Sekisui Diagnostics OSOM Ultra Flu Influenza A & B Test

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OSOM Ultra Flu Influenza A & B Test

By Sekisui Diagnostics MFG Part #: 1006 SKU: SEKD1006
Promotion BUY 4 OSOM 1006 , Get 1 FREE See Details
Buy 4 OSOM Ultra Flu Influenza A & B Test Get 1 FREE, Promo Valid Through 11/30/18. Free goods fulfilled directly from manufacturer. Redemption Form
An in vitro rapid qualitative test that detects influenza type A and type B.
  • Sold By: 25 Per Box
  • Stock: 1000+
  • Usually ships in 1-3 Days
  • This product is non-returnable

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Overview

Product Description

The OSOM Ultra Flu A & B Test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection.

Sekisui Diagnostics announces the U.S. Food and Drug Administration (FDA) has granted Clinical Laboratory Improvement Amendments (CLIA) Waiver status for the OSOM Ultra Flu A&B Test using swab samples.

The OSOM Ultra Flu A&B Test delivers fast, accurate results in 10-15 minutes by utilizing a simple procedure across multiple sample types, including nasal swabs, nasopharyngeal swabs, and in moderate settings, nasopharyngeal aspirate/wash. The performance of the OSOM kit by users at CLIA waived sites was measured against the preferred standard of polymerase chain reaction (PCR), with a Positive Percent Agreement of 89.2% for Flu A and 86.4% for Flu B and Negative Percent Agreement of 99.4% for Flu A and 99.0% for Flu B.

CLIA waiver designation will enable healthcare providers to perform the OSOM Ultra Flu A&B Test using nasal or nasopharyngeal swabs, to deliver simple and accurate test results in locations such as the emergency room, community-based settings, urgent care and physician offices. By using the OSOM Ultra Flu A&B Test healthcare practitioners will provide patients with a rapid, accurate diagnosis while on site, thereby helping prevent unnecessary antibiotic prescriptions, reduce hospitalization, and minimize influenza transmission.4

Along with influenza, Sekisui Diagnostics provides a broad line of OSOM rapid tests for Strep A, Mononucleosis, Trichomonas, Bacterial Vaginosis, Helicobacter pylori, hCG and Fecal Occult Blood. Sekisui's expanding Point-of-Care product line also includes the FastPack IP System, which offers a convenient, rapid, decentralized testing solution for Vitamin D, Testosterone, PSA, Free PSA, TSH, Free T4, and hCG.

Features

  • CLIA Waived
  • Meets FDA Flu Classification Guidelines for Class II Devices.
  • SIMPLE PROCEDURE; Easy to use pre-measured extraction buffer for swab samples and unique cassette design for streamline workflow
  • CONFIDENT RESULTS; Easy, differentiated interpretation of results in 10-15 minutes
  • FLEXIBLE SPECIMEN TYPE; Accurate detection with nasal swabs, NP swabs and NP aspirate/wash samples. Compatible with viral transport media.

Specification

Type Rapid Tests
Sample size Swab
Test time 10 minutes
Sample Type nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash

About MFG

Sekisui Diagnostics is a global diagnostics company committed to improving patient lives by providing innovative medical diagnostic products to physicians and laboratories. Product lines include clinical chemistry systems and reagents, coagulation systems and reagents, infectious disease testing and rapid test kits, as well as enzymes and specialty bio-chemicals.

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