Product Manual

Page 9 of 77QuickVue+ Infectious Mononucleosis test

FOR INFORMATIONAL USE ONLY

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FOR INFORMATIONAL USE ONLY

Not to be used for performing assay. Refer to most current package insert accompanying your test kit.

LIMItAtIOns

1. As is the case of any other diagnostic procedure, the results obtained by this kit yield

data that must be used in addition to other information available to the physician.

2. QuickVue+ Infectious Mononucleosis test is a qualitative test for the detection of IM

heterophile antibodies.

3. A negative result may be obtained from patients at the onset of the disease due to

antibody concentration below the sensitivity of this test kit. If symptoms persist or

increase in intensity, the test should be repeated.

4. Some segments of the population who contract Infectious Mononucleosis do not

produce measurable levels of heterophile antibodies. Approximately 50% of children

under 4 years of age who have IM may test as IM heterophile antibody negative.

PeRFORMAnCe CHARACteRIstICs

QuickVue+ Infectious Mononucleosis test was compared to two other commercially

available test kits: an EIA, and a slide hemagglutination test. The results obtained using

QuickVue+ Infectious Mononucleosis test were substantially equivalent to the results

obtained using these other tests and are summarized below.

Table 1: In this study, a total of 511 serum, plasma and whole blood samples were tested

using QuickVue+ Infectious Mononucleosis test and a commercially available EIA.

Of the 511 samples, 74 were found to be positive by EIA and also positive by the

QuickVue+ Infectious Mononucleosis test; similarly, 437 were found to be negative by

EIA and 436 were also negative by the QuickVue+ Infectious Mononucleosis test.

Based on this data, speciﬁcity was 99.8% (436/437), and sensitivity was >99.9% (74/74).

Overall agreement was 99.8% (510/511).

QuickVue+ IM Positive

QuickVue+ IM Negative

TOTAL

EIA

Positive

EIA

Negative

436

437