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Test ID: FCPP
Chlamydia Pneumoniae PCR

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Method Name A short description of the method used to perform the test

DNA amplification by polymerase chain reaction (PCR) with gel-electrophoresis of PCR products.

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Chlamydia Pneumonia PCR

Aliases Lists additional common names for a test, as an aid in searching

CHLPPCR FORWARD

Specimen Type Describes the specimen type needed for testing

Varies

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

0.5 mL serum, plasma, blood, fluids and other sources. Tissue with no fixative is also acceptable.

Ship frozen.

Note: Source required.

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

0.5 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis:

NA

Thawing:

Cold reject; Warm reject

Lipemia:

NA

Icterus:

NA

Other:

NA

 

 

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
VariesFrozen (preferred)180 days
 Refrigerated 72 hours
 Ambient 12 hours

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

TND – Target Not Detected

Positive – Virus Detected

 

This test employs PCR and agarose gel electrophoresis detection of a chlamydia pneumoniae-specific conserved genetic target. A positive result should be coupled with clinical indicators for diagnosis. A negative CHLPPCR result (TND) does not exclude chlamydia involvement in a disease process.

 

Test Performed by: University of Colorado Hospital

                             Clinical Laboratory

                             12401 E 17th Ave

                             Aurora, CO  80045

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Tuesday, Thursday

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

1 - 2 days

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

3 - 5 days

Performing Laboratory Location The location of the laboratory that performs the test

University of Colorado Hospital Clinical Laboratory

Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test was developed and its performance characteristics determined by the UCH Clinical Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendment of 1988 ("CLIA") as qualified to perform high complexity clinical testing.

CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

87486

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
Z2685SourceIn Process
Z2686Chlamydia PCRIn Process