Bordetella pertussis/parapertussis PCR

Real-time polymerase chain reaction (PCR) based qualitative in virto diagnostic test for the direct detection and identification of Bordetella pertussis and Bordetella parapertussis nucleic acid in a nasopharyngeal swab specimen

The DiaSorin Bordetella assay targets the Insertion sequences IS481 for B. pertussis and IS1001 for B. parapertussis.

Limitation: The IS481 is also found in B. holmesii.

Negative results do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens.

Reference Ranges:

Bordetella pertussis: Negative
Bordetella parapertussis: Negative

Interpretation: A positive result indicates the presence of DNA from Bordetella pertussis or B parapertussis.

A negative result indicates the absence of detectable B pertussis and B parapertussis DNA in the specimen but does not negate the presence of organism or active or recent disease and may occur due to inhibition of PCR (known inhibition rate of <1%), sequence variability or the presence of B pertussis or B parapertussis in quantities less than the limit of detection of the assay. Additionally, patients presenting late after symptom onset may test negative; in such cases, testing for B pertussis antibody, IgG, in serum may be considered.

Collection Note: The high sensitivity of amplification by PCR requires the specimen to be processed in an environment in which contamination of the specimen by Bordetella pertussis or Bordetella parapertussis DNA is unlikely.

Collect one of the following:

• Nasopharyngeal swab (Flocked, Rayon or Polyester) placed in Copan Universal Transport Media (UTM) or an ESwab
  Reject Due To: Nose, nasal, or throat swab; calcium alginate or cotton-tipped swab; swab sent in gel transport medium, or Regan Lowe media; swabs with solid plastic shaft; dry swab.

Refrigerate sample in original collection container.

Stability: Refrigerated (preferred): 7 days; Frozen: 7 days.

Reject Due To: Nose, nasal, or throat swab; calcium alginate or cotton-tipped swab; swab sent in gel transport medium, viral/universal transport medium, or Regan Lowe media; ; swabs with solid plastic shaft; dry swab.