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Kits for the diagnosis of infectious mononucleosis compared with the Paul-Bunnell test
A Uldall1, B S Jensen, J Henrichsen
1Department of Clinical Chemistry, University of Copenhagen, Herlev Hospital, Denmark.
Abstract:
We compared the results obtained with six different test kits for infectious mononucleosis with those obtained with the Paul-Bunnell test. The investigation was carried out in one laboratory using 149 selected pools of patient sera. Each pool was tested three times with the Paul-Bunnell test and once with each kit. The results obtained with the kits were grouped according to the titre found with the Paul-Bunnell test. The percentage of positive results within each group was calculated for each kit. The Paul-Bunnell titre, which would have classified 50% of the specimens as positive, was estimated for each kit and this was designated the 50% cut off value. In general, there was good agreement. However, false positive test results were found rather frequently with one kit (19%) and the 50% cut off values differed. One kit showed a 50% cut off value at about 8, another at about 16, and the rest at between 16 and 32. We suggest the introduction of improved internal quality control combined with external quality assessment.
Insights
Six infectious mononucleosis test kits were compared to the Paul-Bunnell test. Results showed good agreement, but one kit had frequent false positives, and 50% cutoff values varied significantly.
Area of Science:
- Clinical diagnostics
- Immunology
- Infectious diseases
Background:
- Infectious mononucleosis diagnosis relies on serological tests.
- The Paul-Bunnell test is a standard reference, but newer kits offer potential advantages.
- Evaluating the performance of commercially available diagnostic kits is crucial for accurate clinical decisions.
Purpose of the Study:
- To compare the diagnostic performance of six infectious mononucleosis test kits against the established Paul-Bunnell test.
- To assess the agreement and identify discrepancies between different diagnostic methodologies.
- To determine the 50% cutoff values for each kit relative to the Paul-Bunnell test.
Main Methods:
- A single laboratory conducted the study using 149 selected patient serum pools.
- Each serum pool was tested thrice with the Paul-Bunnell test and once with each of the six evaluated kits.
- Results were analyzed by grouping according to Paul-Bunnell titre and calculating the percentage of positive results for each kit.
Main Results:
- Overall, good agreement was observed between the kits and the Paul-Bunnell test.
- One kit exhibited a high rate of false positives (19%).
- The estimated 50% cutoff values varied, ranging from approximately 8 to between 16 and 32, indicating differences in kit sensitivity.
Conclusions:
- While most kits showed good agreement, variations in performance and cutoff values necessitate careful selection.
- The high false positive rate in one kit highlights the need for improved diagnostic accuracy.
- Recommendations include implementing enhanced internal quality control and external quality assessment for infectious mononucleosis testing.