BakoDx Coronavirus (COVID-19) SARS-CoV-2 Test

BakoDx is receiving COVID-19 specimens and performing testing.

Patients

Healthcare Providers

BakoDx Laboratory Testing for COVID-19 Virus

BakoDx developed a real-time reverse transcription polymerase chain reaction (RT-PCR) assay, providing accurate and timely test results. The test detects the presence of SARS-CoV-2 and is available pursuant to the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for diagnostic testing in CLIA certified laboratories.

Criteria for healthcare providers for the evaluation of patients under investigation of COVID-19 are available from the Centers for Disease Control and Prevention (CDC) at: http://cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html. Healthcare providers should use their judgment to determine if a patient should be tested.

COVID-19 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

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

  • Any universal transport media (UTM), 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

  • 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.
  • Reporting via fax is also available with phone calls for positive results.

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.

$100 / 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.