Qualitative assessment for presence or absence of a target

Scenario description

For certain disease assessments, a qualitative analysis with simply a positive or negative for the presence of a marker could be more important than quantifying the expression of the marker (Figure 11).

Detection of HPV infection in human samples using the RNAscope <sup>®</sup> 2.5 HD BROWN assay. The probe HPV-HR18 detects 18 high risk subtypes of the HPV E6/E7 gene. The condyloma tissue sample is negative for high risk HPV, whereas the Head and Neck tumor sample is positive for high risk HPV.

Figure 11. Detection of HPV infection in human samples using the RNAscope ® 2.5 HD BROWN assay. The probe HPV-HR18 detects 18 high risk subtypes of the HPV E6/E7 gene. The condyloma tissue sample is negative for high risk HPV, whereas the Head and Neck tumor sample is positive for high risk HPV.

Analysis guidelines

Within the cell population of interest, the assessment of marker expression needs to be reviewed in conjunction with the positive and negative control slides. If the positive and negative control slides have stained appropriately, and depending on the threshold previously set to determine positivity for that particular marker, the cells of interest could be called positive or negative for the marker.

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