For Inpatient and Outpatient testing of SARS COV2, and for repeat testing after a negavtive FLUCV or RP2.
EPIC Test Code
LAB4147
Methodology
SARS-Cov-2 NAA assays are performed on two different platforms. RT-PCR tests are manufactured by BDMax and Cepheid. Utilization of multiple platforms ensures continuity and availability of testing. The BD Max assay is cleared for use under the FDA Emergency Use Authorization. The Cepheid assay is FDA 510(k) cleared.
One nasopharyngeal swab in 3 mL viral transport media (UTM, VTM).
Unacceptable Conditions
Specimens received outside of stated stability limits. Dry swabs not in listed transport media. Alternate specimen sources/transport that are not validated with this assay will not be tested. Specimen from patients that don’t meet the testing requirements. Frozen samples. For guidance please contact Salem Health Infection Prevention at 503-814-2788.
One nasopharyngeal swab in 3 mL viral transport media (UTM, VTM).
Unacceptable Conditions
Specimens received outside of stated stability limits. Dry swabs not in listed transport media. Alternate specimen sources/transport that are not validated with this assay will not be tested. Specimen from patients that don’t meet the testing requirements. Frozen samples. For guidance please contact Salem Health Infection Prevention at 503-814-2788.
Proper Specimen and Collections: Nasopharyngeal Swab
Standard Volume
One nasopharyngeal swab in 3 mL viral transport media (UTM, VTM).
Unacceptable Conditions
Specimens received outside of stated stability limits. Dry swabs not in listed transport media. Alternate specimen sources/transport that are not validated with this assay will not be tested. Specimen from patients that don’t meet the testing requirements. Frozen samples. For guidance please contact Salem Health Infection Prevention at 503-814-2788.
For Inpatient and Outpatient testing of SARS COV2, and for repeat testing after a negavtive FLUCV or RP2.
Methodology
SARS-Cov-2 NAA assays are performed on two different platforms. RT-PCR tests are manufactured by BDMax and Cepheid. Utilization of multiple platforms ensures continuity and availability of testing. The BD Max assay is cleared for use under the FDA Emergency Use Authorization. The Cepheid assay is FDA 510(k) cleared.
Inpatient and Employee testing: Within 24 hrs. (Most results within 12 hours) Outpatient testing: 24-48 hrs.
Unacceptable Conditions
Specimens received outside of stated stability limits. Dry swabs not in listed transport media. Alternate specimen sources/transport that are not validated with this assay will not be tested. Specimen from patients that don’t meet the testing requirements. Frozen samples. For guidance please contact Salem Health Infection Prevention at 503-814-2788.
Reference Interval
Negative
Negative results do not preclude SARS-CoV-2 infection since the adequacy of sample collection and/or viral load may result in the presence of viral nucleic acids below the analytical sensitivity of this test. A negative result should not be used as the sole basis for treatment or other patient management decisions.
Interpretive Data
Presumptive Positive test results have been repeated for verification. SARS-CoV-2 nucleic acids may be present. Additional confirmatory testing may be conducted if it is necessary to differentiate between SARS-CoV-S and SARS-CoV-1 or other Sarbecovirus currently unknown to infect humans, for epidemiological purposes or clinical management. Confirmatory testing can be sent to LabCorp (COVID) as an add on test per provider request.
For Inpatient and Outpatient testing of SARS COV2, and for repeat testing after a negavtive FLUCV or RP2.
EPIC Test Code
LAB4147
Methodology
SARS-Cov-2 NAA assays are performed on two different platforms. RT-PCR tests are manufactured by BDMax and Cepheid. Utilization of multiple platforms ensures continuity and availability of testing. The BD Max assay is cleared for use under the FDA Emergency Use Authorization. The Cepheid assay is FDA 510(k) cleared.
One nasopharyngeal swab in 3 mL viral transport media (UTM, VTM).
Unacceptable Conditions
Specimens received outside of stated stability limits. Dry swabs not in listed transport media. Alternate specimen sources/transport that are not validated with this assay will not be tested. Specimen from patients that don’t meet the testing requirements. Frozen samples. For guidance please contact Salem Health Infection Prevention at 503-814-2788.
One nasopharyngeal swab in 3 mL viral transport media (UTM, VTM).
Unacceptable Conditions
Specimens received outside of stated stability limits. Dry swabs not in listed transport media. Alternate specimen sources/transport that are not validated with this assay will not be tested. Specimen from patients that don’t meet the testing requirements. Frozen samples. For guidance please contact Salem Health Infection Prevention at 503-814-2788.
Proper Specimen and Collections: Nasopharyngeal Swab
Standard Volume
One nasopharyngeal swab in 3 mL viral transport media (UTM, VTM).
Unacceptable Conditions
Specimens received outside of stated stability limits. Dry swabs not in listed transport media. Alternate specimen sources/transport that are not validated with this assay will not be tested. Specimen from patients that don’t meet the testing requirements. Frozen samples. For guidance please contact Salem Health Infection Prevention at 503-814-2788.
For Inpatient and Outpatient testing of SARS COV2, and for repeat testing after a negavtive FLUCV or RP2.
Methodology
SARS-Cov-2 NAA assays are performed on two different platforms. RT-PCR tests are manufactured by BDMax and Cepheid. Utilization of multiple platforms ensures continuity and availability of testing. The BD Max assay is cleared for use under the FDA Emergency Use Authorization. The Cepheid assay is FDA 510(k) cleared.
Inpatient and Employee testing: Within 24 hrs. (Most results within 12 hours) Outpatient testing: 24-48 hrs.
Unacceptable Conditions
Specimens received outside of stated stability limits. Dry swabs not in listed transport media. Alternate specimen sources/transport that are not validated with this assay will not be tested. Specimen from patients that don’t meet the testing requirements. Frozen samples. For guidance please contact Salem Health Infection Prevention at 503-814-2788.
Reference Interval
Negative
Negative results do not preclude SARS-CoV-2 infection since the adequacy of sample collection and/or viral load may result in the presence of viral nucleic acids below the analytical sensitivity of this test. A negative result should not be used as the sole basis for treatment or other patient management decisions.
Interpretive Data
Presumptive Positive test results have been repeated for verification. SARS-CoV-2 nucleic acids may be present. Additional confirmatory testing may be conducted if it is necessary to differentiate between SARS-CoV-S and SARS-CoV-1 or other Sarbecovirus currently unknown to infect humans, for epidemiological purposes or clinical management. Confirmatory testing can be sent to LabCorp (COVID) as an add on test per provider request.
