PCR is the CDC-recommended test for detection of Bordetella pertussis and Bordetella parapertussis in patients suspected of having active, untreated pertussis and is preferred over culture because it is faster and demonstrates improved sensitivity.
This test requires prior authorization (PA) and should be placed as a future order in the outpatient setting. If unable to obtain PA, please have patient sign a financial waiver.
Orderable SIM Number(s)
B. PERTUSSIS/PARAPERTUSSIS NAT, AMPLIFIED (LAB923)
Synonyms
Whooping Cough
b. pert
b. para
BPCR
PCR
LAB923
Collect
Dry nasopharyngeal (NP) swab in plastic sleeve (Swabs are availiable from ARL)
Acceptable swab types:
flocked
dacron
rayon
Also acceptable:
NP swab in Amies semi-solid gel with charcoal transport medium
Specimen Preparation
If culture is also ordered, a second swab MUST be obtained and sent separately. See Bordetella pertussis culture.
Storage/Transport Temperature
Refrigerated
Unacceptable Conditions
Incorrect source or transport conditions
Calcium alginate swabs
Eswabs
Swabs in UTM
Stability (from collection to initiation)
Refrigerated 7 days
Frozen 1 month
Reference Interval
Negative or Positive
Additional Reference Interval
Detection of B. pertussis or B. parapertussis is an infection control notifiable result.
Interpretive Data
This test is performed on the BD Max using real-time polymerase chain reaction to detect the insertion sequences IS481 of Bordetella pertussis and IS1001 of Bordetella parapertussis. A positive result indicates the presence of DNA from Bordetella pertussis or Bordetella parapertussis. The IS481 insertion sequence is also present in the genome of Bordetella holmesii and therefore, specimens containing B. holmesii may yield false-positive results. B. parapertussis and B. holmesii cause a pertussis-like illness that is generally milder than pertussis because the bacteria do not produce pertussis toxin. Because of the high sensitivity of the PCR assay and the ability of PCR to detect non-viable organisms, specimens may be positive by PCR and negative by culture. A negative result indicates the absence of detectable Bordetella pertussis or Bordetella parapertussis DNA in the specimen but does not negate the presence of organisms or active or recent disease and may occur due to inhibition of PCR (<1% inhibition rate), sequence variability of emerging strains, or the presence of B. pertussis or B. parapertussis in quantities less than the limit of detection of the assay. The PCR result should be interpreted in conjunction with patient history and clinical presentation.
Notes
This test was developed and its performance characteristics determined by Aspirus Reference Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA does not require this test to go through premarket FDA review. This test is for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical testing.
CPT Codes
87798 x 2
LOINC
41875-6
Overview
Ordering Recommendations
PCR is the CDC-recommended test for detection of Bordetella pertussis and Bordetella parapertussis in patients suspected of having active, untreated pertussis and is preferred over culture because it is faster and demonstrates improved sensitivity.
This test requires prior authorization (PA) and should be placed as a future order in the outpatient setting. If unable to obtain PA, please have patient sign a financial waiver.
Orderable SIM Number(s)
B. PERTUSSIS/PARAPERTUSSIS NAT, AMPLIFIED (LAB923)
Synonyms
Whooping Cough
b. pert
b. para
BPCR
PCR
LAB923
Specimen
Collect
Dry nasopharyngeal (NP) swab in plastic sleeve (Swabs are availiable from ARL)
Acceptable swab types:
flocked
dacron
rayon
Also acceptable:
NP swab in Amies semi-solid gel with charcoal transport medium
Specimen Preparation
If culture is also ordered, a second swab MUST be obtained and sent separately. See Bordetella pertussis culture.
Storage/Transport Temperature
Refrigerated
Unacceptable Conditions
Incorrect source or transport conditions
Calcium alginate swabs
Eswabs
Swabs in UTM
Stability (from collection to initiation)
Refrigerated 7 days
Frozen 1 month
Interpretive
Reference Interval
Negative or Positive
Additional Reference Interval
Detection of B. pertussis or B. parapertussis is an infection control notifiable result.
Interpretive Data
This test is performed on the BD Max using real-time polymerase chain reaction to detect the insertion sequences IS481 of Bordetella pertussis and IS1001 of Bordetella parapertussis. A positive result indicates the presence of DNA from Bordetella pertussis or Bordetella parapertussis. The IS481 insertion sequence is also present in the genome of Bordetella holmesii and therefore, specimens containing B. holmesii may yield false-positive results. B. parapertussis and B. holmesii cause a pertussis-like illness that is generally milder than pertussis because the bacteria do not produce pertussis toxin. Because of the high sensitivity of the PCR assay and the ability of PCR to detect non-viable organisms, specimens may be positive by PCR and negative by culture. A negative result indicates the absence of detectable Bordetella pertussis or Bordetella parapertussis DNA in the specimen but does not negate the presence of organisms or active or recent disease and may occur due to inhibition of PCR (<1% inhibition rate), sequence variability of emerging strains, or the presence of B. pertussis or B. parapertussis in quantities less than the limit of detection of the assay. The PCR result should be interpreted in conjunction with patient history and clinical presentation.
Notes
This test was developed and its performance characteristics determined by Aspirus Reference Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA does not require this test to go through premarket FDA review. This test is for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical testing.
Coding
CPT Codes
87798 x 2
LOINC
41875-6
Performed
Performed
Monday - Sunday
Daily
Reported/Turnaround Time
Reported
1-3 days
Methodology
Methodology
Qualitative PCR
Orderable SIM Number
Orderable SIM Number(s)
B. PERTUSSIS/PARAPERTUSSIS NAT, AMPLIFIED (LAB923)
