Immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, or plasma. Status Mono test qualitatively detects infectious mononucleosis antibodies in human whole blood, serum, or plasma specimens. This test is intended for use as an aid in the diagnosis of infectious mononucleosis.
Product Specifications
| Sample type | Whole blood, serum, or plasma specimen collection |
| Time to results | 8 minutes |
| With controls | Sensitivity 99.9% / Specificity 98.8% |
| Whole blood only | Sensitivity 99.9% / Specificity 98.3% |
| Kit contents | Test devices, Developer solution, Negative control, Positive control, Package insert, Procedure card, (10 µL) (black line) sample transfer pipettes for use with serum/plasma, (25µL) (red line) sample transfer pipettes for use with whole blood |
| Storage | 35-86°F (2-30°C) |
| CLIA complexity | Waived |
| Certification | FDA |
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