SARS-CoV-2 and Influenza A&B PCR by Roche LIAT

IFCVD

CoV2 (COVID-19) and FLU A/B, Rapid, Qualitative; SARS-CoV-2 and Flu A/B PCR Qual NAAT

Sterile nasopharyngeal swabs, in approved UTM/VTM (Viral Transport media)

1 swab

1. Follow AHC personal protective policy, gown, glove, and use face protection when collecting specimen.
2. Collect Nasopharyngeal Swab 

• Gently insert the swab into the nostril. Keep the swab near the septum floor of the nose while gently pushing the swab into the post nasopharynx
• As a visual reference, the swab should be inserted about half the distance from the opening of the patient’s nostril and the ear. Rotate the swab several times.

3. Place the swab in Universal Transport Medium (UTM, red top). Break the swab shaft at the score-line against the side of the tube. Note: the swab can alternatively be placed in Viral Culture Media (VCM, green top) for transport.
4. Label specimen per hospital policy.
5. Hand deliver the sample to the lab.

Universal Transport Medium (UTM) from Copan Diagnostics; P/N 305C
OR
BD Universal Viral Transport (UVT) 3-mL collection kit with a flocked flexible minitip swab; P/N 220531

Room temperature: 4 hours; Refrigerated: 72 hours

• Specimens containing calcium alginate swabs, cotton swabs with wooden shaft.
• Dry Swabs, Swabs transported without UTM/VTM
• Specimens exceeding stability
• Specimens from leaking, uncapped or broken container

• Detection of SARS-CoV-2 RNA may be affected by sample collection methods, patient factors (e.g., presence of symptoms), and/or stage of infection.
• As with other tests, negative results do not preclude SARS-CoV-2, Influenza A or Influenza B, infection and should not be used as the sole basis for treatment or other patient management decisions.
• False negative results may occur if a specimen is improperly collected, transported or handled, if there is insufficient RNA to be detected, or if one or more target viruses inhibits amplification of other targets.
• Invalid results may be obtained if there is insufficient sample volume or if the specimen contains inhibitory substances that prevent nucleic acid target extraction and/or amplification and detection.
• False negative or invalid results may occur due to interference. The Internal Control is included in cobas® Liat® SARS-CoV-2 to help identify the specimens containing substances that may interfere with nucleic acid isolation and PCR amplification. These samples will result as Invalid.

Not detected

The Roche LIAT SARS-CoV-2 & Influenza A/B test is intended for use in the simultaneous rapid in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus nucleic acids in clinical specimens and is not intended to detect influenza C virus. SARS-CoV-2, influenza A and influenza B viral RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease.
 
Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.