58500:SWINE-ORIGIN INFLUENZA A/H1N1 (2009) DUPLEX by RT-PCR

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58500:SWINE-ORIGIN INFLUENZA A/H1N1 (2009) DUPLEX by RT-PCR
Alias Names: Flu A/Swine H1N1 / SWFLU RT PCR / /SOIA Detect / INFA / AOIA
Methodology: RT-PCR
Edit Date: 5/15/2010
Performed: Daily from 1 October – 30 April
Mondays from 1 May – 31 September
Released: 24-48 hours
CPT Code: 87798 x2
Specimen Collection Details
Collection: Using a sterile polyester flexible shaft nasopharyngeal swab, collect a nasopharyngeal specimen. Place the swab in M4/M4RT transport media. Also acceptable: Use of a sterile polyester flexible shaft nasopharyngeal swab in combination with a sterile polyester nasal swab(s). Collect a nasopharyngeal and a nasal specimen(s). Place the swab(s) in M4/M4RT transport media.
Handling: Refrigerate at 2-8° C, or freeze.
Stability: 48 hours refrigerated, or 3 months frozen. Unstable ambient.
Standard Volume: 3 mL transport medium.
Minimum Volume: 400 µL transport medium.
Transport: Refrigerated, or frozen on dry ice.
Comments: RT-PCR has a higher sensitivity to detect influenza viruses compared to rapid influenza A&B antigen testing. A negative rapid influenza A&B antigen test result does not rule out novel influenza A (H1N1) virus infection.

This test is not intended for the evaluation of anti-viral resistance of influenza A.

A positive result from an rt-PCR test meets the CDC definition of a laboratory-confirmed case of novel influenza A H1N1(2009). For formal confirmation testing (i.e. sequencing), clinicians should inquire with their local state health laboratories or the CDC at http://www.cdc.gov/h1n1flu/specimencollection.htm .

Rejection Criteria: Sputum; bronchoalveolar lavage (bronch wash); nasal aspirate; throat swab; nasal swab alone; leaking or non-sterile containers.

Analytical Characteristics
• Sensitivity 99%

• Specificity 98%

• Positive Predictive Value 92%

• Negative Predictive Value 100%