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Table of Contents Page USP 38-NF 32 14. 16. 17. 18. 19. 17.  … 20. 21. 22. USP 38-NF 32.
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Urinary Tract Infection – Laboratory Tests

The aim of these guidelines is to determine a level of verification of laboratory products and services that will maximize the information base upon which decisions can be made.

This revision is being published as a companion document to Supplement 27, USP Chapter IX, Conditions for Compliance with the Performance Tested Method. No new guidelines have been developed. The performance test and associated guidelines for the chemical,. The urinary tract infections laboratory test is defined as a diagnostic test performed on a patient with clinically suspected UTI.

A specimen for testing must be obtained before the patient begins to urinate, usually from the midline of the urinary tract. An indwelling catheter is not permitted.

Detailed instructions for the performance of the test are included in the USP Performance Tested Methods, Volume 31, Chapter 9, Clinical Diagnostic Tests. If the test results are to be used as reference values for a patient population, the method and the use of appropriate statistical techniques in data analysis to account for different degrees of contamination of the specimens must be performed as set forth in USP Chapter X, Statistical Principles of Methodology and Inference.

The intended use of the test is to distinguish infections of the upper urinary tract, lower urinary tract, and mid-calf regions.

A contemporary review of all available bibliographic data was undertaken to ascertain the value of the test. The test has been used for more than 25 years and has proven to be a reliable test for the diagnosis of UTI by various categories of clinicians.

Although there are published interpretations of how different clinical entities such as UTI, pyelonephritis, vaginitis, and asymptomatic bacteriuria (ABU) should be diagnosed, no single test offers a conclusive diagnosis.

Therefore, although the value of the test has been shown in the diagnosis and treatment of the above clinical syndromes, there is a risk that, in the hands of nonclinicians or less-experienced clinicians, the results can be misinterpreted.

This could lead to the use of unnecessary laboratory or empiric antimicrobial therapy, which could be expensive, invasive, or both.

Clinicians must be aware of the limitations and the potential problems with the test and must use their knowledge of the physiology of the urinary tract to separate the infectious processes from those that are noninfectious in nature.

Symptoms and signs of UTI in women include frequency
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