The device used to detect the presence of heterophile antibodies in a blood sample, which are indicative of an Infectious Mononucleosis (Mono) Infection, typically caused by the Epstein-Barr virus (EBV); this is usually done through a rapid test format, commonly known as a “Monospot” test, utilizing techniques like latex agglutination to visualize the antibody-antigen reaction when positive.

Intended Use of Infectious Mononucleosis Immunological Test System

An Infectious Mononucleosis Immunological Test System is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.

Intended Use:

Intended for the qualitative detection of Infectious Mononucleosis Heterophile Antibodies in serum, plasma, or whole blood as an aid in the diagnosis of infectious mononucleosis.

Device Description:

The test uses colour immunochromatographic dipstick technology with bovine erythrocyte extract coated on the membrane. The sample is mixed with the diluent, and the Test Stick is placed in the mixture. If a specific IM heterophile antibody is present, it forms a complex with the conjugated colour particles. The complex is bound by immobilized bovine erythrocyte extract, indicating a positive result.

PERFORMANCE TESTING (Analytical-Non-clinical) for Infectious Mononucleosis Immunological Test System

• stability Studies
• Precision/Reproducibility
• Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
• Linearity/assay reportable range
• Traceability (controls, calibrators, or method)
• Retrospective Study
• Analytical Sensitivity
• Analytical Specificity (Cross Reactivity)
• Interfering Substances
• Prozone effect study

Clinical Testing:

No Guidance available for 510k submission