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BD Directigen™ Flu A Test Kit
Cat. # Desc. Qty. Unit
256020 BD Directigen™ Flu A Test Kit 1 EA
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Intended Use:

The Directigen™ Flu A Test is an in vitro immunoassay membrane test for the direct rapid and qualitative detection of influenza A viral antigen from suitable specimens of symptomatic patients. Nasopharyngeal wash and aspirate specimens have been shown to be superior to nasopharyngeal and throat swab specimens and are the specimens of choice with the Directigen Flu A Test. All negative test results should be confirmed by cell culture because negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

Catalog # Description Quantity Unit
256020 BD Directigen™ Flu A Test Kit
(20 tests) containing: one 5.0 mL bottle Extraction Reagent A , one 7.5 mL bottle Wash Reagent 1 , one 4.7 mL bottle Wash Reagent 2 , one 4.3 mL bottle Detector Reagent 3 , one 7.5 mL bottle Wash Reagent 4 , one 7.3 mL bottle Wash Reagent 5 , one 4.5 mL bottle Substrate A, Reagent 6 , one 3.9 mL bottle Substrate B, Reagent 7 , one 4.1 mL bottle Stop Reagent 8 , one 2 mL bottle Positive Control , one 2 mL bottle Negative Control , 20 ColorPAC™ devices with flow control units , DispensTube™ devices ,
 1 EA


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Directigen™ Flu A
For the direct detection of Influenza A Antigen
Revision: 0906    Revision Date: 09/01/2006   
Intended Use: «

The Directigen™ Flu A Test is an in vitro immunoassay membrane test for the direct rapid and qualitative detection of influenza A viral antigen from suitable specimens of symptomatic patients. Nasopharyngeal wash and aspirate specimens have been shown to be superior to nasopharyngeal and throat swab specimens and are the specimens of choice with the Directigen Flu A Test. All negative test results should be confirmed by cell culture because negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

Intended Use: » Intended Use:

The Directigen™ Flu A Test is an in vitro immunoassay membrane test for the direct rapid and qualitative detection of influenza A viral antigen from suitable specimens of symptomatic patients. Nasopharyngeal wash and aspirate specimens have been shown to be superior to nasopharyngeal and throat swab specimens and are the specimens of choice with the Directigen Flu A Test. All negative test results should be confirmed by cell culture because negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

Product Summary: «

Procedures currently used to diagnose influenza Type A infection include serologic assays, direct specimen immunofluorescence (IF) and culture isolation with confirmation procedures.1,2,3 The latter is considered the standard method and employs initial viral isolation in cell culture followed by hemadsorption inhibition, immunofluorescence, or neutralization assays to confirm the presence of the influenza virus.4,5,6 The Directigen Flu A antigen detection test employs an immunomembrane filter assay to detect influenza A antigen extracted from suitable specimens from symptomatic patients. Total test time is less than 15 minutes with reactivity determined by visual color development. Antigenic drift is not an issue with the Directigen Flu A Test because the target antigen is the nucleoprotein which is type specific and highly conserved.7

The speed and workflow of Directigen Flu A make it applicable as a "STAT" influenza A antigen detection test – providing rapid, relevant information to assist with specific antiviral intervention and other clinical or support decisions.

Product Summary: » Product Summary:

Procedures currently used to diagnose influenza Type A infection include serologic assays, direct specimen immunofluorescence (IF) and culture isolation with confirmation procedures.1,2,3 The latter is considered the standard method and employs initial viral isolation in cell culture followed by hemadsorption inhibition, immunofluorescence, or neutralization assays to confirm the presence of the influenza virus.4,5,6 The Directigen Flu A antigen detection test employs an immunomembrane filter assay to detect influenza A antigen extracted from suitable specimens from symptomatic patients. Total test time is less than 15 minutes with reactivity determined by visual color development. Antigenic drift is not an issue with the Directigen Flu A Test because the target antigen is the nucleoprotein which is type specific and highly conserved.7

The speed and workflow of Directigen Flu A make it applicable as a "STAT" influenza A antigen detection test – providing rapid, relevant information to assist with specific antiviral intervention and other clinical or support decisions.

User Quality Control: « User Quality Control:

Each Directigen Flu A ColorPAC device contains both internal positive and negative controls (i.e., two levels). The appearance of a purple control dot provides an internal positive reactivity control that validates the immunological integrity of the device, proper reagent function, and assures that the correct test procedure was followed. The membrane area surrounding the triangle is the internal negative control for the device. The lack of any significant color development in this background area indicates that the test has been performed correctly.

Liquid Positive (Control +) and Negative (Control –) controls are also supplied with each kit. These controls are provided as a means of additional quality control. At a minimum, the liquid controls should be run as a quality control procedure for each lot of each shipment received. The formation of a purple triangle on the membrane when the Control + is employed further indicates that the influenza A antigen binding property of the membrane is functional. Do not use if the Control + and Control – do not give appropriate results.

The liquid controls may also be used to demonstrate a positive or negative reaction. As described under "Test Procedure" the Control + will demonstrate a strong positive reaction. Dilution (1:2 maximum) of the Control + with saline may be performed and tested to demonstrate a weaker positive reaction. Performance of reagents and technique may also be evaluated by using specimens known to be positive or negative.

Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent CLSI (formerly NCCLS) guidance and CLIA regulations for appropriate Quality Control practices.


Reagents: « Reagents:

The Directigen Flu A Test kit includes:

ColorPAC Devices


DispensTube™ Tubes and Tips

Reagent A

Reagent 1

Reagent 2

Reagent 3


Reagent 4

Reagent 5

Reagent 6

Reagent 7

Reagent 8

Control +


Control –		 (20)


(20)

(5.0 mL)

(8.5 mL)

(4.7 mL)

(4.3 mL)


(8.5 mL)

(7.3 mL)

(4.5 mL)

(3.9 mL)

(4.1 mL)

(2.0 mL)


(2.0 mL)		 20 Test kit. Devices with flow controller units, containing a control dot
of inactivated influenza A (H1N1) antigen in the center of the membrane.

20 Test kit.

Extraction, 1.6% mucolytic agent and 6.4% detergent, with 0.2% sodium azide (preservative).

Wash, 150 mM citric acid.

Wash, 50 mM Tris and rabbit IgG with 0.2% sodium azide (preservative).

Detection, anti-influenza A monoclonal murine antibodies (2) – alkaline
phosphatase conjugated, with 0.2% sodium azide (preservative).

Wash, 5% butanol, 2M urea and 100 mM Hepes with 0.2% sodium azide (preservative).

Wash, 50 mM Tris and 150 mM NaCl with 0.2% sodium azide (preservative).

Substrate A, 0.4 mM chromogen, with 0.02% sodium azide (preservative).

Substrate B, 7.8 mM chromogen, with 0.2% sodium azide (preservative).

Stop, 150 mM citric acid.

Positive Control: inactive, detergent-treated influenza A
antigen (H1N1) with 0.2% sodium azide (preservative).

Negative Control: detergent-treated non-infected
egg fluid, with 0.2% sodium azide (preservative).

Warnings and Precautions: « Warnings and Precautions:

For in vitro Diagnostic Use.

1. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

2. Pathogenic microorganisms, including hepatitis viruses, Human Immunodeficiency Virus and novel influenza viruses, may be present in clinical specimens. "Standard Precautions"8-11 and institutional guidelines should be followed in handling, storing and disposing of all specimens and all items contaminated with blood and other body fluids.

3. Differences in performance may be observed when this test is used on specimens from adults versus from children, but specific differences are not known.

4. Do not use reagents beyond the expiration date.

5. Do not mix reagents from different kit lot numbers or mix reagent bottle caps.

6. Do not reuse ColorPAC device. Incubation times and temperatures other than those specified may give erroneous results.

7. Hold reagent bottles vertically (approximately one inch from the ColorPAC membrane surface or tube), while gently dispensing one drop at a time, in quick succession to ensure proper drop delivery.

8. Avoid contact of reagents with skin and mucous membranes. If reagents come into contact with these areas, flush with water and contact your physician.

9. Reagents contain sodium azide, which is harmful if inhaled, swallowed or in contact with skin. Contact with acids liberates very toxic gas. After contact with skin, wash immediately with plenty of water. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up.

10. Use polyester or rayon-tipped swabs with an aluminum wire for nasopharyngeal swabs (NPS); e.g., BBL™ CultureSwab™ Mini-Tip swab (see "Availability"). Calcium alginate swabs are not recommended for use with Directigen Flu A.

11. Do not use the kit if the Control + and Control – do not yield appropriate results.

12. Remove the ColorPAC device from the foil pouch just prior to use.

13. The Influenza A Control + has been prepared from influenza A (H1N1)-infected egg fluid which has been inactivated with detergent and subsequently tested by bio-assay procedures.



Information shown on this page is a short summary extracted from the Package Insert, available as a PDF under the Related Documents section of this page.