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Sangia Total PSA Test - U. S. Pharmacist The Sangia Total PSA Test eliminates the long waiting periods by reducing waiting time to 10 minutes 12 The blood is collected using a capillary blood sample from a fingerstick, whereas traditional total PSA tests require testing in a central laboratory equipped to exclusively perform laboratory assessments, with results available in days or
Summary of Safety and Effectivness (SSED)Template At each site, each subject was tested with the Sangia Total PSA Test by three(3)operators, each operator collected the fingerstick sample from different fingers from the same subject Of 72subjects, eight(8)were excluded due to the Sangia Total PSA result outside the measuring rangeandthree (3)were excluded for lacking valid Sangia Total PSA
FDA approves new type of PSA testing methodology The Sangia Total Prostate Specific Antigen (PSA) Test consists of a Cassette Assembly and a Sample Collector The Sangia Total PSA Test is used as an aid in the diagnosis of prostate cancer This new test is the first point-of-care test that can deliver PSA results near where the patient is being evaluated, for example at the doctor’s office
(PDF) Sangia Total PSA Test - ResearchGate With the prick of a finger, this device can determine a patient’s total PSA level within 10 minutes The Sangia Total PSA Test Sample Collector and Casset Assembly inserted into a Claros 1 Analyzer
New FDA approved finger prick test detects prostate cancer . . . The Sample Collector connects to the Cassette Assembly that is then inserted into the Claros 1 Analyzer to complete the test Each sample runs on a Sangia Total PSA Test Cassette includes a separate positive and negative control check that must be passed for the Claros 1 Analyzer to report a total PSA sample result
OPKO Health Receives FDA Approval for the Point-of-Care . . . MIAMI, Feb 01, 2019 (GLOBE NEWSWIRE) -- OPKO Health, Inc (NASDAQ: OPK) today announced that the U S Food and Drug Administration (FDA) has approved the Company’s point-of-care Sangia Total Prostate Specific Antigen (PSA) Test using the Claros 1 Analyzer The product is indicated to quantitatively measure total PSA in whole blood from a
FDA approves OPKOs point-of-care PSA test - MedTech Dive Testing PSA levels typically entails taking a venous blood sample and sending it to a laboratory OPKO developed the Sangia Total PSA Test to accelerate the process by cutting out the laboratory, enabling physicians to learn a patient’s PSA level at the point of care