Specialty testing with ease.
Discover the benefits of the full assay menu for the VIDAS® 3 immunoassay analyzer.
Just Announced!
VIDAS® TBI (GFAP, UCH-L1)
ASSAY OVERVIEW
What is it?
This test assists in determining the need for a CT scan in adult patients presenting within 12 hours of injury with suspicion of mild traumatic brain injury (mTBI).
Key Points
- High sensitivity (96.7%); High NPV (99.5%)
- Objective, accurate answer for mTBI management
- Helps clinicians perform fast, efficient triage of patients with confidence
- Optimizing CT scan usage and improving patient care
How does it work?
The test detects the blood-based biomarkers GFAP, UCH-L1, which are released after a brain injury has occurred. A negative interpretation of VIDAS TBI (GFAP, UCH-L1) is associated with the absence of acute intracranial lesions visualized on a head CT scan.
Time to Result: ~39 Minutes
ASSAY OVERVIEW
What is it?
A test to aid in the risk assessment for moderate to severe acute kidney injury (AKI).
Key Points
- Aids in the early risk assessment of AKI by identifying kidney stress before damage occurs.1-4
- Enhances patient management to both prevent AKI and promptly address the condition if it arises.1-4
How does it work?
The test determines the presence of the proteins TIMP-2 and IGFBP-7 in human urine. These proteins are cellular markers of renal tubule cell-cycle arrest, which indicates kidney stress.5
Time to Result: ~46 Minutes
ASSAY OVERVIEW
What is it?
A multifaceted test with applications in sepsis, lower respiratory tract infections (LRTI), and antibiotic decision-making.
Key Points
- Aids in the risk assessment for progression to severe sepsis or septic shock in critically ill patients on their first day of intensive care unit (ICU) admission.9
- Aids in assessing the cumulative 28-day risk of all-cause mortality in patients diagnosed with severe sepsis or septic shock, in patients pending ICU admission, using a change in PCT level over time.9
- Aids in decision-making on antibiotic therapy for patients with suspected or confirmed LRTI in the emergency department (ED) or inpatient setting.9
- Aids in the decision-making on antibiotic discontinuation in patients with suspected or confirmed sepsis.9
How does it work?
Procalcitonin, a peptide precursor to the hormone calcitonin, exhibits minimal levels under normal homeostatic conditions. Bacterial infections trigger an increase in PCT, whereas viral infections inhibit its production. Successful treatment typically leads to a reduction in systemic inflammation, resulting in a decline in procalcitonin levels.9
Time to Result: ~20 Minutes
ASSAY OVERVIEW
What is it?
A test that rules out the diagnosis of pulmonary embolism (PE) or deep vein thrombosis (DVT) in low- and moderate-risk outpatients suspected of PE or DVT.
Key Points
- To be used in conjunction with a clinical pretest probability assessment model.11-13
- Studies show that ED patients with a normal (500 ng/ml) VIDAS® D-DIMER EXCLUSION™ II result and a low or moderate PTP (pre-test probability) score can be excluded from further testing.11-13
How does it work?
This test operates by detecting fibrin degradation product (FDP) D-dimer, a byproduct of clot formation. Although clots are typically beneficial, they can occasionally form without bleeding, leading to serious or life-threatening complications. Due to the high sensitivity and negative predictive value of this test, a negative result assists clinicians in ruling out DVT and PE in select patients.13
Time to Result: ~20 Minutes
ASSAY OVERVIEW
VIDAS® MEASLES IgG, VIDAS® MUMPS IgG, VIDAS® RUBELLA IgG, and VIDAS® VARICELLA IgG
What are they?
These are tests that assess the immune status for the viral pathogens measles, mumps, rubella, and varicella.
Key Points
- Robust menu for occupation health screening.
- Understand the immune status for highly transmissible diseases.
How do they work?
The tests identify the presence of IgG antibodies, aiding in the determination of immunity status specific to the pathogen.
Time to Result: ~35-40 Minutes
ASSAY OVERVIEW
What are they?
Screening tests that aid in the diagnosis of Lyme disease.
Key Points
- Facilitate classification of Lyme borreliosis: early or late/chronic, active or immune14
- Low level of cross-reaction (syphilis, other infectious diseases)14
- No equivocal zone for VIDAS® LYME IgG II results14
-
A two-test approach to diagnosis14:
- Initial screening by antibody testing
- If positive or equivocal, follow-up testing by Western blot
How do they work?
These tests distinguish acute from later-stage or historical exposure to Lyme disease by providing separate results for the presence of IgM and IgG antibodies to borrelia burgdorferi.14
Time to Result: ~27 Minutes
ASSAY OVERVIEW
What is it?
These tests identify C. difficile, which causes infectious diarrhea and is highly transmissible. Help prevent transmission, control outbreaks, and provide the appropriate antimicrobial treatment to the patient.
Key Points
Aids in the diagnosis of Clostridium difficile in symptomatic patients through a two-step testing process, providing informative insights to guide treatment decisions.16
How does it work?
The antigen glutamate dehydrogenase (GDH), acts as an initial screening tool for suspected C. difficile infections. The detection of either toxin A or toxin B supports the presence of a true pathogenic infection.16
Time to Result:
~50 Minutes GDH
~75 Minutes TOXIN A/B
ASSAY OVERVIEW
What is it?
This assay aids in the diagnosis of Helicobacter pylori infections.
Key Points
- Early diagnosis assists in clinical intervention to prevent bleeding or development of gastric cancer.
- Test is non-invasive, inexpensive, and quick and easy to perform compared to alternative methods.19
How does it work?
A qualitative test detects the presence of anti-H. pylori IgG antibodies.19
Time to Result: ~35 Minutes
ASSAY OVERVIEW
VIDAS® TOXO IgM, VIDAS® TOXO IgG, VIDAS® CMV IgM, VIDAS® CMV IgG
What are they?
These tests help to determine a woman's immune status of toxoplasmosis (TOXO) or cytomegalovirus (CMV).
Key Points
Identifying toxoplasmosis and human cytomegalovirus infection in expectant mothers is crucial for evaluating the potential risks of serious infections, as well as neurological and developmental disabilities in the fetus.21-23
How do they work?
These qualitative and quantitative serum tests detect the presence of the antibodies lgG (past infection) and lgM (active infection) for each respective pathogen. IgM is commonly linked to acute, active infections, while IgG is indicative of subacute or past infections with resolved immune cell antigen recognition.21
Time to Result:
~40 Minutes TOXO
~60 Minutes CMV
ASSAY OVERVIEW
What is it?
This test aids in the early detection and confirmation of pregnancy by detecting the presence of human chorionic gonadotropin (HCG).
Key Points
Pregnancy tests for females of reproductive age are often performed routinely in emergency department (ED) evaluations. Reasons for frequent testing range from the potential morbidity and mortality of treating or misdiagnosing a pregnant patient to medicolegal concerns.25
How does it work?
This quantitative test is designed to detect the presence of human chorionic gonadotropin (hCG), which is widely used in the early detection and confirmation of pregnancy.26
Time to Result: ~30 Minutes
Complete Assay Menu
ACUTE KIDNEY INJURY
VIDAS® NEPHROCHECK®
What is it?
A test to aid in the risk assessment for moderate to severe acute kidney injury (AKI).
How does it work?
The test determines the presence of the proteins TIMP-2 and IGFBP-7 in human urine. These proteins are cellular markers of renal tubule cell-cycle arrest, which indicates kidney stress.5
SEPSIS
VIDAS® B▪R▪A▪H▪M▪S PCT™
What is it?
A multifaceted test with applications in sepsis, lower respiratory tract infections (LRTI), and antibiotic decision-making.
How does it work?
Procalcitonin, a peptide precursor to the hormone calcitonin, exhibits minimal levels under normal homeostatic conditions. Bacterial infections trigger an increase in PCT, whereas viral infections inhibit its production. Successful treatment typically leads to a reduction in systemic inflammation, resulting in a decline in procalcitonin levels.9
BLOOD CLOTS
VIDAS® D-DIMER EXCLUSION™ II
What is it?
A test that rules out the diagnosis of pulmonary embolism (PE) or deep vein thrombosis (DVT) in low- and moderate-risk outpatients suspected of PE or DVT.
How does it work?
This test operates by detecting fibrin degradation product (FDP) D-dimer, a byproduct of clot formation. Although clots are typically beneficial, they can occasionally form without bleeding, leading to serious or life-threatening complications. Due to the high sensitivity and negative predictive value of this test, a negative result assists clinicians in ruling out DVT and PE in select patients.13
OCCUPATIONAL HEALTH ASSAYS
VIDAS® MEASLES IgG, VIDAS® MUMPS IgG, VIDAS® RUBELLA IgG, and VIDAS® VARICELLA IgG
What are they?
These are tests that assess the immune status for the viral pathogens measles, mumps, rubella, and varicella.
How do they work?
The tests identify the presence of IgG antibodies, aiding in the determination of immunity status specific to the pathogen.
LYME DISEASE
VIDAS® LYME IgM II, VIDAS® LYME IgG II
What are they?
Screening tests that aid in the diagnosis of Lyme disease.
How do they work?
These tests distinguish acute from later-stage or historical exposure to Lyme disease by providing separate results for the presence of IgM and IgG antibodies to borrelia burgdorferi.14
GASTROINTESTINAL
VIDAS® C. difficile GDH, VIDAS® C. difficile TOXIN A&B (CDAB)
What is it?
These tests identify C. difficile, which causes infectious diarrhea and is highly transmissible. Help prevent transmission, control outbreaks, and provide the appropriate antimicrobial treatment to the patient.
How does it work?
The antigen glutamate dehydrogenase (GDH), acts as an initial screening tool for suspected C. difficile infections. The detection of either toxin A or toxin B supports the presence of a true pathogenic infection.16
GASTROINTESTINAL
VIDAS® H. pylori
What is it?
This assay aids in the diagnosis of Helicobacter pylori infections.
How does it work?
A qualitative test detects the presence of anti-H. pylori IgG antibodies.19
PRENATAL CARE ASSAYS
VIDAS® TOXO IgM, VIDAS® TOXO IgG, VIDAS® CMV IgM, VIDAS® CMV IgG
What are they?
These tests help to determine a woman's immune status of toxoplasmosis (TOXO) or cytomegalovirus (CMV).
How do they work?
These qualitative and quantitative serum tests detect the presence of the antibodies IgG (past infection) and IgM (active infection) for each respective pathogen. IgM is commonly linked to acute, active infections, while IgG is indicative of subacute or past infections with resolved immune cell antigen recognition.21
PRENATAL CARE
VIDAS® HCG
What is it?
This test aids in the early detection and confirmation of pregnancy by detecting the presence of human chorionic gonadotropin (HCG).
How does it work?
This quantitative test is designed to detect the presence of human chorionic gonadotropin (hCG), which is widely used in the early detection and confirmation of pregnancy.26
TRAUMATIC BRAIN INJURY
VIDAS® TBI (GFAP, UCH-L1)
What is it?
This test assists in determining the need for a CT scan in adult patients presenting within 12 hours of injury with suspicion of mild traumatic brain injury (mTBI).
How does it work?
The test detects the blood-based biomarkers GFAP, UCH-L1, which are released after a brain injury has occurred. A negative interpretation of VIDAS TBI (GFAP, UCH-L1) is associated with the absence of acute intracranial lesions visualized on a head CT scan.
Discover the benefits of our full immunoassay menu.
Make the most of your VIDAS® 3 immunoassay system. Reach out to sales now if you'd like to learn more about our comprehensive portfolio of immunoassay solutions.
References
- Kashani K, Al-Khafaji A, Ardiles T, et al. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013; 17:R25.
- Meersch M, Volmering S, Zarbock A. Prevention of acute kidney injury. Best Pract Res Clin Anaesthesiol. 2017 Sep;31(3):361-370. doi: 10.1016/j.bpa.2017.08.002. Epub 2017 Aug 18. PMID: 29248143.
- KDIGO. Kidney Inter, Suppl. 2012;2:1-138.
- Bihorac A. Nephron. 2015; 131(2): 118-122. doi:10.1159/000439387 9.
- VIDAS Nephrocheck Package Insert, No. rev. 057209-02-2023-en
- Dasta JF, Kane-Gill SL, Durtschi AJ, et al. Costs and outcomes of acute kidney injury (AKI) following cardiac surgery. Nephrol Dial Transplant. 2008;23(6):1970-1974.
- Doyle JF, Forni LG, Acute kidney injury: short-term and long-term effects. Crit Care. 2016;20:188
- Hoste EAJ, Bagshaw SM, Bellomo R, et al. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015;41(8):1411–1423.
- VIDAS BRAHMS PCT Package Insert, No. rev. 044579-04-en-2022-11
- Elixhauser A, Friedman B, Stranges E. Septicemia in U.S. hospitals, 2009: statistical brief #122. Healthcare cost and utilization project (HCUP) statistical briefs. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011.
- Perrier A, Desmarais S, Miron MJ, et al. Non-invasive diagnosis of venous thromboembolism in outpatients. Lancet 1999; 353:190-195.
- Perrier A, Roy PM, Aujesky D, et al. Diagnosing Pulmonary Embolism in Outpatients with Clinical Assessment, D-Dimer Measurement, Venous Ultrasound, and Helical Computed Tomography: A Multicenter Management Study. Am J Med. 2004;116(5):291-299.
- VIDAS D-DIMER Exclusion Package Insert, No. Rev. 054222-01 - en - 2019-10
- VIDAS Lyme IgM Package Insert, No. rev. 050275-en-2019-09, Lyme IgG Package Insert, No 047656-02-en-2019-09
- Molins CR, Delorey MJ, Replogle A, Sexton C, Schriefer ME. Evaluation of bioMérieux's dissociated VIDAS Lyme IgM IITM (LYM) and IgG IITM (LYG) as a first-tier 6 diagnostic assay for Lyme disease. J Clin Microbiol. 2017;55(6):1698-1706. dio: 10.1128/JCM.02407-16.
- VIDAS C. difficile GDH Package Insert, No. rev. 0466i48-03-en-2019-08
- McDonald LC, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018.
- Ticehurst JR, Aird DZ, Dam LM, Borek AP, Hargrove JT, Carroll KC. Effective detection of toxigenic Clostridium difficile by a two-step algorithm including tests for antigen and cytotoxin. J Clin Microbiol. 2006;44(3):1145-1149.
- VIDAS H. pylori IgG Package Insert, No. rev.045314-02-en-2019-08
- Lacy BE, Rosemore J. Helicobacter pylori: ulcers and more: the beginning of an era. J Nutr. 2001;131:2789S–93S.PubMedExternal LinkGoogle ScholarExternal Link
- VIDAS Toxo IgG Package Insert, No. rev. 13687 E-en-2019/03.
- VIDAS Toxo IGM Package Insert, No. rev. 13699 F-en-2018/06.
- VIDAS CMV IgG Package Insert No. rev. 046638-03-en-2022-11. VIDAS CMV IgM Package Insert, No. rev. 046640-04-en-2019011
- Toxoplasmosis | Boston Children's Hospital. (n.d.). https://www.childrenshospital.org/conditions/toxoplasmosis#:~:text=However%2C%20by%20the%20third%20trimester,been%20exposed%20to%20the%20parasite.
- Strote, J. (2006). Patient self assessment of pregnancy status in the emergency department. Emergency Medicine Journal, 23(7), 554–557. https://doi.org/10.1136/emj.2005.031146
- VIDAS HCG Package Insert, No. rev. 052011-02-en-2019-09
- Korley, F.K., et al., Emergency Department Evaluation of Traumatic Brain Injury in the United States, 2009-2010. J Head Trauma Rehabil, 2016. 31(6): p. 379-387.