Community Health Care, Inc

003-108 Rapid Influenza A/B

COMMUNITY HEALTH CARE, INC.

The medical/laboratory director or the director’s designee should review all copies of this procedure at least once a year. The director should keep a log of the copies being maintained.

Reviewed by: / Date: / Comments:

Policy/Procedure #: 003-108

Subject: Henry Schein Influenza A/B Test

Department(s) Affected/Distribution: Lab

Effective Date: 12/15/2014

Origination Approval: Signature on file Date: 12/15/2014

Revision Approval: Date:

References: Henry Schein Influenza A/B test package insert

POLICY: It is the policy of Community Health Care, Inc. (CHC) laboratory to use the Henry Schein Influenza A/B test for the qualitative detection of Influenza A/B.

PROCEDURE:

A.  Specimen

1.  Nasal Swab

a.  For optimal performance, use the swabs supplied in the test kit. Alternatively, sterile nylon flocked, foam or rayon nasal swabs can be used to collect samples. Do no use alginate swabs.

2.  Test as soon as possible

3.  Nasal swab may be stored at room temperature in a clean, dry, tightly sealed plastic tube for up to 8 hours.

4.  Always refer to the kit package insert before testing.

B.  Quality Control

1.  External Quality Control – External controls are used to assure that the reagents are performing properly and that you are able to correctly perform the test procedure. Each kit contains external Influenza A and B positive and viral negative control swabs. Quality controls should be run at least:

a.  Once with each new shipment received

b.  Once with each new kit lot, and

c.  Once by each new untrained operator before he/she tests patient samples

-  External Positive Control –A positive result is indicated by one red line and one blue line.

-  External Negative Control –A negative result is indicated by one blue line.

2.  Internal Quality Control

a.  Each Influenza A/B kit has built-in procedural controls.

b.  An untested test strep has a yellow line at the control position. If the test flows correctly and the reagents are working properly, this yellow line will always turn blue on the test strip.

c.  The clearing of background color on the test strip is a negative background control. The background color should be light pink to white within 10 minutes. Background color should not interfere with the reading of the test result.

d.  For each sample tested, the user should confirm that the blue internal control line is present before reading the result.

C.  Procedure

1.  Open a foil pouch just before testing and remove the test strip, coated reaction tube and the workstation.

2.  Label the tube with two patient identifiers.

3.  Make sure the purple coating is in the bottom of the reaction tube, if it is missing, do not use the contents of the pouch. Get a new one.

4.  Take the cap off the reaction tube and put the reaction tube in the workstation

5.  Twist off the top of a reagent 1 vial and squeeze all of its contents directly into the bottom of the coated reaction tube.

6.  Put the sample swab to be tested into the reaction tube. Mix the swab in the liquid for about 10 seconds. Press the swab head against the side of the tube as you mix it. This helps to remove the sample from the swab. Make sure all of the purple coating in the tube is mixed in well.

7.  While squeezing the tube around the swab head, remove the swab from the reaction tube. This removes sample from the swab. Discard the swab.

8.  Put a test strip into the reaction tube so the arrows on the test strip point down.

9.  Start a timer for 10 minutes. Do not handle or move the test strip until 10 minutes are up.

10.  At 10 minutes, remove the test strip from the tube and read the result.

D.  Interpretation of Results

1.  Positive Result – ANY red Test Line (A or B) along with a blue Control Line (c) is a positive result for the detection of influenza A or B.

2  Negative Result – A blue Control Line (c) and no red Test Line is a negative result.

5.  Invalid Test – The test result is invalid if a blue Control Line (c) is not visible at 10 minutes.

6.  Record patient and Quality Control results in the log book and report it in the LIS.

E Limitations

1.  A negative result does not exclude infection with influenza A or B.

2.  Visibly bloody samples are not recommended

3.  Children tend to shed virus more abundantly and for longer periods of time than adults. Therefore, in vitro diagnostic tests for influenza may have lower detectability in adults than in children.

DAILY PATIENT LOG- Influenza A/B

CHC Influenza patient log 12/14