Joint Infection (JI) Panel PCR (Qualitative)

​To assist in identifying the etiological agent(s) of septic arthritis, by simultaneous detection of 31 common pathogens including bacteria and yeasts, as well as 8 antibiotic-resistance genes. It is intended to be used in conjunction with clinical history, signs and symptoms, and results of other diagnostic tests, including culture and anti-microbial susceptibility testing.

​Minimum volume of 0.5mL joint/synovial fluid to be aseptically collected in a leak-proof sterile container. Tissue, fluid from non-sterile sites and fluid not collected aseptically will be rejected.

Refrigerate sample at 2-8°C until transfer to laboratory. Do not freeze.

Send sample at 2-8°C. Sample should reach the laboratory as soon as possible preferably within 24 hours after collection.

Refrigerated samples may be stored for up to approximately 7 days.

Biofire® FilmArray^TM Joint Infection (JI) panel (BioMerieux)

​Detected, Not Detected, Not Applicable or Inconclusive

​1-2 working days

​Mondays to Saturdays (except public holidays)

Performance Characteristics:

Analytical Sensitivity (manufacturer's claim):

Gram Positive Bacteria

Anaerococcus prevotii/vaginalis: 4.8x10⁴ copies/mL

Clostridium perfringens: 1.3x10³ copies/mL

Cutibacterium avidum/granulosum: 5.0x10⁴ copies/mL

Enterococcus faecalis (vanA/B): 5.0x10³ copies/mL

Enterococcus faecium (vanA/B): 1.2x10³ copies/mL

Finegoldia magna: 3.1x10⁵ copies/mL

Parvimonas micra: 4.8x10³ copies/mL

Peptoniphilus: 4.0x10⁴ copies/mL

Peptostreptococcus anaerobius: 1.6x10⁴ copies/mL

Staphylococcus aureus (mecA/C and MREJ (MRSA)): 4.2x10³ copies/mL

Staphylococcus lugdunensis: 2.6x10³ copies/mL

Streptococcus spp.: 2.5x10⁵ copies/mL

Streptococcus agalactiae: 1.9x10⁴ copies/mL

Streptococcus pneumoniae: 5.3x10² copies/mL

Streptococcus pyogenes: 8.9x10³ copies/mL

Gram Negative Bacteria

Bacteroides fragilis: 1.1x10³ copies/mL

Citrobacter: 4.7x10³ copies/mL

Enterobacter cloacae complex (VIM): 1.3x10⁵ copies/mL

Escherichia coli (NDM): 6.0x10³ copies/mL

Haemophilus influenzae: 6.9x10² copies/mL

Kingella kingae: 3.4x10³ copies/mL

Klebsiella aerogenes (OXA-48-like): 7.5x10³ copies/mL

Klebsiella pneumoniae group (KPC): 1.6x10⁴ copies/mL

Morganella morganii: 2.2x10³ copies/mL

Neisseria gonorrhoeae: 2.2x10³ copies/mL

Proteus spp.: 5.2x10³ copies/mL

Pseudomonas aeruginosa (IMP): 1.3x10⁴ copies/mL

Salmonella spp. (CTX-M): 1.6x10³ copies/mL

Serratia marcescens: 1.1x10⁴ copies/mL

Yeast

Candida: 1.0x10³ copies/mL

Candida albicans: 5.0x10² copies/mL

​Analytical Specificity (manufacturer's claim):

Based on testing and in silico analysis on species and AMR genes that are genetically related to the species or AMR genes detected by the panel as well as unrelated organisms that may be found in synovial fluid as pathogens or contaminants (e.g. skin microorganisms, viruses, etc.), all observed and predicted cross-reactivities are associated with very closely-related species (same genus) or AMR genes derived from similar lineages.

For gram-positive bacteria, each of the assays is specific for detection of the indicated species with the exception of cross-reactivity with some rare near-neighbour species of Anaerococcus (multiple species), Clostridium (C. baratii, C. cadaveris, C. disporicum, C. fallax, and C. grantii), and species of the S. aureus complex (S. argenteus and S. schweitzeri).

For gram-negative bacteria, the assays are specific for detection of the indicated genus, complex, group or species, with the exception of the cross-reactivities with closely-related species described below:

• Bacteroides xylanisolvens, a commensal species that naturally resides in the human intestine, can be mis-identified as Bacteroides fragilis due to non-specific interaction with the Bfragilis assay.
  
• The Enterobacter cloacae complex (ECC) is comprised of multiple species that may all be identified as E. cloacae by phenotypic laboratory methods. The Ecloacae assay will detect species and subspecies within the complex and may also react with other genetically related species e.g. E. bugandensis and E. chengduensis, that have been more recently identified and may not be consistently designated as species of the ECC.
• The Ecoli assay cross-reacts with Shigella species (S. boydii, S. dysenteriae, S. flexneri, and S. sonnei); which are practically indistinguishable from E. coli by both phenotypic and genetic analyses but are not generally associated with JI. Cross-reactivity has also been observed with Escherichia fergusonii, a rare but emerging veterinary and human pathogen, and Escherichia albertii (only at high concentration), a species more typically associated with gastrointestinal infections.
• Haemophilus aegyptius, a species formerly described as a subgroup or biotype of Haemophilus influenzae, is difficult to differentiate from H. influenzae by most laboratory methods and will be detected as Haemophilus influenzae by the BioFire JI Panel due to cross-reactivity.
• Kingella negevensis, a recently identified species linked to pediatric joint infections and that is closely related to, and likely to be mis-identified by standard laboratory methods as, K. kingae will also be detected as Kingella kingae by the BioFire JI Panel due to cross-reactivity.
• The Proteus assay can cross-react with an insect-associated species (Consenzaea myxofaciens) that was formerly classified as Proteus myxofaciens.