BakoDx SARS-CoV-2 + Influenza A/B Combo Test

BakoDx is receiving COVID-19 specimens and performing testing.

Patients

Healthcare Providers

BakoDx Laboratory Testing for COVID-19 Virus & Influenza A/B

BakoID™ COVID-19 and Influenza A/B is a Nucleic Acid Amplification Test (NAAT). The assay utilizes RT-PCR, providing accurate and timely test results. The test detects the presence of the 2019 coronavirus (SARS-CoV-2), influenza A and influenza B RNA in both nasal and nasopharyngeal swab samples. The tests may be ordered together or separate. This is a BakoDx laboratory-developed test (LDT), which is performed at a CLIA-certified laboratory and does not require US Food and Drug Administration (FDA) pre-approval.

Criteria for healthcare providers for the evaluation of patient testing for influenza and SARS-CoV-2 are available from the Centers for Disease Control and Prevention (CDC) at: https://www.cdc.gov/flu/professionals/diagnosis/index.htm. Healthcare providers should use their judgment to determine if a patient should be tested. Confirmation of influenza virus infection by diagnostic testing is not required for decisions to prescribe antiviral medication, according to the CDC.

COVID-19 Virus + Flu Test Information

BakoDx will provide specimen collection supplies as available. Facilities may also utilize their own supplies provided they meet the specifications outlined below.

Accepted Sample Collection

  • Nasal swab
  • Nasopharyngeal swab
  • Oropharyngeal swab (When ordering COVID-19 test only, not available for flu)

Accepted Swabs (in appropriate media)

  • Synthetic, flocked swabs

Swabs NOT Accepted

  • Dry swabs
  • Wood shaft swabs
  • Calcium-alginate tip swabs
  • Swabs with preservatives

Accepted Transport Media

  • Viral transport media (VTM), or sterile saline in 1mL or 3mL volume

View Illustrated Guides Here

Nasal Swab Instructions

  • Tilt patient’s head back 70 degrees.
  • Insert swab into 1 nostril straight back (not upwards, until resistance is met at turbinates).
  • Gently rotate it in a circular motion several times against nasal wall. Slowly remove swab while rotating it.
  • Repeat this step for the second nostril using the same swab.
  • Place tip of swab into 1-3 mL of sterile Transport Media tube. Bend/cut/snap the applicator stick as appropriate.

Nasopharyngeal (NP) Swab Instructions

  • Tilt patient’s head back 70 degrees.
  • Insert swab into nostril along the palate extending straight back until the posterior nasopharynx is reached (swab should reach depth equal to distance from nostrils to outer opening of ear).
  • Gently rotate it in a circular motion several times and keep it in place for 10 seconds.
  • Slowly remove swab while rotating it.
  • Repeat this step for the second nostril using the same swab.
  • Place tip of swab into 1-3 mL of sterile Transport Media tube. Bend/cut/snap the applicator stick as appropriate.

Oropharyngeal (OP) Swab Instructions (When ordering COVID-19 test only, not available for flu)

  • Insert swab into mouth to contact the posterior pharynx and tonsillar areas (avoid the tongue, teeth and gums).
  • Place tip of swab into 1-3 mL of sterile Transport Media tube. Bend/cut/snap the applicator stick as appropriate.

Be sure to secure the cap. Leaking containers will not be able to be processed.

  • Specimens can be stored at 2-8°C for testing within 72 hours of collection. Refrigerated specimens received outside of this 72 hour window cannot be processed. Specimens may also be frozen (-20° C).

  • Cold packs/pouches should be used if placing specimens in a lockbox for courier pick-up.

  • A BakoDx test requisition form must accompany each specimen.

  • Two patient identifiers are needed on the requisition and the specimen.

  • Label specimen on Transport Media tube and ensure cap on tube is tightly sealed to prevent leakage (Use a bar code or permanent marker for labeling).

  • SARS-CoV-2 samples should be packed according to International Air Transport Association (IATA) regulations and in compliance with regulations for UN3373 Biological Substance, Category B.

  • Causes for Rejection:

    – Incomplete requisition form

    – Specimens beyond the acceptable length of time from collection as listed above

    – Specimens not kept at appropriate temperature requirements

    – Specimen types other than those listed in the Sample Collection Accepted section

    – Leaking containers

  • Results are available within 24-36 hours of when the sample is received at the lab.
  • The most effective way to receive test results is to be set up with a BakoDx online portal account.
  • If EMR integration is required, our technical department can assist.

Detected

SARS-CoV-2 (COVID-19) Detected: A positive signal by qPCR indicating presence of both specified genetic markers confirming SARS-CoV-2 RNA in the clinical specimen.

Not Detected

SARS-CoV-2 (COVID-19) Not Detected: A negative signal by qPCR indicating SARS-CoV-2 RNA is not present in the clinical specimen. A negative test does not rule out the possibility of COVID-19 infection. Re-testing of patients with persistent symptoms of COVID-19 should be considered.

Inconclusive

Inconclusive: A positive signal by qPCR for only one of the two specified genetic markers for SARS-CoV-2 RNA in the clinical specimen. Test not able to confirm presence or absence of SARS-CoV-2 RNA in the clinical specimen. Re-testing of this patient is recommended.

Invalid

Invalid: A negative signal by qPCR for RP and negative results for N1 and N2 suggests that the sample was either poorly collected or degraded following collection. Re-testing of patients with persistent symptoms of COVID-19 should be considered with special attention to specimen collection and assurance of post collection refrigeration.

-OR-

Invalid: No qPCR signals for SARS-CoV-2 RNA and assay controls were detected. This may be due to inhibition of qPCR reaction by an interfering substance(s) in the sample submitted. Re-testing of this patient is recommended.

  • COVID Virus PCR Test: $100 / Test
  • Influenza A/B PCR Test: $96 / Test
  • COVID Virus + Influenza A/B Combo PCR Test: $143 / Test

Getting Started with BakoDx COVID-19 Testing

  • Complete and submit the form at the bottom of this page
  • Email us: COVID19Test@bakodx.com
  • Call us at: 1-855-422-5628

Other Resources

Request COVID-19 Virus Testing

If you are a healthcare provider or administrator of a healthcare facility and are interested in having testing provided by BakoDx, please provide your contact information below and someone will reach out to you soon.

    Disclaimer: BakoDx, as a partner to your practice, provides learning resources to help you better serve your patients. The information contained within this document should be used at a physician’s discretion. BakoDx assumes no liability for its content.

    COVID-19 Test Statements:

    • This test has not been FDA cleared or approved.

    • This test has been authorized by FDA under an EUA for use by authorized laboratories.

    • This test has been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens

    • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use

    of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1),

    unless the authorization is terminated or revoked sooner.

    • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up

    testing with a molecular diagnostic should be considered to rule out infection in these individuals.

    • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform

    infection status.

    • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63,

    OC43, or 229E.