Cytomegalovirus (CMV), Congenital, Qualitative PCR, Saliva Swab
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| 87496 |
Expected Turnaround Time
3 Days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
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3 Days |
Specimen Requirements
Specimen
Saliva swab
Volume
1 swab
Minimum Volume
1 swab
Container
Universal Transport Media (UTM); Viral Transport Media (VTM), including UVT, MART, M4 and M6
Collection
A saliva swab should be collected at least one hour after breastfeeding. Insert a sterile polyester swab into the baby's mouth between the gum and cheek and swirl for several seconds. Remove the swab and place into the UTM or VTM container. Carefully break the swab at the score line and submit for testing.
Storage Instructions
Refrigerate.
Per package insert: Refrigerated swabs are stable for 7 days. Frozen swabs are stable for 14 days (-20°C).
Causes for Rejection
Saliva swabs not submitted in UTM or VTM; saliva swabs submitted in non-approved collection containers; e-swabs or other collection devices intended for bacterial culture; collection containers submitted without a swab; saliva swabs submitted from patients >21 days of age
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Saliva swabs not submitted in UTM or VTM; saliva swabs submitted in non-approved collection containers; e-swabs or other collection devices intended for bacterial culture; collection containers submitted without a swab; saliva swabs submitted from patients >21 days of age Saliva swabs not submitted in UTM or VTM; saliva swabs submitted in non-approved collection containers; e-swabs or other collection devices intended for bacterial culture; collection containers submitted without a swab; saliva swabs submitted from patients >21 days of age |
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Saliva swabs not submitted in UTM or VTM; saliva swabs submitted in non-approved collection containers; e-swabs or other collection devices intended for bacterial culture; collection containers submitted without a swab; saliva swabs submitted from patients >21 days of age Saliva swabs not submitted in UTM or VTM; saliva swabs submitted in non-approved collection containers; e-swabs or other collection devices intended for bacterial culture; collection containers submitted without a swab; saliva swabs submitted from patients >21 days of age |
Test Details
Use
This test is intended for the in vitro qualitative detection of cytomegalovirus (CMV) DNA from salvia swabs collected in universal transport (UTM) or viral transport media (VTM) from infants <21 days of age. Results from this assay should be used in conjunction with the results of other clinical findings as an aid in the diagnosis of congenital CMV infection. Positive results from a saliva swab are presumptive and should be confirmed with urine.
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This test is intended for the in vitro qualitative detection of cytomegalovirus (CMV) DNA from salvia swabs collected in universal transport (UTM) or viral transport media (VTM) from infants <21 days of age. Results from this assay should be used in conju |
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This test is intended for the in vitro qualitative detection of cytomegalovirus (CMV) DNA from salvia swabs collected in universal transport (UTM) or viral transport media (VTM) from infants <21 days of age. Results from this assay should be used in conjunction with the results of other clinical findings as an aid in the diagnosis of congenital CMV infection. Positive results from a saliva swab are presumptive and should be confirmed with urine. |
Limitations
Results from this test must be considered in conjunction with clinical history, epidemiological data and other laboratory information available to the clinician evaluating the patient.
The detection of viral nucleic acid is dependent on proper sample collection, transport, handling, storage and preparation. Failure to observe proper procedures in any of these steps can lead to incorrect results.
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.
False negative results may occur if the viruses are present at a level that is below the analytical sensitivity of the assay or if the virus has mutations, insertions, deletions or rearrangements.
The prevalence of viral infections may affect the test's predictive value. As with other tests, false positive may occur.
Positive results from saliva swab screening for congenital CMV infection are considered presumptively positive and should be confirmed with detection of CMV in a urine sample.
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Results from this test must be considered in conjunction with clinical history, epidemiological data and other laboratory information available to the clinician evaluating the patient. The detection of viral nucleic acid is dependent on proper sample collection, transport, handling, storage and preparation. Failure to observe proper procedures in any of these steps can lead to incorrect results. 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. False negative results may occur if the viruses are present at a level that is below the anal The prevalence of viral infections may affect the test's predictive value. As with other tests, false positive may occur. Positive results from saliva swab screening for congenital CMV infection are considered presumptively positive and should be confirmed with detection of CMV in a urine sample. |
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Results from this test must be considered in conjunction with clinical history, epidemiological data and other laboratory information available to the clinician evaluating the patient. The detection of viral nucleic acid is dependent on proper sample collection, transport, handling, storage and preparation. Failure to observe proper procedures in any of these steps can lead to incorrect results. 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. False negative results may occur if the viruses are present at a level that is below the analytical sensitivity of the assay or if the virus has mutations, insertions, deletions or rearrangements. The prevalence of viral infections may affect the test's predictive value. As with other tests, false positive may occur. Positive results from saliva swab screening for congenital CMV infection are considered presumptively positive and should be confirmed with detection of CMV in a urine sample. |
Methodology
Polymerase chain reaction (PCR)
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 139865 | Congenital CMV PCR Saliva Swab | 83065-3 | 139866 | Cytomegalovirus (CMV), DNA | 83065-3 |
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