COVID-19, Flu A/B, RSV, PCR

CPT: 87801

  • Aid in the differential identification of COVID-19, Influenza A, Influenza B, and Respiratory Syncytial Virus (Type A and B) by nucleic acid amplification

    Methodology

    Multiplex real-time PCR (RT-PCR)

    Reference Interval

    Not detected

    Limitations

    Not Detected (Negative) results do not preclude an infection and should not be used as the sole basis for treatment or other patient management decisions. Not Detected (Negative) results must be combined with clinical observations, patient history and other clinical information.

    Detected (POSITIVE) results are indicative of possible active infection but do not rule out fungal infection or co-infection with other bacteria.

    The pathogen(s) detected may not be the definite cause of disease. A positive (Detected) test result may be observed after successful antibiotic treatment due to target nucleic acid from residual not viable organism(s).

    DISCLAIMER:

    The assays in the molecular panel are not 510K cleared, but managed by CMS and FDA under the Clinical Laboratory Improvement Amendment (CLIA) as a laboratory developed test (LDT). The analytical performance characteristics of these assays have been determined by FutureGeneration Laboratories. The assays have been validated pursuant to the CLIA regulations and are used for Clinical Diagnostic Purposes.

    • Insurance

    • If insurance is not billed, patients are responsible for the cost for testing - $200.

  • 1-3 days

    Turnaround time is defined as the usual number of days from the date of receipt of a specimen to the laboratory. Testing schedules may vary.

  • Submit one specimen per specimen source on tests requested

    Collection

    All providers must follow the provided collection and processing instructions. These instructions are adopted in FutureGeneration Laboratories’ established policies and procedures – including patient and specimen identification, processing, storage and rejection.

    Note: Specimen collection is not conducted at FutureGeneration Laboratories. Clinical specimens are only processed and tested by the laboratory.

    ­Collection of Nasopharyngeal Swab (Test: COVID-19, Flu A/B, RSV)

    1. Tilt the patient’s head back 70 degrees.

    2. Insert the swab into the nostril (the swab should reach depth equal to the distance from nostril to outer opening of the ear). Allow the swab to absorb secretion for several seconds.

    3. Rotate the swab 5 times.

    4. Remove the swab and place the swab into liquid Amies media.

    Collection of the Mid-Turbinate Swab (Test: COVID-19, Flu A/B, RSV)

    1. Tilt the patient’s head back and gently insert the swab into the nytril.

    2. Using a gentle rotation, push the swab until slight resistance is met at the level of turbinate.

    3. Rotate the swab 5 times against the nasal wall.

    4. Remove the swab and place the swab into liquid Amies media.

    Volume

    3 mL

    StorageRequirements

    Maintain specimen at 15°C to 30°C up to 3 days.

    Rejection Criteria

    The following samples will be unacceptable for testing and will be rejected: 

    1. Specimen is unlabeled or improperly labeled. Properly labeled includes two patient identifiers matching submitted requisition form.

    2. Requisition form is missing or incomplete.

    3. Specimen is improperly sealed, resulting in leakage and possible contamination during transport.

    4. Incorrect specimen type (i.e. non-clean catch sample).

    5. Insufficient sample volume for testing.

    6. Urine specimens submitted in Aptima buffer or other container with no bacteriostatic preservative.

    7. Specimens received after 3 days post-collection.

    8. Co-mingled samples.

    9. If the laboratory received a specimen and the reason for rejection cannot be resolved, the provider will receive a rejection report.

  • None