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The MeMed BV test is an automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatic serum and venous whole blood samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. MeMed BV is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for less than seven days. The MeMed BV test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

The MeMed BV® ("BV test" or the "test") is an In-Vitro-Diagnostic device that measures in parallel the blood concentrations of TRAIL, IP-10 and CRP. The test consists of an automated analyzer with built-in hardware and software that conduct chemiluminescence based analyte measurements of patient serum and venous whole blood samples and their computational integration (MeMed Key®), and a disposable cartridge that contains the reagents and controls needed to detect the analytes of interest (MeMed BV® cartridge). The test generates an answer to each sample, with a test run time of approximately 15 minutes.

The MeMed BV test is an automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The MeMed BV is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for less than seven days. The MeMed BV test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

The Med BV® ("BV Test" or the "Test") is an In-Vitro-Diagnostic device that measures in parallel the blood concentrations of TRAIL, IP-10 and CRP. The Test consists of an automated analyzer with built-in hardware and software that conduct chemiluminescencebased analyte measurements of patient serum samples and their computational integration (MeMed Key®), and a disposable cartridge that contains the reagents and controls needed to detect the analytes of interest (MeMed BV® cartridge). The Test generates an answer to each sample, with a test run time of approximately 15 minutes.

The DiaSorin LIAISON® MeMed BV® is an automated in vitro diagnostic semi-quantitative assay that uses chemiluminescent immunoassay (CLIA) technology to measure three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The LIAISON® MeMed BV® assay is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for seven days or less. The LIAISON® MeMed BV® assay generates a numeric score that falls within discrete interpretation ranges based on the increasing likelihood of bacterial infection. The assay has to be performed on the automated LIAISON® XL Analyzer. The DiaSorin LIAISON® MeMed BV® Control Set is intended for use as assayed quality control to monitor the performance of the DiaSorin LIAISON® MeMed BV® assay. The performance characteristics of the LIAISON® controls have not been established for any other assays or instrument platforms different from the automated LIAISON® XL Analyzer. The control set is intended for in vitro diagnostic use in a professional laboratory only.

The LIAISON MeMed BV assay consists of three individual chemiluminescence immunoassay (CLIA) for quantitative determination of TRAIL, IP-10, and CRP. The LIAISON MeMed BV test result is a score between 0 and 100 derived from computational integration of the measurements of the three proteins TRAIL, IP-10, and CRP, where low scores are indicative of viral infection and high score of bacterial infection. All three reagent packs must be the same lot and present at the same time on the same instrument used for sample testing. All three reagent packs are individually calibrated and quality controlled. Specimens are to be assigned to the MMBV assay protocol where all three reagent packs will be utilized to provide combined results and a final score. The TRAIL reagent pack uses a monoclonal antibody for capture of TRAIL and a polyclonal antibody for the detection of TRAIL. The assay incubates sample, calibrator or control with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the TRAL. Following the incubation, an isoluminol conjugated polyconal antibody that recognizes TRAIL is then added to the reaction and incubated. The unbound conjugate is removed with a wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of TRAL present in the calibrators, controls or samples. The result of the TRAIL reagent pack is only used to calculate a final LIAISON MeMed BV Score and should not be used individually for diagnosis. The IP-10 reagent pack uses a monoclonal antibody for the capture of IP-10 and a polyclonal antibody for the detection of IP-10. The assay incubates sample, calibrator or control with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the IP-10. Following the incubation, an isoluminol conjugated polyclonal antibody that recognizes IP-10 is then added to the reaction and incubated. The unbound conjugate is removed with a wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of IP-10 present in the calibrators, controls or samples. The result of the IP-10 reagent pack is only used to calculate a final LIAISON MeMed BV Score and should not be used individually for diagnosis. The CRP reagent pack uses monoclonal antibodies for capture and detection of CRP. First the patient serum sample is pre-diluted 1:196 with assay buffer. The assay incubates the pre-diluted sample, calibrator or control with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the CRP. Following the incubation, an isoluminol conjugated monoclonal antibody that recognizes CRP is then added to the reaction and incubated. The unbound conjugate is removed with a wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of CRP present in the calibrators, controls or samples. The result of the CRP reagent pack is only used to calculate a final LIAISON MeMed BV Score and should not be used individually for diagnosis.

The MeMed BV™ test is an automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. MeMed BV™ is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for less than seven days. The MeMed BV™ test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

The MeMed BV™ ("BV test" or the "test") is an In-Vitro-Diagnostic device that measures in parallel the blood concentrations of TRAIL, IP-10 and CRP. The test consists of an automated analyzer with built-in hardware and software that conduct chemiluminescence-based analyte measurements of patient serum samples and their computational integration (MeMed Key™), and a disposable cartridge that contains the reagents and controls needed to detect the analytes of interest (MeMed BV™ cartridge). The test generates an answer to each sample, with a test run time of approximately 15 minutes.