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QuickVue© Influenza AB diagnostic test CLIA Waived

An all inclusive, point of contact, diagnostic test kit for the rapid detection of Influenza Virus Type A and B infection. Using a self administered, nasal discharge collection swab, the complete test is performed in three easy to follow steps. So simple and easy, in fact, that this Influenza AB test is CLIA waived. Test kit includes 25 test procedures and includes all components and reagents required to diagnose Influenza A and B infection. Includes a color coded procedure card simplifying the three basic steps of the test. No instrumentation or special training is required. Accurate diagnostic results in 10 minutes or less. CPT Reimbursement CODE 87804

IMPORTANT NOTE: This test version tests for A and B Type Virus. It does not identify which virus type (A or B) is present.

INTENDED USE

The QuickVue Influenza Test is a simple to use, rapid, qualitative lateral flow immunoassay for the detection of Influenza Virus type A and type B antigens directly from a self administered nasal specimen swab. The test kit is self contained and intended for use as an aid in the rapid diagnosis of acute influenza virus infection.

SUMMARY AND EXPLANATION

Influenza is highly contagious, acute, viral infection of the respiratory tract. The causative agents of the disease are immunologically diverse, single-strand RNA viruses known as influenza viruses. There are three types of influenza viruses: A, B, and C. Type A viruses are the most prevalent and are associated with most serious health risks and epidemics. Type B viruses promote a disease that is generally milder then that caused by type A. Type C viruses are a highly stable and less infectious causing either minor discomfort or no symptoms at all. All influenza viruses are contracted primarily by the inhalation of airborne contaminated micro droplets from other infected individuals. Because the disease is so contagious, influenza can be epidemic in proportions infecting many individuals at the same time. The virus primarily attacks the respiratory track weakening the immune system and potentially leading to serious complications like pneumonia especially in the elderly with other chronic health problems. The early diagnosis of influenza is useful in prescribing the correct medications and recuperative treatment for the disease. Recently, antibiotic treatment of influenza has been developed. Drugs called neuraminidase inhibitors, as well as Amantadine and Rimantadine, are effective in decreasing symptoms if given within two days of the onset of symptoms. These drugs can also prevent influenza in patients at high risk, including the elderly or those with immune deficiency, when given during epidemics to unvaccinated patients.

PRINCIPLE OF THE TEST

The QuickVue© Influenza Test involves the extraction of influenza A and B viral antigens. A swab containing a nasal discharge specimen is placed in a special extraction tube with the supplied test reagent solution during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. The Influenza Test Strip is then placed in the extracted reagent solution where nucleoproteins in the specimen will react with the reagents impregnated on the test strip. If the extracted specimen contains influenza antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. If influenza type A or type B antigens are not present or are present at very low levels, only a blue procedural Control Line will appear. For information including specificity, sensitivity, expected values, cross reactivity and analytical data see the Influenza AB Test Technical Insert.

TEST COMPONENTS SUPPLIED:

Each QuickVue Influenza AB test kit comes boxed containing all the materials required to perform twenty-five (25) test procedures:

Procedure kit Contents for each Test Procedure

•  QuickVue© Influenza Test Strip impregnated anti-A and anti-B influenza antibodies
•  Extraction Reagent Solution vial with 250 ml saline
•  Extraction Tube with lyophilized buffer, detergents and reducing agents
•  Disposable Dropper
•  Sterile Collection Swab
• 
Procedure Card and complete instruction sheet.
 

TEST BASICS:

Using the nasal swab provided, a specimen of nasal discharge is obtained by rotating the swab several times inside the nostril. The swab is then placed in the extraction tube with the extraction reagent solution and again rotated several times to release the collected specimen into  solution. After this extraction process, the Influenza Test Strip is then dipped in the solution. Migration of the sample across the test area of the strip then begins and development of test results take place in approximately 10 minutes. Test results are then interpreted and read according to the chart shown.

Influenza AB Test Technical Insert

CPT Reimbursement CODE 87804

AVAILABILITY:

The QuickVue© Influenza Test is available in a clinical/physicians boxed kit of 25 test procedures. Each QuickVue© influenza boxed test kit is sealed with all the required test components to perform 25 Influenza AB test procedures. Clear step by step instructions are included with each test kit. Physician CPT Code 87804.

Description Packaging Sale Unit

Cost

 

QuickVue© Influenza A/B Test

Physician Boxed (25 tests per box)

1 box (25 Tests)

$435.00

 

 

2 Boxes (50 Tests)

$820.00

 

 

4 Boxes (100 Tests)

$1,560.00

*If the order buttons are absent or inoperable, please use the pricing overview page to order.

Influenza AB Test Technical Insert
Note: For information including specificity, sensitivity, expected values, cross reactivity and analytical data see the Influenza AB Technical Insert.


 

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