Test Catalog

Test Id : CCMVU

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Congenital Cytomegalovirus (cCMV), Molecular Detection, PCR, Urine

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the rapid diagnosis of cytomegalovirus infections in neonates 21 days of age or younger using urine specimens

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

Real-Time Polymerase Chain Reaction (PCR)

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

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Congenital CMV, PCR, Urine

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

CMV Detection by Real-Time PCR

Cytomegalovirus, PCR

CCMVU

Specimen Type
Describes the specimen type validated for testing

Urine

Ordering Guidance

This test should be ordered to test urine specimens from patients aged 21 days or younger. To test urine from patients older than 21 days, order CMVPV / Cytomegalovirus (CMV) Molecular Detection, PCR, Varies.

 

To test saliva specimens from patients aged 21 days or younger, order CCMVS / Congenital Cytomegalovirus (cCMV), Molecular Detection, PCR, Saliva. To test saliva from patients older than 21 days, order CMVPV / Cytomegalovirus (CMV) Molecular Detection, PCR, Varies.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Container/Tube: Plastic sterile container, 5 mL

Specimen Volume: 0.2 mL

Collection Instruction:

1. Collect a random urine from a urine bag, container, or catheter.

2. Transfer urine to sterile container.

3. No preservative

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.1 mL

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

  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Urine Frozen 72 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the rapid diagnosis of cytomegalovirus infections in neonates 21 days of age or younger using urine specimens

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Cytomegalovirus (CMV) is a double-stranded DNA virus of the Herpesviridae family. CMV is transmitted through direct contact from a variety of infected body fluids, as well as through sexual contact, organ transplantation, and intrauterine transmission during pregnancy.(1) CMV infection may be asymptomatic but can cause a wide range of symptoms, especially in immunocompromised individuals. Congenitally acquired CMV (cCMV) may lead to long-term sequelae, including visual and hearing impairments, and cognitive and motor deficits.(2) Current recommendations indicate testing urine and saliva swabs for cCMV using a nucleic acid amplification detection method.(3)

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.

Negative

Interpretation
Provides information to assist in interpretation of the test results

A positive result indicates the presence of cytomegalovirus (CMV) DNA in the patient sample.

 

A negative result indicates the absence of CMV DNA in the patient sample.

 

An invalid result indicates inability to conclusively determine presence or absence of CMV DNA in the patient sample.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test is not validated for sample types other than urine and saliva from infants 21 days of age or younger.

 

Negative results do not preclude cytomegalovirus (CMV) infection and should not be used as the sole basis for treatment or other patient management decisions.

 

False-negative results may occur if viral nucleic acid is present at a level that is below the analytical sensitivity of the assay or if the virus has genomic mutations, insertions, deletions, or rearrangements, or if the assay is performed very early in the course of illness.

 

The performance of this test has not been established for monitoring treatment of CMV infection.

Supportive Data

Accuracy:

To assess the accuracy of the Simplexa Congenital CMV (cytomegalovirus) Direct assay, clinical urine specimens (n=60) were tested and the results compared to those of a routine, lab-developed (LDT) CMV polymerase chain reaction (PCR) assay.(4) Results are summarized below in the Table.

 

Table. Urine Accuracy

Simplexa Congenital CMV Direct results

CMV LDT PCR results

 

Positive

Negative

Positive

31(a)

0

Negative

2(b)

26

Invalid

1(c)

0

 

a. One sample initially positive by CMV LDT PCR tested negative after frozen storage, but repeated positive results were obtained in triplicate by CMV LDT PCR (crossing point range: 36.94 to 40.00), and the sample was therefore included in accuracy experiments.

b. Two samples were negative by Simplexa but noted to have amplification curves and cycle threshold values (38.3 and 40.3) visible within the software, but outside of the defined positivity cutoff per the manufacturers instructions for use (< or =37.5). These samples were also positive by CMV LDT (Cp, 36.62 and 36.94 to 40.00 [see footnote a]), indicating the presence of CMV DNA at or below the limit of detection of the Simplexa cCMV Direct assay.

c. There was one initial Simplexa internal control failure; the urine sample was retested by Simplexa in singlet but repeated as invalid.

 

Simplexa cCMV Direct assay accuracy results for urine samples produced 91% positive agreement, 100% negative agreement, and 95% overall agreement.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Manicklal S, Emery VC, Lazzarotto T, Boppana SB, Gupta RK. The "silent" global burden of congenital cytomegalovirus. Clin Microbiol Rev. 2013;26(1):86-102. doi:10.1128/CMR.00062-12

2. Cannon MJ, Griffiths PD, Aston V, Rawlinson WD. Universal newborn screening for congenital CMV infection: what is the evidence of potential benefit?. Rev Med Virol. 2014;24(5):291-307. doi:10.1002/rmv.1790

3. Rawlinson WD, Boppana SB, Fowler KB, et al. Congenital cytomegalovirus infection in pregnancy and the neonate: consensus recommendations for prevention, diagnosis, and therapy. Lancet Infect Dis. 2017;17(6):e177-e188. doi:10.1016/S1473-3099(17)30143-3

4. Binnicker MJ, Espy ME. Comparison of six real-time PCR assays for qualitative detection of cytomegalovirus in clinical specimens. J Clin Microbiol. 2013;51(11):3749-3752. doi:10.1128/JCM.02005-13

5. Fernholz EC, Vidal-Folch N, Hasadsri L. Rapid and direct detection of congenital cytomegalovirus using a commercial real-time PCR assay. J Clin Microbiol. 2023;61(3):e0178122. doi:10.1128/jcm.01781-22

Method Description
Describes how the test is performed and provides a method-specific reference

The Simplexa Congenital CMV (cytomegalovirus) Direct assay is a real-time polymerase chain reaction system that enables the direct amplification and detection of CMV DNA from either saliva swab or urine specimens without nucleic acid extraction. The system consists of the Simplexa Congenital CMV Direct Reaction Mix, the LIAISON MDX (with LIAISON MDX Studio Software), the direct amplification disc, and associated accessories.

 

In the Simplexa Congenital CMV Direct assay, bifunctional fluorescent probe-primers are used together with corresponding reverse primers to amplify CMV DNA. A well-conserved region of the CMV UL83 gene is targeted to identify CMV DNA. An internal control is used to detect PCR failure and/or inhibition.(Package insert: Simplexa Congenital CMV Direct. Diasorin; REF MOL2255. Rev. 01, 11/2022)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

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

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 2 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

3 days

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

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87496

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CCMVU Congenital CMV, PCR, Urine 4999-9
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
620658 Congenital CMV, PCR, Urine 4999-9

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
New Test 2024-03-05