Specificity and Sensitivity: underexposed?

EpiCheck @Home Urine Collection Kit

August 6, 2020

Importance of NPV, Specificity and Sensitivity in biomarker urine tests in bladder cancer.

Biomarker urine tests such as the Bladder EpiCheck can be a valuable addition to urological practice. Biomarker urine tests can lead to a decrease in the number of (unnecessary) cystoscopies, the number of hospital visits and thus contribute to the QOL for the patient. To achieve that, a biomarker urine test must of course do exactly what you and your patient expect it to do. A reduction in the number of unnecessary cystoscopies with a very low risk of missing disease. Therefore choose the Bladder EpiCheck. The bladder cancer follow-up biomarker urine test with the highest sensitivity and specificity (and NPV!).

Bladder cancer biomarkers are often only assessed for their NPV (negative predictive value). Obviously, having a high NPV is important. However, the question of how this NPV came about is often a question (or explanation) that is skipped. The NPV alone says nothing in itself about how good a test is.

For example, a follow-up study in which the chance of disease is very low: 2.5%. Everyone in this studied population (2.5% incidence of disease) gets a negative result. The NPV is then 97.5%. The test obviously scores poorly because everyone with illness is missed. Still, there is a "beautiful" NPV to show. The NPV alone does not tell the whole story and can therefore be confusing or even misleading.

A high sensitivity and a high specificity are therefore also very important to make the right choice. A high sensitivity gives a low chance of false negatives and therefore of missing (high-grade) disease. High specificity means less chance of false positives and translates into fewer unnecessary cystoscopies. That is what you want for your patient and your practice!

With the Bladder EpiCheck you get a biomarker urine test, which scores excellently in all areas and thus provides maximum support for your practice. You achieve what you want to achieve. You reduce your unnecessary cystoscopies to a maximum, with the least possible chance of missing HG disease.

Prof. Shahrokh F. Shariat: “Using Bladder EpiCheck as a rule-out test, can reduce 80% of cystoscopies without missing a single high-grade cancer”. (1)

The Bladder EpiCheck is a collaboration between MML Medical BV and Sanquin Diagnostics. With the Bladder EpiCheck @home collection kit, the execution of the test can now even take place entirely from the patient's home. Your patient will collect their urine at home with the ready-to-use Bladder EpiCheck @home collection kit at the moment you indicate. The patient sends the collected urine to Sanquin Diagnostics by regular mail. Sanquin Diagnostics will analyze and you will receive the result of the test. In the event of a negative result, you may consider replacing a cystoscopy.

Knowing more? Call 0315-642645 or mail with info@mml-medical.nl. We are happy to tell you more about the Bladder EpiCheck and the @home collection kit.

1. D'Andrea, D., Soria, F., Zehetmayer, S., Gust, K.M., Korn, S., Witjes, J.A. and Shariat, S.F. (2019), Diagnostic accuracy, clinical utility and influence on decision ‐ making of a methylation urine biomarker test in the surveillance of non ‐ muscle ‐ invasive bladder cancer. BJU Int, 123: 959-967. doi: 10.1111 / bju.14673


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