FAQ

MeMed BV and MeMed Key are FDA, CE-IVD and AMAR cleared and available in the US, EU, and Israel.

The MeMed BV^® from serum test requires 100 µL collected using a Serum Separator Tube (SST) from a venous blood draw. MeMed BV from whole blood* test requires 150µl collected using EDTA (lavender top) tube from a venous blood draw.

*MeMed BV on venous whole blood is 510K cleared. Currently available only for the US market.

US: 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 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.

*MeMed BV on venous whole blood is 510K cleared. Currently available only for the US market.

EU and Israel: The MeMed BV test is an automated semi-quantitative immunoassay for professional clinical use only that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples. The Test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The Test is indicated for use in patients presenting to the emergency department, urgent care center and inpatients with suspected acute bacterial or viral infection. 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 test is intended for in vitro diagnostic use only.

US: The test is indicated for patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients who have exhibited symptoms of acute infectious disease for less than or equal to 7 days and experienced fever within the last 7 days.

The overall prevalence of bacterial infection in a given population may affect assay interpretation.

The test has not been studied in patients under 90 days old, and patients with one or more of the following conditions:

• Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis;
• Active inflammatory disease;
• Congenital or acquired immune deficiency;
• Chronic fungal or parasitic infection;
• Infection with human immunodeficiency virus (HIV);
• Hepatitis B virus (HBV);
• Hepatitis C virus (HCV);
• Infection with active tuberculosis (TB);
• Significant trauma or burns in the last 7 days;
• Patients that have undergone major surgery in the last 7 days.
• Pregnant women
• Active malignancy
• Whole blood only – patients with hematocrit levels under 30% or over 50%

The test is not intended as a standalone diagnostic test, is not intended to identify specific pathogens or predict disease course and is not intended to distinguish between infectious and non-infectious etiologies.

EU & Israel: The test is indicated for hospital admitted patients, and patients presenting to the emergency department, urgent care center who have exhibited symptoms of acute infectious disease for less than 7 days and experienced fever within the last 7 days.

The overall prevalence of bacterial infection in a given population may affect assay interpretation.

The test has not been studied in patients under 90 days old, and patients with one or more of the following conditions:

• Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis;
• Active inflammatory disease;
• Congenital or acquired immune deficiency;
• Chronic fungal or parasitic infection;
• Infection with human immunodeficiency virus (HIV);
• Hepatitis B virus (HBV);
• Hepatitis C virus (HCV);
• Infection with active tuberculosis (TB);
• Significant trauma or burns in the last 7 days;
• Patients that have undergone major surgery in the last 7 days.
• Pregnant women
• Active malignancy

The test is not intended as a standalone diagnostic test, is not intended to identify specific pathogens or predict disease course and is not intended to distinguish between infectious and non-infectious etiologies.

MeMed compared the performance of the MeMed BV test in distinguishing bacterial from viral infection to that of commonly used clinical and laboratory parameters. Each parameter was measured solely and in combinations: best performing pair (ANC and Lymph %), triplet (ANC, Lymph % and Pulse), and quadruplets (ANC, Lymph %, Pulse, Mono %).¹

Of the multiple comparisons, the MeMed BV test performed significantly better (P<10^-15).

1. Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, et al. A novel host-proteome signature for distinguishing between acute bacterial and viral infections. PloS One. 2015 Mar 18;10(3):e0120012.

MeMed BV has not been studied in patients under 90 days old.

MeMed BV is indicated for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infections.  By providing a rapid, accurate result based on the host response to determine likelihood of bacterial or viral infection, MeMed BV helps physicians to make faster, more informed diagnostic decisions.

Procalcitonin (PCT) is an amino acid precursor of calcitonin and can be applied to aid in differential diagnosis decisions for patients with lower-respiratory tract infections (LRTI) in an inpatient setting or Emergency Department and on antibiotic discontinuation for patients with sepsis.

Figure from Oral Presentation at ACEP 2021 by Richard Rothman, MD PhD. These data are the findings of a sub-analysis of the Apollo Study (NCT04690569; data on file). The sub-analysis focused on patients presenting to the emergency department, n = 290. TPR, true positive rate; FPR, false positive rate.

MeMed BV has several advantages over PCT:

• MeMed BV compares favorably on determining bacterial versus viral infection (see Figure)
• Multiple studies establish MeMed BV’s diagnostic accuracy not only in adults but, unlike PCT.^1-5
• MeMed BV’s intended use is applicable for patients with suspected bacterial or viral infection and not restricted to only patients with LRTI or sepsis like PCT
• MeMed BV is cleared for use not only in the emergency department and during patient admission but, unlike PCT, also at urgent care centers

1. Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, et al. A novel host-proteome signature for distinguishing between acute bacterial and viral infections. PloS One. 2015 Mar 18;10(3):e0120012.
2. Ashkenazi-Hoffnung L, Oved K, Navon R, Friedman T, Boico O, Paz M, et al. A host-protein signature is superior to other biomarkers for differentiating between bacterial and viral disease in patients with respiratory infection and fever without source: A prospective observational study. Eur J Clin Microbiol Infect Dis. 2018 Jul;37(7):1361-71.
3. Stein M, Lipman-Arens S, Oved K, Cohen A, Bamberger E, Navon R, et al. A novel host-protein assay outperforms routine parameters for distinguishing between bacterial and viral lower respiratory tract infections. Diagn Microbiol Infect Dis. 2018 Mar 1;90(3):206-13.
4. Mor M, Paz M, Amir L, Levy I, Scheuerman O, Livni G, et al. Bacterial vs viral etiology of fever: A prospective study of a host score for supporting etiologic accuracy of emergency department physicians. PLoS One. 2023 Jan 30;18(1):e0281018.
5. Papan C, Argentiero A, Porwoll M, Hakim U, Farinelli E, Testa I, et al. A host signature based on TRAIL, IP-10, and CRP for reducing antibiotic overuse in children by differentiating bacterial from viral infections: A prospective, multicentre cohort study. Clin Microbiol Infect. 2022 May 1;28(5):723-30.

MeMed BV is pathogen agnostic, in that it detects our immune response to the pathogen and does not detect the pathogen itself. The performance of MeMed BV in differentiating between bacterial and viral infection has been validated in multiple prospective, multi-center, double blinded, independent studies and real-world clinical use on thousands of patients with reproducible results. The studies included patients infected with many different bacterial or viral pathogens, and multiple strains, supporting that MeMed BV should also perform well for emerging pathogens.

MeMed BV is intended for use in patients who have had symptoms of acute infection for up to 7 days, with one of the symptoms being fever.
The performance of MeMed BV in differentiating between bacterial and viral infection in such patients has been established irrespective of time from symptom onset.^1-3

1. Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, et al. A novel host-proteome signature for distinguishing between acute bacterial and viral infections. PloS one. 2015 Mar 18;10(3):e0120012.
   https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0120012
2. van Houten CB, de Groot JA, Klein A, Srugo I, Chistyakov I, de Waal W, et al. A host-protein based assay to differentiate between bacterial and viral infections in preschool children (OPPORTUNITY): A double-blind, multicentre, validation study. Lancet Infect Dis. 2017 Apr 1;17(4):431-40.
   https://pubmed.ncbi.nlm.nih.gov/28012942/
3. Papan C, Argentiero A, Porwoll M, Hakim U, Farinelli E, Testa I, et al. A host signature based on TRAIL, IP-10, and CRP for reducing antibiotic overuse in children by differentiating bacterial from viral infections: A prospective, multicentre cohort study. Clin Microbiol Infect. 2022 May 1;28(5):723-30. https://www.sciencedirect.com/science/article/pii/S1198743X21006212

In many cases, it is not possible to detect a pathogen using a respiratory pathogen panel. This can be because the pathogen is inaccessible (for example, located in the lower respiratory tract) or not targeted by the pathogen-specific panel (for example, an emerging strain). In addition, pathogen detection is intrinsically constrained in that detection does not necessarily equate with symptoms causation (e.g. colonizers).

One added value of MeMed BV is that the test does not require access to the pathogen, as it is based on immune proteins that circulate in the blood. Another added value of MeMed BV is that it interprets our immune response to the pathogen, and so the test result is not affected by non-invasive colonizers that do not trigger our immune system.

Pathogens detected by various technologies (e.g., culture, or rapid PCR) may be merely “bystanders” (colonizers) and not the underlying cause of a patient’s current illness. Examples include:

Throat Culture: A positive Group A Streptococcus culture (GAS) confirms the presence of GAS, but it is unable to differentiate between colonization and the etiology of the acute illness.

PCR: The detection of a viral respiratory pathogen by PCR does not exclude the possibility of bacterial co-infection.

An added value of MeMed BV is that the result can help the physician decide if the detected pathogen is likely the clinically relevant pathogen that is causing the illness.

MeMed BV provides a bacterial score when there is a bacterial-induced host immune response.

This may occur in either of the following circumstances:

• Sole bacterial infection
• Concomitant viral and bacterial infections

Multiple studies have shown that MeMed BV accurately distinguishes between sole viral and viral/bacterial co-infection helping physicians to make faster, more informed diagnostic decisions.

The MeMed BV score bin reflects the likelihood of a bacterial or viral infection and scores are not correlated with severity.

The MeMed BV score is robust across all stages of the infection for patients who have exhibited symptoms of acute infectious disease for less than or equal to 7 days and experienced fever within the last 7 days.

Our Applications team can be on-site to help with multiple aspects of implementation, including but not limited to: training multiple shifts, assisting in the analytical verification process, go-live support, and more.

Relevant materials for both lab and clinicians including product IFUs, MeMed Key Quick Guide, custom clinical educational events & tools, protocol guidance, and more. Ask your Applications team for more information.

Yes, MeMed BV^® test (PLA code 0351U) is $260.50, effective Jan 1, 2023 on the CLFS.

Reimbursement coverage will vary depending on the payer and type of reimbursement. Please refer to your billing specialists or specific payer.