agreement (PPA) of 91.1% (195 of 214 results; 95% confidence interval [CI], 86.5%-94.6%) and a negative percentage agreement (NPA) of 90.2% (175 of 194; 95% CI, 85.1%-94.0%). The final estimates used by the Food and Drug Administration to determine whether to grant emergency use authorization for the test, which excluded a qRT-PCR reference method threshold cutoff, were a PPA of 62.1% (72 of 116 results; 95% CI, 52.6%-70.9%) and a NPA of 96.7% (58 of 60; 95% CI, 88.5%-99.6%), with a diagnostic likelihood of 18.6. A subsequent, independent evaluation by the World Health Organization generated results consistent with the preliminary performance estimates. CONCLUSIONS: The ReEBOV RDT demonstrated the potential to provide clinically effective rapid and accurate point-of-care test results and, thus, to be a powerful tool for increasing triage efficiency.

Analysis of pharmacist charges for medication therapy management services in an outpatient setting.

PURPOSE: Pharmacist charges for medication therapy management (MTM) services in an outpatient setting were analyzed. METHODS: Patients' visits with pharmacists in three ambulatory care clinics in a large, urban teaching institution from December 2005 through February 2006 were analyzed. Data collected included the number and type of current diseases, insurance coverage, number of medications patients were taking, pharmacist time spent per patient visit, pharmacy services provided, and estimated charge for services based on level of care provided using physician and pharmacist billing codes. Data were analyzed using descriptive statistics. RESULTS: A total of 500 pharmacist-patient visits were evaluated. The mean +/- S.D. patient age was 59.0 +/- 13.3 years. Patients had a mean +/- S.D. of 4.0 +/- 2.0 diseases and were taking 9.1 +/- 4.6 medications. The majority of visits (83%) lasted 30 minutes or less. The mean charge per visit using incident-to physician care billing was $37.09 and $63.24 for level 1 and level 2 visits, respectively. Pharmacist billing was found to result in an average charge of $26.58 ($1 per minute), $53.16 ($2 per minute), or $79.72 ($3 per minute) per visit. There was no difference in pharmacist time spent with complex patients versus noncomplex patients ( p = 0.1314). The use of pharmacist billing codes would not be beneficial unless each visit was billed as $3 per minute. CONCLUSION: Converting from incident-to physician billing to pharmacist billing would not generate additional revenue for this medical center at this time.