Ordering Recommendations

This qualitative PCR test is used for congenital screening of neonates for CMV-associated hearing loss. Diagnosis of congenital CMV is critical for disease management and intervention. Neonatal screening in either saliva or urine and confirming in urine is recommended for a definitive diagnosis for congenital CMV based on testing guidelines. 

This test is only for infants less than 21 days of age. 

Collect

Saliva flocked swab
Urine: 1 mL (Min: 0.5 mL)

Specimen Container

Preferred Saliva Collection Device: UTM with flocked swab 


Acceptable Saliva Collection Device: Remel M4RT or similar with flocked swab 


Urine: Sterile, leak-proof container, containing no preservative

 

Specimen Preparation

None

Storage/Transport Temperature

Saliva flocked swab in UTM: Refrigerated
Urine: Send STAT Refrigerated 

Unacceptable Conditions

Saliva flocked swab in any transport media other than UTM, UVT, Remel M4RT, M4, M5 or M6. No swab in collection tube. Calcium alginate or cotton swabs. Specimen not received in tranport media.
Urine: Urine in preservative. Delayed transport (greater than 2 hours at room temperature or greate than 8 hours refrigerated).

Remarks

Specimen source required.

Stability (from collection to initiation)

Saliva flocked swab in UTM:  Ambient: 48 hours; Refrigerated: 7 days; Frozen: 14 days
Urine: Ambient: 2 hours; Refrigerated: 8 hours; Frozen:  3 days

Notes

Do not collect saliva sample within one hour of breastfeeding. 
This test should not be used to monitor treatment of CMV.

Ordering Recommendations

This qualitative PCR test is used for congenital screening of neonates for CMV-associated hearing loss. Diagnosis of congenital CMV is critical for disease management and intervention. Neonatal screening in either saliva or urine and confirming in urine is recommended for a definitive diagnosis for congenital CMV based on testing guidelines. 

This test is only for infants less than 21 days of age. 

EPIC Order Code

LAB99969

Sunquest Code

CCMV

Synonyms

  • LAB99969
  • Congenital cytomegalovirus
  • Congenital CMV
  • Qualitative CMV
  • CMV congenital hearing loss
  • CMV PCR Saliva
  • CMV qualitative, saliva
  • HHV-5
  • Human herpesvirus 5

CPT Codes

87496

LOINC

  • 83065-3
  • 4999-9

LOINC Table

83065-3
4999-9

Reference Interval

Not Detected

Interpretive Data

Negative results do not rule out congenital CMV infections and should not be used as the sole basis for treatment or other patient management decisions.

Positive results from a saliva or urine sample should be confirmed with a subsequent urine sample. 

This test has only been evaluated for infants of less than 21 days of age.

This test does not provide the quantitative value (i.e. viral load) and should not be used to monitor response to treatment of CMV infection.
Collection

Ordering Recommendations

This qualitative PCR test is used for congenital screening of neonates for CMV-associated hearing loss. Diagnosis of congenital CMV is critical for disease management and intervention. Neonatal screening in either saliva or urine and confirming in urine is recommended for a definitive diagnosis for congenital CMV based on testing guidelines. 

This test is only for infants less than 21 days of age. 

Collect

Saliva flocked swab
Urine: 1 mL (Min: 0.5 mL)

Specimen Container

Preferred Saliva Collection Device: UTM with flocked swab 


Acceptable Saliva Collection Device: Remel M4RT or similar with flocked swab 


Urine: Sterile, leak-proof container, containing no preservative

 

Specimen Preparation

None

Storage/Transport Temperature

Saliva flocked swab in UTM: Refrigerated
Urine: Send STAT Refrigerated 

Unacceptable Conditions

Saliva flocked swab in any transport media other than UTM, UVT, Remel M4RT, M4, M5 or M6. No swab in collection tube. Calcium alginate or cotton swabs. Specimen not received in tranport media.
Urine: Urine in preservative. Delayed transport (greater than 2 hours at room temperature or greate than 8 hours refrigerated).

Remarks

Specimen source required.

Stability (from collection to initiation)

Saliva flocked swab in UTM:  Ambient: 48 hours; Refrigerated: 7 days; Frozen: 14 days
Urine: Ambient: 2 hours; Refrigerated: 8 hours; Frozen:  3 days

Notes

Do not collect saliva sample within one hour of breastfeeding. 
This test should not be used to monitor treatment of CMV.
Ordering

Ordering Recommendations

This qualitative PCR test is used for congenital screening of neonates for CMV-associated hearing loss. Diagnosis of congenital CMV is critical for disease management and intervention. Neonatal screening in either saliva or urine and confirming in urine is recommended for a definitive diagnosis for congenital CMV based on testing guidelines. 

This test is only for infants less than 21 days of age. 

EPIC Order Code

LAB99969

Sunquest Code

CCMV

Synonyms

  • LAB99969
  • Congenital cytomegalovirus
  • Congenital CMV
  • Qualitative CMV
  • CMV congenital hearing loss
  • CMV PCR Saliva
  • CMV qualitative, saliva
  • HHV-5
  • Human herpesvirus 5
Fees & Codes

CPT Codes

87496

LOINC

  • 83065-3
  • 4999-9

LOINC Table

83065-3
4999-9
Clinical & Interpretive

Reference Interval

Not Detected

Interpretive Data

Negative results do not rule out congenital CMV infections and should not be used as the sole basis for treatment or other patient management decisions.

Positive results from a saliva or urine sample should be confirmed with a subsequent urine sample. 

This test has only been evaluated for infants of less than 21 days of age.

This test does not provide the quantitative value (i.e. viral load) and should not be used to monitor response to treatment of CMV infection.
Lab Use Only

Test Information

Performing Lab
Deaconess Oakley St. Laboratory
Methodology
Qualitative Real-Time PCR
Performed
Mon-Sat
Reported
Within 1-3 days