Osom Ultra Flu A And B Test
- 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
- Easy to use premeasured extraction buffer for swab samples and unique cassette design for streamline workflow
- Accurate detection with nasal swabs, NP swabs and NP aspirate/wash samples
- Compatible with viral transport media
- These items are NONRETURNABLE
- 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
- Easy to use premeasured extraction buffer for swab samples and unique cassette design for streamline workflow
- Accurate detection with nasal swabs, NP swabs and NP aspirate/wash samples
- Compatible with viral transport media
- These items are NONRETURNABLE
What Are Influenza Type A Flu And Type B Flu
Influenza A viruses are the most harmful, as they can cause severe disease. Wild aquatic birds are often the hosts for a large variety of influenza A viruses. Sometimes these viruses are transmitted from bird to human and can cause devastating outbreaks. Influenza B almost exclusively infects humans and is less common than influenza A. Flu type B also mutates about two to three times more slowly than influenza A. Because humans are the natural host of influenza B, pandemics generally do not occur with influenza B viruses.
Overview For Sekisui Diagnostics 1006 Osom Ultra Flu Influenza A& b Test 25/bx
The Sekisui Diagnostics OSOM Ultra Flu A & B Test is an in vitro rapid qualitative test that rapidly 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. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Provides fast and accurate results in 10 minutes. Cleared for use with multiple viral transport media types. Shelf life is 12-15 months.
Checkout the manufacturers instruction video here.
Replaces the Discontinued 190 Osom® Influenza A & B Test Kit
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Rapid Influenza Diagnostic Tests
| These tests provide results in 10-15 minutes and differentiate between influenza A and B | |||
|---|---|---|---|
| Manufacturer | |||
| Binax Now Influenza A & B Card 2 | DIGIVALTM | ||
| BD Veritor Flu A + B | BD Veritor Reader | ||
| BD Veritor Flu A + B | BD Veritor Plus Analyzer | ||
| Sofia® Influenza A + B FIA | Sofia FIA Analyzer | NS, NPS, NPA, NPW direct, NP, NPA, NPW in VTM | Yes |
| Sofia® Influenza A + B FIA | Sofia 2 FIA Analyzer | NS, NPS, NPA, NPW direct, NP, NPA, NPW in VTM | Yes |
| LABSCO Advantage Flu A & BLifeSign LLC Status Flu A & BOraSure QuickFlu Rapid A + BPolymedco Poly stat Flu A & BSekisui Diagnostics OSOM® ULTRA Flu A & BMeridian BioScience ImmunoCard STAT Flu A& BMcKesson Consult Diagnostics Influenza A& B | N/A | ||
| BD Veritor Flu A + B | BD Veritor Reader | NPW, NA, NPS in VTM | No |
| BD Veritor Flu A + B | BD Veritor Plus Analyzer | NPW, NA, NPS in VTM | No |
| Acucy Influenza A& B Test | The Acucy System | ||
| OSOM Ultra Plus Flu A& B Test | N/A | ||
| CareStart Flu A& B Plus | N/A | NPS | No |
FDA = U.S. Food and Drug AdministrationN = nasalN/A = RIDT does not use analyzer deviceNP = nasopharyngealVTM = viral transport mediaW = wash
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Sekisui Osom Ultra Flu A& b Test Using Swab Samples
Sekisui Diagnostics have announced the U.S. Food and Drug Administration has granted Clinical Laboratory Improvement Amendments 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 , 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.
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. Sekisuis 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.
Read more here: www.sekisuidiagnostics.com
Recommended Reading: Is The Flu Shot Good To Get
Sekisui Diagnostics Announces Launch Of New Products For Flu Ifob And Hcg Testing
LEXINGTON, Mass., Oct. 27, 2015 /PRNewswire/ — Today, Sekisui Diagnostics announces the launch of three new rapid tests as additions to the OSOM portfolio. Providing accurate results with minimal hands on time, OSOM Ultra Flu A& B and OSOM Ultra hCG Combo complement the existing Flu and hCG product lines, while the OSOM iFOB provides a new diagnostic option for fecal occult blood testing.
The OSOM Ultra Flu A& B Test provides qualitative results in 10-15 minutes by utilizing a simple assay procedure with minimal hands-on time. The Ultra Flu A& B Assay provides accurate results for both Flu A and Flu B viral infections across multiple sample types. The OSOM Ultra Flu A& B Test is projected to meet the currently pending FDA reclassification requirements for Rapid Flu Tests in the US Market.
The OSOM Ultra hCG Combo Test provides qualitative hCG results in 3-5 minutes utilizing a single-step procedure with less than 30 seconds of hands-on time. In studies, the Ultra hCG Combo assay demonstrated highly accurate results with 100% sensitivity and 100% specificity for urine samples and 100% sensitivity and 99% specificity for serum samples. The OSOM Ultra hCG Combo Test also detects hCG -core fragments, reducing the risk of interference when testing urine samples from later stages of pregnancy.
The three new OSOM products will be initially launched in the United States through our current distribution partners, with the potential to expand internationally in the future.
Student Health Center Manuals
CLIA: Moderate
Principle: The QuickVue+ Strep A Test is a lateral flow immunoassay, containing a highly specific and sensitive antibody to Group A Strep antigen.
To perform the test, a Swab specimen from a throat or a beta-hemolytic colony is collected. Antigen is extracted from the Swab specimen with Reagents A and B. The extracted sample is added to the Test Cassette.
If the sample contains Strep A antigen, a pink vertical line forms in the Read Result Window. The pink vertical line, together with the pre-printed blue horizontal line , forms a plus sign to indicate a positive result. If Strep A is not present in the sample, the Read Result Window shows on the pre-printed blue horizontal line, forming a minus sign to indicate a negative result.
As the sample continues to moves through the test, the control Window containing Strep A antigen becomes pink. Pink color in the Control Window indicates that the detection antibody is functionally active and is also evidence that the detection part of the test is functioning properly.
The appearance of blue color in the Test Complete Window indicates the completion of the test. This occcurs approximately 5 minutes after the addition of the extracted sample to the Test Cassette.
Reagents and Materials Supplied
Warnings and Precautions
Kit Storage and Stability:Store kit at room temperature, 59 deg F to 86 deg F . Kit contents are stable until the expiration date printed on the outer box. Do not freeze.
Culture Confirmation
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