I haven't managed to assess this yet. I called Mandy Miller thinking she was working with the suppliers in Slough. I haven't received a reply, so today I have emailed nmp22@matritech.com. -:- Must call Mandy Miller of ‘Kyowa Hakko’ again (01753 566020)

16th May 10:07 Have just called Mandy wasn't available but someone else will look into it for me. Will call Germany Found 0049 761 478330. (http://www.matritech.de/) See if I can speak to Joe Hephler again.

Joe wasn't available but it was confirmed that the NMP22 uses the same goat - anti mouse derivative. I was told that no immunoassay can function without some animal derived antigen.

1. Nuclear Matrix Protein 22 (NMP22) What is it? cancerbackup.org.uk

" NMP22 stands for nuclear matrix protein 22. Bladder cancer cells release this protein into urine. So NMP22 is usually found at higher levels in the urine of people with bladder cancer than in the urine of healthy people. However, not all samples of urine contain high levels of NMP22 even when there is cancer in the bladder. This means the test may give a negative result even if there is a cancer. This is called a false negative result. A false negative result is more likely for early bladder cancers and for bladder cancers that are slow growing (low grade). "

2. Comparison of NMP22 and Cytology. ingentia.com

" Results: Of the 46 recurrences detected by cystoscopy, the NMP22 test was positive in 39 cases and cytology in 19 cases. The sensitivity of the NMP22 test was 85%, which was significantly greater than that of cytology (41%). In particular, for low-risk tumors it was eight times more sensitive than cytology. The specificities of the NMP22 test and cytology were 77 and 96%, respectively. Combining the two tests increased overall sensitivity to 91%. However, 9% of the tumors were still not detected.

Conclusion: The NMP22 BladderChek test is an in vitro qualitative test that is easily available and cheap; it can be performed by a urologist in the office and results can be interpreted within 30 min. The NMP22 test is superior to cytology for all grades and stages in the detection of recurrence in patients with a history of superficial bladder cancer. Our study indicates that the NMP22 test can be used as a substitute for urine cytology. The NMP22 test cannot replace cystoscopy, but it can be used as an adjunct to cystoscopy in the surveillance protocol for patients with superficial bladder cancer. "

3. Screening and monitoring for bladder cancer: refining the use of NMP22.

" In the 135 patients with increased NMP22 values the 46 identified tumors were accompanied by 89 false-positive values yielding a specificity of 83.9% and a positive predictive value of 34.1%. These false-positive results were divided into 6 clinical categories. Exclusion of these categories improved the specificity and positive predictive value of NMP22 to 99.2% and 92.0%, respectively, yielding results similar to urinary cytology (99.8% and 94.1%).
Conclusion: Awareness and exclusion of the categories of false-positive results can increase the specificity and positive predictive value of NMP22, enhancing the clinical use of this urinary tumor marker. "

4. library.nhs.uk

" What were the findings?
Bladder cancer was diagnosed in 79 of the 1,331 patients. The NMP22 test had a sensitivity (the proportion of patients with the disease who tested positive) of 56% and a specificity (the proportion of patients without the disease who tested negative) of 86%. Cytology had a sensitivity of 16% and a specificity of 99%. The NMP22 test detected four cancers that were not seen during the first cystoscopy but were detected on subsequent examinations, including three that were muscle invasive and one carcinoma in situ.

What were the authors' conclusions?
The non-invasive point-of-care assay for elevated urinary NMP22 protein can increase the accuracy of cystoscopy, with test results available during the patient visit.

The results of this study also show that the NMP22 assay had significantly lower specificity (86%) than cytology (99%). This means that around 14% of people without bladder cancer were diagnosed as having bladder cancer on the NMP22 test, compared to 1% on the cytology test, which indicates that cytology could be more useful as a single test for ruling in a diagnosis of bladder cancer. "