Order ZstatFlu®.
		A timely predictive diagnosis of Influenza A&B with ZstatFlu® gives physicians control over influenza disease. ZstatFlu bridges the gap between vaccination & treatment and completes a comprehensive Influenza Management Program. Now CLIA Waived! On December 4, 2000, the ZstatFlu® test was classified as a waived test by the FDA under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Waived status greatly expands the number of physicians and facilities that can utilize the test. Waived tests "employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible of pose no reasonable risk of harm to the patient if the test is performed incorrectly." According to the FDA, the CLIA waiver "allows a lab to perform the test without having to meet national personnel, quality assurance and proficiency testing standards." CLIA regulations require that all entities that perform waived laboratory tests must have a Cerificate of Waiver, or higher laboratory certification. For more information about Clia Categorization, certification and how to obtain a Certificate of Waiver, you may click on any of the links below: • FDA CLIA Pages http://www.fda.gov/cdrh/clia/ • CDC CLIA Pages http://www.phppo.cdc.gov/dls/clia/default.asp • HCFA CLIA Pages http://www.hcfa.gov/medical/clia/cliahome.htm • CLIA and the Physicians Office Lab: Intepretive Guidelines http://www.vh.org/providers/CMS/CLIA/LabGuidelines?A10Test.html • HCFA Forms http://www.hcfa.gov/forms • CLIA Application for Certification Form HCFA-116 http://www.hcfa.gov/medicaid/clia/cliaapp.htm • State Survey Agencies (CLIA Contact LIst) http://www.hcfa.gov/medicaid/clia/ssa-map.htm This new 20 minute, throat swab, 99%* specific test allows physicians to: • know when flu is present in your practice • provide a predictive diagnosis • allow for early antiviral diagnosis • protect your chronically ill & over 65 patients from complications Increase the quality of healthcare by: • predictive diagnosis leads to antiviral treatment • reduces the likelihood of complications of flu • reduces antibiotics Reduce the cost of healthcare by: • improve utilization of time & reduces lab costs • prevent unnecessary hospitalization • decrease treatment costs ZstatFlu is an easy rapid 4-step flu test • utilizes a throat swab • four easy steps • hands-on time just one minute • results in 20 minutes • easily transportable to reference laboratory, waived facilities can utilize this rapid diagnostic test. • built-in pH check for test verification • easy-to-control controls that do not require refrigeration The ZstatFlu® diagnostic test delivers results in 20 minutes. Performance depends on the strain of influenza. In a high prevalence testing environment the test will correctly identify as many as 99% of negative results, will have a predictive value of a positive result that may be as high as 99%, and will pick up as many as 62% of positive results. Available for Physician Office Laboratories or Hospital & Reference Laboratories * please refer to package insert
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