Bordetella pertussis/parapertussis DNA, Qualitative, Real-Time PCR

Test Code
11365

CPT Codes
87798 (x2)

Includes
Bordetella pertussis DNA and Bordetella parapertussis DNA

Preferred Specimen
Minimum: 0.3 mL of Nasopharyngeal aspirate collected in a sterile vial, or nasopharyngeal swab collected in Liquid Amies collection tube

Other Acceptable Specimens
Nasopharyngeal swab submitted in a V-C-M medium (green-cap) tube, or equivalent UTM or multi-microbe media (M4), or eSwabs (Liquid Amies)

Instructions
Nasopharyngeal aspirates:
Instill 1-1.5 mL of nonbacteriostatic saline (pH 7.0) into one nostril. Flush a plastic catheter or tubing with 2-3 mL of saline. Insert the tubing into the nostril parallel to the palate. Aspirate nasopharyngeal secretions. Repeat this procedure for the other nostril. Combine aspirates into a sterile vial.

Nasopharyngeal swab:
Collection kits using Amies liquid, M4, VCM/UTM are acceptable. Swab tips may be polyester, rayon, nylon flocked. Flexible shafts must be used for proper collection. Accuracy of the test depends on the collection of ciliated epithelial cells material. Half the distance from the nostril to the base of the ear could be used as estimation of the site of collection. Gently insert swab into the nostril. Keep the swab near the septum floor of the nose while gently pushing into the posterior nasopharynx. Rotate swab 2-3 times and hold in place for few seconds for optimal collection. Collection of both nostrils is recommended but not required.

Transport Temperature
Refrigerated (cold packs)

Specimen Stability
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Collection tubes with Amies gel or charcoal containing media • Samples collected using cotton or calcium alginate tipped swabs • Rigid shaft swabs

Methodology
Real-Time Polymerase Chain Reaction (PCR)

This test detects but does not distinguish between B. Pertussis and B. Holmesii.

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Daily a.m.; Report available: 1-2 days

Reference Range
B. pertussis DNA Not detected
B. parapertussis DNA Not detected


Clinical Significance
Bordetella pertussis is the cause of whooping cough that may occur in unimmunized individuals. B. parapertussis is a related organism that causes a similar, but milder, disease. Laboratory diagnosis may require both culture and serological confirmation, although culture is difficult.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.