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Respiratory Pathogen Panel

St. Jude Labs
SKU: SJL0019

$437.50 per test

The Respiratory Pathogen Panel detects viral and bacterial pathogens known to cause respiratory infections, including the flu and COVID-19, using molecular diagnostics with a quick turnaround time.

The Respiratory Pathogen Panel detects viral and bacterial pathogens known to cause respiratory infections, including the flu and COVID-19, using molecular diagnostics with a quick turnaround time.

The Fine Print

Purpose: This Respiratory Pathogen Panel seeks to evaluate common viral, bacterial, and fungal causes of a respiratory infection using molecular diagnostics.

Benefits:

  • Discover if an infectious cause of respiratory difficulties is present.
  • High accuracy (99.9%) and speed of Molecular testing

Sample type: Nasopharyngeal swab

Technology: Molecular PCR testing

Turnaround time: 2-3 days from receipt in lab

What will be in my kit?

Instructions, Biohazard Bag, Swab with collection tube, pre-paid return envelope

Pathogens Tested For:

Viral Targets:

  • A/B Adenovirus
  • Bocavirus
  • Coronavirus 229E
  • Coronavirus HKU1
  • Coronavirus NL63
  • Coronavirus OC43
  • Human Metapneumovirus A & B
  • Human Rhinovirus
  • Human Enterovirus
  • Influenza A, B, C
  • Influenza A/H1-20G9
  • Parainfluenza Virus, 1, 2, 3, 4
  • Parechovirus
  • Respiratory Syncytial Virus

Bacterial Targets:

  • Mycoplasma pneumoniae
  • Chlamydia pneumoniae
  • Streptococcus pneumoniae
  • Klebsiella pneumoniae
  • Legionella
  • Haemophilus influenzae B
  • Staphylococcus aureus (reflex to MRSA)
  • Salmonella spp.
  • Moraxella catarrhalis
  • Bordetella spp.

Fungal Targets:

  • Pneumocystic jirovecii

What is a CLIA certified laboratory?

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. (Accessible at: https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia).

Is this test FDA approved?

Laboratory Developed Tests (LDT) do not require FDA approval if they are developed using CLIA policies.  This test is analytically validated in accordance with the CLIA Guidance Document (Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing) as a Laboratory Developed Test (LDT) by St Jude Laboratories, LLC.  Therefore, it has not been cleared or approved by the FDA.

NOTE: This test cannot be offered in the state of New York, USA.

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