Bordetella pertussis detection by PCR in nasopharynx

1. Polyester
2. Rayon
3. Flocked Nylon

1. Liquid Amies
2. Liquid Stuart
3. Sterile container (red top tube)

1. Copan Transport System
2. Eswab

Unpreserved samples or samples stored in transport media should be tested as soon as possible, but may be held at room temperature (21-30°C) for up to 5 days or refrigerated (2-8°C) for up to 7 days prior to testing. Do not freeze samples.

• Aspirin was found to interfere with Alethia Pertussis testing at concentrations greater than 5 mg/mL.

• The Alethia Pertussis assay targets the IS481 insertional element of Bordetella genome.The IS481insertional element is present in B. pertussis, B. holmesii and some strains of B. bronchiseptica.
• The Alethia Pertussis DNA assay is a qualitative assay and does not provide quantitative values or information about organism load.
• This device has not been evaluated for the monitoring treatment of Bordetella pertussis infections.
• This test has not been evaluated for specimens other than nasopharyngeal swab specimens.
• B. parapertussis which causes pertussis-like illness is not detected by the Alethia Pertussis DNA assay.  Illness caused by B. parapertussis is generally milder than illness caused by B. pertussis because the organism does not produce pertussis toxin.
• Positive results do not preclude co-infection with other respiratory pathogens.
• False-negative B. pertussis results are more likely if patients are tested later in the disease course (more than 2 weeks after symptom onset), due to declining Bordetella DNA. False-negative results may also be increased in patients treated with antibiotics.
• Environmental contamination of an exam room from a prior patient or a recent pertussis vaccination administration may result in false-positive result.
• The detection of nucleic acid is dependent upon proper specimen collection, handling, transportation, storage and preparation.Failure to observe proper procedure in any one of these steps can lead to incorrect results.

Reference Range:
Negative

Reportable Range:
Positive: Sample contains B. pertussis target DNA

Negative: No B. pertussis DNA detected OR Below limit of detection

Invalid: Interfering substances