The Mono Rapid Test is a lateral flow immunoassay for the qualitative detection of heterophile antibodies specific to Infectious Mononucleosis (IM) in human plasma and serum specimens. The test is intended for use as an aid in the diagnosis of IM in patients with characteristic clinical symptoms.  The test is intended for professional use only

Specification:
Specimen: Whole blood/serum/plasma

Relative Sensitivity: 98.6% (146/148)*

Relative Specificity: 98.8 % (255/258)*

Overall Agreement: 98.8 % (401/406)*

Packaging: 25 cards/box, 
Certificate:  ISO 13485
Raw materials is imported from US
OEM packaging is available

Accuracy

The accuracy of the Mono Rapid Test was evaluated in comparison to a commercially available qualitative color immunochromatographic assay for the detection of IM IgM heterophile antibodies in human serum, plasma or whole blood. Four hundred and six (406) human serum, plasma and whole blood samples (288 serum, 103 plasma and 15 whole blood) were used in the comparison study. The comparison results are summarized in Table 2.

Table

Certificate: CE and ISO 13485