CertNDx Bladder Cancer Assay:
Use: Non-invasive test for patients with history of bladder cancer.
Methodology: The matrix metalloproteinase level for MMP-2 is determined by quantitative sandwich enzyme immunoassay (ELISA) technique. Vimentin and NID-2 status is determined by conventional methylation specific PCR. FGFR3 status is determined by Real-Time PCR analysis for mutations located in Exons 7, 10, and 15 of the FGFR3 gene.
CPT Codes: 83890, 83891, 83894, 83896, 83898, 83900, 83901, 83907, 83912, 86316
Volume: 40ml of voided urine required.
Complete the Urology Test Requisition:
- Indicate CertNDx Hematuria or Recurrence
- Note specimen type (i.e. random void)
- Record the urine collection date and time on the Urology Test Requisition.
- Write the patient’s name on four of the peel off labels.
- Securely adhere the labels to each of the BD Vacutainer tubes. (4 purple tops)
- Verify that the patient name and label # on the BD Vacutainer tubes matches the requisition form and urine containers. Please ensure complete insurance information is provided.
- Upon receiving the patient’s urine sample, place the urine collection cup on a flat surface or hold at an angle if the volume is very limited.
- Submerge the straw end of the BD Urine transfer straw into the urine specimen.
- Insert the first purple top BD Vacutainer tube into the other end of the transfer straw, rubber stopper end down, until the rubber stopper is pierced and the specimen is drawn into the tube.
- Hold the first purple top tube in position until it is filled. The tube has a 10 ml fill volume.
- Remove the first purple top BD Vacutainer tube from the transfer straw and insert the second purple top tube into the transfer straw.
- Hold the second purple top tube in position until it is filled.
- Repeat with the third and fourth purple top tubes.
- Remove the fourth purple top tube from the transfer straw and remove the transfer straw from the urine cup, letting the urine drain from the transfer straw.
- Mix the purple top tubes by inversion to dissolve the preservative.
- Discard the transfer straw as a contaminated sharp in an appropriate container.
- IF SHIPPING IMMEDIATELY, follow “Specimen Shipping Instructions”.
- If NOT shipping immediately, place the specimen in the refrigerator (2-8oC) until it can be shipped. DO NOT FREEZE SPECIMEN.
Discard any remaining urine and the urine cup.
Special Instructions: Urine specimen must be received at the testing laboratory within 72 hours of collection.
Printing the Shipping Document, Scheduling Commercial Carrier Pickup:
- Complete commercial carrier shipping document, including sender information.
- Select overnight delivery. All outgoing Friday shipments must be received by the following Monday.
- Schedule commercial carrier pickup.
- Insert shipping document into the commercial carrier document pouch and close resealable flap.
Packing the Shipping Container:
- Place the specimen in the biohazard bag and seal the bag.
- Place the completed requisition in the side pocket of the biohazard bag.
- Place sealed biohazard specimen bag into the shipping box.
- Close the cardboard box cover.
- Place the box into the commercial carrier packaging and seal closed.
- Remove commercial carrier document pouch backing and adhere pouch to the top of the commercial carrier packaging.
- Ship by overnight delivery to the testing laboratory.
Storage Instructions: If not shipping immediately, place the specimen in the refrigerator (2-8 degrees C) until it can be shipped. Do not freeze specimen.
- Messing EM and Catalona W.: Urothelial tumors of the urinary tract. In: Campbell’s Urology, 7th ed. Edited by PC Walsh, AB Retik, ED Vaughan Jr and AJ Wein. Philadelphia: W. B. Saunders 1998; chapt 77, pp 2327-2408.
- Donat SM, North A, Dalbagni G and Herr HW: Efficacy of office fulguration for recurrent low grade papillary bladder tumors less than 0.5 cm. J Urol 2004; 171: 636.
- Cookson MS, Herr HW, Zhang ZF, Soloway S, Sogani PC and Fair WR: The untreated natural history of high risk superficial bladder cancer: 15-year outcome. J Urol 1997; 158: 62.
- Leblanc B, Duclos AJ, Bénard F, Côté J, Valiquette L, Paquin JM et al: Long-term followup of initial Ta grade 1 transitional cell carcinoma of the bladder. J Urol 1999; 62: 1946.
- van Rhijn, B., Vis, N., van der Kwast, T., Kirkels, W., Radvanyi, F., Ooms, E., Chopin, D., Boeve´, E., Jobsis, A., Zwarthoff, E.: Molecular Grading of Urothelial Cell Carcinoma With Fibroblast Growth Factor Receptor 3 and MIB-1 is Superior to Pathologic Grade for the Prediction of Clinical Outcome. J Clin Oncol. 2003 May; 21(10):1912-1921.
- Moses, M.A., Wiederschain, D., Loughlin, K.R., Zurakowski, D., Lamb, C.C., Freeman, M.R.: Increased incidence of matrix metalloproteinases in urine of cancer patients. Cancer Res. 1998 Apr 1; 58(7):1395-9.
- Eissa, S., Ali-Labib, R., Swellam, M., Bassiony, M., Tash, F., El-Zayat, T.M.: Noninvasive diagnosis of bladder cancer by detection of matrix metalloproteinases (MMP-2 and MMP-9) and their inhibitor (TIMP-2) in urine. Eur Urol. 2007 Nov; 52(5):1388-96.
- Fernandez, C.A., Wszolek, M.F., Loughlin, K.R., Libertino, J.A., Summerhayes, I.C., Shuber, A.P.: A Novel Approach to Using Matrix Metalloproteinases for Bladder Cancer. J Urol. 2009 Nov; 182:2188-2194.
- Zuiverloon, T., van der Aa, M., van der Kwast, T., Steyerberg, E., Lingsma, H., Bangma, C., Zwarthoff, E.: Fibroblast Growth Factor Receptor 3 Mutation Analysis on Voided Urine for Surveillance of Patients with Low-Grade Non-Muscle-Invasive BladderCancer. Clin Cancer Res. 2010 June; 16(11):3011-3018.
- Renard, I., Joniau, S., van Cleyenbreugel, B., Collette, C., Naome, C., Vlassenbroeck, I., Nicolas, H., de Leval, J., Straub, J., Van Criekinge, W., Hamida, W., Hellel, M., Thomas, A., de Leval, L., Bierau, K., Waltregny, D.: Identification and Validation of the Methylation Specific Polymerase Chain Reaction Assays for the NonInvasive Detection of Primary Bladder Cancer in Urine Samples. Eur Urol (2009), doi: 10.1016/j.eururo.2009.07.041.
- Costa, V., Henrique, R., Danielsen, S., Duarte-Pereira, S., Eknaes, M., Skotheim, R., Rodrigues, A., Magalhaes, J., Oliveira, J., Lothe, R., Teixeira, M., Jeronimo, C., and Lind, G. Three Epigenetic Biomarkers, GDF15, TMEFF2, and VIM, Accurately Predict Bladder Cancer from DNA-Based Analyses of Urine Samples. Clin Cancer Res; 2010 Dec; 16(23): 5842-5851.
This product is a laboratory-developed test (LDT) provided as a service to physicians. This product is not an in-vitro diagnostic (IV) kit and is not sold directly to patients or to other laboratories.