- A rapid, point-of-care infectious disease immunoassay designed for the qualitative detection of Infectious Mononucleosis heterophile antibodies, which are produced by the immune system in response to an Epstein-Barr virus (EBV) infection
Uses
- Infectious Mononucleosis Screening:
- Aids clinicians in the rapid differential diagnosis of glandular fever/mono in patients exhibiting clinical signs like fever, sore throat, swollen lymph nodes, and extreme fatigue
- On-Site Patient Testing:
- Used directly within primary care practices, pediatric facilities, college health clinics, and urgent care environments
- Flexible Matrix Diagnostics:
- Accommodates multiple sample types, allowing testing to be performed using human whole blood, serum, or plasma specimens
Features
- Flexible CLIA Complexity:
- Earns CLIA Waived status when utilizing whole blood specimens, enabling standard medical staff to legally run the test without a complex laboratory setup
- High Diagnostic Accuracy:
- Features an exceptional accuracy profile with >99% clinical sensitivity and 96% specificity
- No Age Limitations:
- Unlike some competitive assays that struggle with younger populations, this test is clinically validated for patients of all ages, including young pediatric cases
- Comprehensive 25-Stick Layout:
- Ships ready-to-use with 25 test sticks, 25 test tubes, 25 transfer pipettes, 25 capillary pipettes, sample buffer diluent, and standalone positive/negative liquid controls
- "QC Inside®" Quality Insurance:
- Packaged with 2 additional test sticks strictly designated for external quality control testing, totaling 27 sticks in the box
Benefits
- Accelerated Actionable Results:
- Delivers highly clear, reliable visual data in 5 minutes, allowing clinicians to confirm or rule out mono before the patient leaves the clinic
- Error-Free Interpretation:
- Uses an easy-to-read, two-color line system to visually confirm results clearly and remove staff reading subjectivity
- Room-Temperature Stability:
- Requires only standard room-temperature storage, freeing up critical healthcare refrigerator space
