| abstract |
The CAP-PAP Test is a double-staining, single-slide microscopic method. An in vitro diagnostic medical device for manual and automatic staining and interpreting of the Pap smear for cervical cancer screening, cervical dysplasia and for follow-up therapy can be developed using this double-staining, single-slide microscopic method. Abnormal cervical cells are labeled with an intracellular acid phosphatase derived pigment (azo-dye) to improve visibility of abnormal cervical cells on conventionally stained Pap smears. The enzyme marker improves human perception and/or sensitivity of automatic instruments when distinguishing cell a abnormality and interpretation of Pap smears. Increased accuracy of CAP-PAP-vs-Pap test is expected to reduce false negative readings of the conventional Pap test. A rapid manual version of the test that is low cost, does not require additional personnel training and is instantly applicable in all cytopathology laboratories is provided. The invention further provides a diagnostic kit, an automatic stainer and an automatic evaluation device for performing the double-staining, single-slide microscopic method. |