An Infectious Mononucleosis (IM) Immunological Test System is a diagnostic system used to detect heterophile antibodies or Epstein-Barr virus (EBV) antibodies in human serum or plasma. It is primarily used to diagnose infectious mononucleosis, which is commonly caused by EBV.

Intended use

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:

The device is an in vitro diagnostic Immunological Test System intended for the qualitative detection of heterophile antibodies associated with Infectious Mononucleosis in human serum, plasma, or whole blood specimens. Detection of these heterophile antibodies aids in the diagnosis of Infectious Mononucleosis in patients who present with clinical signs and symptoms such as fever, sore throat, and lymphadenopathy. Results are intended to be used in conjunction with clinical evaluation and other laboratory findings to support the diagnosis of infectious mononucleosis.

Device Description

The Test uses color immunochromatographic dipstick technology with bovine erythrocyte extract coated on the membrane. In the test procedure, serum, plasma or whole blood is mixed with the Diluent. Then the Test Stick is placed in the mixture and the mixture migrates along the membrane. If the specific IM heterophile antibody is present in the sample, it will form a complex with the bovine erythrocyte extract conjugated color particles. The complex will then be bound by bovine erythrocyte extract immobilized on the membrane and a visible blue Test Line will appear to indicate a positive result.

Key Components

• Test device or strip — Typically a disposable membrane or card-based unit impregnated with antigens (e.g., extracted erythrocyte antigens) that bind heterophile antibodies if present in the specimen.
• Sample collection materials — May include lancets, sample tubes, capillary pipettes, or droppers for applying whole blood, serum, or plasma to the test.
• Buffer reagents — For facilitating migration of specimen and enhancing antigen–antibody interaction.
• Controls — Some kits include external positive and negative controls to verify assay performance.

Performance testing (Analytical — Non-clinical) performance testing for Infectious Mononucleosis (IM) Immunological Test System

• Principle/Design Verification (kit/component verification)

Verify each kit component (membrane, conjugate, buffer, sample pad, card/cassette) performs to specification (flow rate, reagent deposition, control line function).

• Cut-off / Visual Read Criteria and Limit of Detection (where applicable)
• Precision / Reproducibility (within-run and between-run / between-operator / between-lot)- as per CLSI EP12-A2
• Matrix Equivalence / Specimen Type Comparison
• Interference / Analytical Specificity
• Cross-reactivity / Analytical Specificity to Non-target Antibodies
• Hook Effect / Prozone
• Stability — Shelf-life and Open-vial / In-use Stability.
• Lot-to-Lot Consistency / Manufacturing Variability
• Environmental / Transport Conditions
• Analytical Sensitivity / Specificity (method comparison vs predicate/reference method).
• Usability / Human Factors (if intended for POC / non-lab personnel)

Clinical testing

No Guidance available for 510k submission