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Test ID: FCMVQ
CMV by PCR

Secondary ID A test code used for billing and in test definitions created prior to November 2011

91734

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

No

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

Polymerase chain reaction (PCR)

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

CMV Quant PCR

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

CMVQNT FORWARD
Cytomegalovirus Quant FORWARD

Specimen Type Describes the specimen type needed for testing

Amniotic Fld

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.

1 mL amniotic fluid shipped frozen.

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

Warm reject; Cold OK

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
Amniotic FldFrozen180 days

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 (Negative)

POS<1000 – Positive – Virus detected below 1000 copies/mL

>1,000,000 copies/mL - Greater than maximum quantitative range

 

REFERENCE NOTE: This test employs real-time amplification of a CMV-specific conserved genetic target.   A positive result should be coupled with clinical indicators for diagnosis.  A negative CMVPCR result (TND) does not exclude CMV involvement in a disease process.

 

Test Performed by: Univ 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.

Monday through Friday

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 day

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

2 -3 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 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.

87497

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
Z0161CMV Quant PCRIn Process