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The BTA stat® Test Package Insert - Part 1

   

A Rapid Test For the Qualitative Detection of Bladder Tumor
Associated Antigen in Human Urine

Caution: U.S.A. Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory, and use is restricted to, by or on the order of a physician.

THE CONTENTS OF THIS SITE IS FOR INFORMATION ONLY. When performing assay please refer to the most current package insert which accompanies multiple-test kits. 


INTENDED USE

The BTA stat test is an in vitro immunoassay intended for the qualitative detection of bladder tumor associated antigen in urine of persons diagnosed with bladder cancer. This test is indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy.


SUMMARY AND EXPLANATION OF THE TEST

Bladder Cancer
Bladder cancer is the fourth most common form of cancer in men and ninth most common form in women in the United States.
1 Approximately 75 to 85% of these patients present with transitional cell carcinoma (TCC) confined to the superficial mucosa of the bladder.2 The risk of recurrence in these patients is 75%. Patients with previous diagnosis of bladder cancer have been routinely followed for recurrence by urine cytology and cystoscopy. Both methods have their limitations.
Cystoscopy is considered the diagnostic standard for sensitivity and specificity when a biopsy is not obtained. This method is an invasive procedure associated with patient discomfort, is expensive and is limited to diagnosis of those tumors that can be visualized.
3


Voided urine cytology (VUC), or the examination of urinary sediment for cancer cells, has several characteristics that contribute to suboptimal results. Urothelial cells require about a year to replicate, so few are available for examination in any particular sample.
3 Exfoliated cells enter a hostile environment of high acidity and low osmolality which may obscure essential diagnostic features. Standards for specimen collection, preservation, processing and interpretation have not been widely accepted. Routine cytology, as a monitoring tool exhibits variable sensitivity depending on the tumor stage and grade with lowest sensitivity reported for early stage disease.4,5 In addition, the best quality results are obtained from examination of samples collected under specific voiding procedures.4


The management of patients with bladder cancer could be improved with a rapid, simple, urine test that could be performed at point of care or in the laboratory. Recent studies have shown that the BTA stat test, which qualitatively detects bladder tumor associated antigen can be extremely useful in this regard.
6,7 The BTA stat test is a single-step, antibody based test which is performed in only 5 minutes with no pretreatment of the urine sample. 


Bladder Tumor Associated Antigen
The monoclonal antibodies used in the BTA stat test were generated against urine components from patients with histologically confirmed bladder cancer. Bladder tumor associated antigen was identified as human complement factor H related protein (hCFHrp) similar in composition, structure and function to human complement factor H (hCFH).
8,9 hCFH, which is also recognized by the monoclonal antibodies utilized in the BTA stat test, is found in human plasma at concentrations of approximately 480 g/mL. In cell culture, hCFHrp was shown to be produced by several human bladder cancer cell lines, but not by normal epithelial cell lines.8,9 Using in situ hybridization methods in tumor specimens, hCFHrp was shown to be produced by cancer cells and macrophages but not by normal epithelia .


hCFH plays a key inhibitory role in the control of the alternative complement pathway that functions to lyse cells recognized as foreign to the host. By interaction with complement factor C3b, hCFH serves to inhibit the formation of a membrane attack complex, thereby preventing cell lysis.
10 In vitro, bladder tumor associated antigen interrupts the complement cascade and protects cells from lysis by complement. This inhibitory effect can be reversed by the use of monoclonal antibodies specific for hCFHrp.11 Production of bladder tumor associated antigen may confer a selective growth advantage to cancer cells in vivo by allowing the cells to evade the host immune system.


PRINCIPLE OF THE PROCEDURE

The BTA stat test is an immunoassay utilizing two different monoclonal antibodies (MAbs) to specifically detect the presence of bladder tumor associated antigen in urine. Each MAb specifically binds to a different epitope on the target antigen (hCFHrp). One MAb serves as the hCFHrp capture agent. The second MAb is conjugated to colloidal gold and serves as the reporter molecule if hCFHrp is present in the specimen. 


Patient urine is added to the sample well of the device and allowed to react with the colloidal gold-conjugated reporter antibody. If the antigen is present in the sample, it will interact with the conjugate to form an immune complex. The reaction mixture flows through the membrane which contains zones of immobilized antibodies. In the Patient (P) zone, antigen-conjugate complexes are trapped by the capture antibody, forming a visible line. In the absence of the antigen in the patient urine, no visible line will form. The procedural Control (3) zone contains an immobilized goat anti-mouse IgG-specific antibody which will capture the conjugated antibody independently of the presence or absence of the antigen, thereby always producing a line. This procedural control assures the operator that each device is working properly.


CONTRAINDICATIONS

  • Do not use beyond the labeled expiration date.

  • Do not reuse disposable test devices. Discard after single use.

  • Do not use if pouch is damaged or opened.

  • Do not touch the membrane located within the windows.


WARNINGS AND PRECAUTIONS

  • For in vitro diagnostic use.

  • To avoid cross-contamination of samples, use a new dropper (provided with each device) for each patient urine.

  • Treat urine samples and used devices as if they are potentially infectious. 


DEVICES AND REAGENTS

BTA stat Test Device - individually packaged in a sealed foil pouch with a urine dropper and a desiccant. Each device incorporates a membrane-immobilized murine anti-hCFHrp capture MAb and a conjugated murine anti-hCFHrp MAb in a protein matrix containing sodium azide. The procedural Control zone contains an immobilized goat anti-mouse IgG-specific antibody in a protein matrix containing sodium azide.


STORAGE AND STABILITY

Store the BTA stat test kit at 2 - 30C. Do not freeze. The test kit is stable when stored at these temperatures until the expiration date printed on the box label. NOTE: For simplicity and to prevent the storage of medical devices in home refrigerators, the Instructions for Home Use recommend room temperature storage only. 


INDICATIONS OF DEVICE DETERIORATION

If a BTA stat test device fails to produce a line in the procedural Control (3) window when used according to the Patient Test Procedure, the test is invalid and must be repeated with a new device. 


SPECIMEN COLLECTION, STORAGE AND PRESERVATION

Voided urine or urine from a catheterized patient is required for the BTA stat test. Bladder barbotage specimens, serum, plasma or whole blood should not be used. Urine should be collected without preservatives or fixatives in a clean urine cup and labeled appropriately. If urine is to be used for other tests, remove an aliquot of the specimen (a minimum of 2 ml) for this test to avoid contamination. Swirl the urine before testing. Urine samples may be stored at room temperature for up to 48 hours after collection. If the urine sample is not tested within 48 hours, it should be refrigerated at 2 - 8C for up to 7 days. If the refrigerated urine sample is not tested within 7 days, it should be stored at or below -20C until tested. A frozen sample is stable for 24 weeks at -20C including up to 4 freeze/thaw cycles. NOTE: For simplicity and to prevent the storage of urine samples in home refrigerators, the Instructions for Home Use recommend room temperature storage only. If test is provided to patient for home use, supply patient with a plastic urine collection cup. 

  • Do not use paper or foam cups for urine specimen collection or storage.

  • The effect of radiation therapy or systemic chemotherapy on the BTA stat test is unknown.

  • The effect of treatment with intravesical agents, such as BCG, mitomycin C, Thiotepa, bropiramine (investigational) or interferon (investigational), is unknown.

  • The antigen concentration variation in first morning urine specimens has not been determined. 

  • The effects of experimental drugs on the BTA stat test are unknown.

  • Some patients with benign renal disease (such as stones and nephritis), urinary tract infections, cystitis, sexually transmitted diseases or renal cancer including upper tract TCC may yield positive results with the BTA stat test.

  • For trauma to the bladder or urinary tract due to surgery, biopsy, etc., the physician should allow ample time for trauma recovery before using the test.


MATERIALS REQUIRED BUT NOT PROVIDED

  • Timer

  • Urine collection container (do not use paper or foam cups)

  • Positive and Negative External Controls, e.g. BTA stat Test Control Kit (Cat. No. 661105) 


 

CLICK HERE FOR PART 2 OF PACKAGE INSERT

 Product Info     Package Insert     References     Principle of The BTA stat Test     BTA TRAK Assay info