FDA Approves PCT Test

New Antibiotic Management For Lower Respiratory Tract Infections And Sepsis Cleared By FDA

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FDA has given a green signal for the expanded use of a procalcitonin test to help determine the use of antibiotics in patients who suffer from lower respiratory infection and sepsis. This has enabled physicians come to important decisions regarding the optimum use of antibiotics.

With the approval, this Vidas Brahms PCT test assay will help in clinical situations where unnecessary and inappropriate usage of antibiotics occurs. This can now help to slow and prevent the emergence of resistant bacteria and antibiotic resistant infections. This test becomes the first and only FDA cleared procalcitonin test available in the US market for physicians.[1]

Incidence of Lower Respiratory Tract Infections (RTIs) and Sepsis

 RTIs are common across all age groups and are a leading cause for emergency hospital admissions and clinic visits. Lower respiratory tract infections include community acquired pneumonia, acute bronchitis and acute exacerbations of chronic obstructive pulmonary disease (COPD). Many times LRTI are treated with antibiotics even when most cases do not require them.

Sepsis is a severe condition which can be life threatening and fatal. Approximately 30 million people in the world are affected by sepsis each year.[2] The key here is rapid diagnosis and administering the most appropriate antibiotic therapy as well as knowing when to stop the therapy. [1]

WORKING OF PCT ASSAY

This test works by measuring the levels of PCT as PCT levels provide information about which type of infection may be present. High levels of PCT suggest a bacterial infection while lower levels suggest a viral or non infectious cause. PCT is a protein associated with body’s response to bacterial infection and can serve as a biomarker for antibiotic management.

About Vidas Test

This automated immunoassay platform is designed for emergency situations. With its broad menu, it enables clinicians to monitor, diagnose and also track the prognosis for a number of diseases mainly in the field of infectious diseases.

This test will be used primarily in hospital settings and emergency settings according to FDA. There have been concerns regarding false positive or false negative results to prompt physicians to unnecessarily stop or continue antibiotics in certain patients.

Hence, health care providers should not only rely on results of this PCT test when coming to a decision but must corroborate the result according to the patient’s status and other laboratory results.

This test has got approval based on the promising results from clinical trials that were presented at an FDA advisory committee [1] in November 2016. The Vidas Brahms test has been cleared through the 510 (k) pathways which is a regulatory pathway for certain medical devices that are equivalent to a legally marketed device. Clinical trial findings that compared PCT guided therapy to standard therapy showed significant decrease in antibiotic use in persons who had received PCT guided therapy. This did not affect any aspect of safety.

Physicians should review the test’s package insert for complete information regarding clinical use and performance.

The Vidas Brahms test is manufactured by bioMerieux Inc. in Marcy l’Etoile, France.

Credit: Dr. Rachita on behalf of Borderless Access

Copyright © 2017 BorderlessAccess

Reference Sources:

  1. FDA clears test to help manage antibiotic treatment for lower respiratory tract infections and sepsis
  2. World Sepsis Day Fact Sheet. Global Sepsis Alliance. Center for Sepsis Control & Care.

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