Test Details
Methodology
Nucleic Acid Amplification
Result Turnaround Time
2 - 4 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.
Use
This test detects influenza A and influenza B by nucleic acid amplification. If influenza A is detected, a second test will be performed to confirm the presence of influenza A and to determine if the subtype is H5. This test should be used only for patients who meet the most current clinical and epidemiological criteria for H5-specific testing, as recommended by the U.S. Centers for Disease Control and Prevention. This test is validated for nasopharyngeal (NP) collections only and is intended to be used for patients presenting with respiratory symptoms consistent with influenza-like illness (ILI). Patients at risk for Influenza A/H5 and who have conjunctival symptoms only may not show a positive result for Influenza A/H5 using an NP swab.
Special Instructions
If reflex test is performed, additional charges/CPT code(s) may apply.
Limitations
This test detects influenza A, influenza B and sequences for the H5 subtype. Non-H5 subtypes will not be detected in this assay. Influenza A/H5 is currently very rarely found in humans in the U.S. Results from this test must be correlated with the clinical history, epidemiological data and other data available to the clinician evaluating the patient. Viral and bacterial nucleic acids may persist in vivo independent of organism viability. Detection of organism target(s) does not imply that the corresponding organisms are infectious or are the causative agents for clinical symptoms. The detection of viral and bacterial nucleic acid is dependent upon proper specimen collection, handling, transportation, storage and preparation. Failure to observe proper procedures in any one of these steps can lead to incorrect results. There is a risk of false positive or false negative values resulting from improperly collected, transported or handled specimens.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Specimen Requirements
Specimen
Nasopharyngeal swab
Volume
1 swab
Minimum Volume
1 swab
Container
Universal or Viral Transport Media (UTM or VTM)
Collection Instructions
Collect NP swab per standard techniques and immediately place swab in up to 3 mL of universal or viral transport media.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 24 hours |
| Refrigerated | 72 hours (3 days) |
| Frozen | -70°C or lower = 14 days |
| Freeze/Thaw cycles | Stable x2 |
Storage Instructions
Freeze.
Causes for Rejection
Improper collection; inadequate specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen exceeding storage requirements; nasal swabs or any other upper respiratory sample other than nasopharyngeal swab in universal or viral transport media; samples submitted in non-approved transport devices
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 140046 | Flu A+B w/Rflx H5 subtype, NAA | 97733-0 | 140104 | Influenza A RNA | 76078-5 | |
| 140046 | Flu A+B w/Rflx H5 subtype, NAA | 97733-0 | 140106 | Influenza B RNA | 85478-6 | |
| 140046 | Flu A+B w/Rflx H5 subtype, NAA | 97733-0 | 140113 | FluA/H5 subtype Rflx | 38272-1 | |
| Order Code | 140046 | |||||
| Order Code Name | Flu A+B w/Rflx H5 subtype, NAA | |||||
| Order Loinc | 97733-0 | |||||
| Result Code | 140104 | |||||
| Result Code Name | Influenza A RNA | |||||
| UofM | ||||||
| Result LOINC | 76078-5 | |||||
| Order Code | 140046 | |||||
| Order Code Name | Flu A+B w/Rflx H5 subtype, NAA | |||||
| Order Loinc | 97733-0 | |||||
| Result Code | 140106 | |||||
| Result Code Name | Influenza B RNA | |||||
| UofM | ||||||
| Result LOINC | 85478-6 | |||||
| Order Code | 140046 | |||||
| Order Code Name | Flu A+B w/Rflx H5 subtype, NAA | |||||
| Order Loinc | 97733-0 | |||||
| Result Code | 140113 | |||||
| Result Code Name | FluA/H5 subtype Rflx | |||||
| UofM | ||||||
| Result LOINC | 38272-1 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 140038 | Influenza A/H5 subtyping, NAA | 140108 | Influenza A | 76078-5 | |
| Reflex 1 | ||||||
| Order Code | 140038 | |||||
| Order Name | Influenza A/H5 subtyping, NAA | |||||
| Result Code | 140108 | |||||
| Result Name | Influenza A | |||||
| UofM | ||||||
| Result LOINC | 76078-5 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 140038 | Influenza A/H5 subtyping, NAA | 140107 | H5 subtype | 38272-1 | |
| Reflex 1 | ||||||
| Order Code | 140038 | |||||
| Order Name | Influenza A/H5 subtyping, NAA | |||||
| Result Code | 140107 | |||||
| Result Name | H5 subtype | |||||
| UofM | ||||||
| Result LOINC | 38272-1 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 140038 | Influenza A/H5 subtyping, NAA | 140109 | Test Information | N/A | |
| Reflex 1 | ||||||
| Order Code | 140038 | |||||
| Order Name | Influenza A/H5 subtyping, NAA | |||||
| Result Code | 140109 | |||||
| Result Name | Test Information | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||