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Respiratory Pathogen Plus Antibiotic Resistance Panel

St. Jude Labs
SKU: SJL0018

$487.50 per test

The Respiratory Pathogen Panel with Antibiotic Resistance detects viral and bacterial pathogens known to cause respiratory infections, including the flu and COVID-19, and identifies markers of antibiotic resistance for a given infection.  

The Respiratory Pathogen Panel with Antibiotic Resistance detects viral and bacterial pathogens known to cause respiratory infections, including the flu and COVID-19, and identifies markers of antibiotic resistance for a given infection.  

The Fine Print

Purpose: Detects viral and bacterial respiratory pathogens and associated antibiotic resistance markers that may be present.

By using molecular diagnostics, the Respiratory Pathogen Panel plus Antibiotic Resistance Markers can identify respiratory pathogens and antibiotic resistance markers rapidly, allowing for the gathering of therapy-relevant molecular information so the correct medication can be given to combat infection.

Benefits:

  • Discover if an infectious cause of respiratory difficulties is present.
  • Help in developing treatment plan if respiratory pathogens are 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 Detected:

This respiratory pathogen panel seeks to evaluate common viral, bacterial, and fungal causes of a respiratory infection.  

It will test for the following:

  • Viral Targets:
    • Bocavirus
    • Coronavirus 229E
    • Coronavirus HKU1
    • Coronavirus NL63
    • Coronavirus OC43
    • Human Metapneumovirus A & B
    • Human Rhinovirus
    • Human Enterovirus
    • Influenza A-c
    • Influenza A/H1-20G9
    • Parainfluenza virus,  Type 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

This test can identify the following antibiotic resistance markers:

  • Temoniera-β-lactamase (TEM)
  • Sulfhydryl Variable-β-lactamase  (SHV)
  • Klebsiella pneumoniae carbapenemase (KPC)
  • CefoTaXime-M-β-lactamase (CTXM 1)
  • CefoTaXime-M-β-lactamase (CTXM 2)
  • CefoTaXime-M-β-lactamase (CTXM 8)
  • CefoTaXime-M-β-lactamase (CTXM 9)
  • CefoTaXime-M-β-lactamase (CTXM 25)
  • New Delhi metallo-β-lactamase (NDM)
  • Verona integron-encoded metallo-β-lactamase (VIM)
  • Verona integron-encoded metallo-β-lactamase (VIM 7)
  • Verona integron-encoded metallo-β-lactamase (VIM 13)
  • Cephamycinase (CMY 1)
  • Cephamycinase (CMY 2)
  • Cefoxitin-Hydrolyzing Class C-β-lactamase (FOX)
  • Oxacillinase Group (OXA 1)
  • Oxacillinase Group (OXA 2)
  • Oxacillinase Group (OXA 48)
  • Methicillin Resistance (mecA)
  • Sulfonamide-Resistant isolate (Sul 1)
  • Sulfonamide-Resistant isolate (Sul 2)
  • Sulfonamide-Resistant isolate (Sul 3)
  • Erythromycin Resistance Gene (ermB)
  • Plasmid-Mediated Quinolone Resistance Determinant (qnrA 1)
  • Plasmid-Mediated Quinolone Resistance Determinant (qnrB 1)
  • Plasmid-Mediated Quinolone Resistance Determinant (qnrB 5)
  • Plasmid-Mediated Quinolone Resistance Determinant (qnrS)
  • Vancomycin Resistance (Van A)
  • Vancomycin Resistance (Van B)
  • Vancomycin Resistance (VanC 1)
  • Vancomycin Resistance (VanC 2-4)

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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