Hampson / Roche
Pap Test Significantly
Improves Pap Smear
Accuracy
Women across Australia
will be relieved that new
Pap testing technology,
clinically trialed by
Hampson Pathology,
has proven to identify significantly
more abnormalities than
the traditional Pap smear.
FINDINGS
Comparing conventional Pap smear diagnosis with Roche CytoRich Pap smear diagnosis
in our clinical trial of 4,500 patients indicate:
1. Abnormality detection is higher
13* (2.3%) additional abnormalities were detected from the additional specimen which
could not be found on the conventional Pap smear despite careful rescreening.
2. Smears are cleaner and more easily interpreted
The incidence of unsatisfactory smears has been reduced from 207 (4.6%) to 26
(0.6%) with CytoRoch and reduced to 8 (0.2%) using two tests
3. Fewer patients need to return for a follow- up smear
181 patients from our trial of 4,500 patients were saved the inconvenience of re-
collection
4. A multi-test strategy provides the greatest accuracy.
The highest accuracy is achieved by combining the results of both tests, the traditional
Pap smear plus the Hampson/ Roche test
ACTION
The test will be routinely available from Hampson Pathology in the near future. The
collection stage of the clinical trial is now complete. The additional test is not covered by
Medicare and an additional fee will apply.
Clinical Trial Results
Objective: To measure the sensitivity and specificity of a multi-test strategy in cervical cancer detection.
Design: A double blind study by pathologists and cytotechnologists of:
1. Conventional Pap Smear
2. Additional specimens prepared by Roche CytoRich monolayer preparation system
3. Diagnosis based on the combined results of both tests
Method: To collect the Pap Smear in a conventional manner and harvest additional cells normally discarded on the collection device.
These additional cells are then prepared using the Roche CytoRich machine. A comparison of this specimen and the conventional Pap smear from the same patient is used to estimate the sensitivity of each test and the sensitivity of both tests combined.
Preliminary Results:
Conventional Pap Diagnosis Versus CytoRich Pap Diagnosis
| * | Conv Normal | Conv ASCUS | Conv LGSIL | Conv HGSIL | Conv Invasive | Conv Unsat | Total - CytoRich |
|---|
| CRP Normal | 3644 (81) | 335 (7.4) | 8 (0.2) | 2 (<0.1) | 0 | 190 (4.2) | 4179 (92.9) |
|---|
| CRP ASCUS | 126 (2.8) | 56 (1.2) | 24 (0.5) | 1 (<0.01) | 0 | 7* (0.2) | 214 (4.8) |
|---|
| CRP LGSIL | 4* (0.1) | 11 (0.2) | 49 (1.1) | 3 (0.1) | 0 | 2* (<0.1) | 69 (1.5) |
|---|
| CRP HGSIL | 0 | 0 | 0 | 10 (0.2) | 0 | 0 | 10 (0.02) |
|---|
| CRP Invasive | 0 | 0 | 0 | 0 | 2 (<0.1) | 0 | 0 |
|---|
| CRP Unsat | 15 (0.3) | 2 (<0.1) | 0 | 1 (<0.1) | 0 | 8 (0.2) | 26 (0.6) |
|---|
| Tot-Conv | 3789 (84.2) | 404 (9) | 81 (1.8) | 17 (0.4) | 2 (<0.1) | 207 (4.6) | 4500 (100) |
|---|
Key:
ASCUS: atypical squamous cells of undetermined significance
LGSIL: low grade squamous intraepithelial lesion (HPV and/or CIN1)
HGSIL: high grade squamous intraepithelial lesion (CIN 2-3)
* 13 additional abnormalities detected
Conclusion:
The Roche CytoRich monolayer preparation screened in conjunction with the conventional Pap smear significantly improves the chance of abnormal cell detection.
Hampson Pathology recommended that the two test Pap stategy be implemented as a standard measure for increased sensitivity and a reduction in re-collections.
Online for the future
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Updated 12th April 1996
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© CMS Medialink 1996