ROCKVILLE, Md., Jan. 22, 2018 /PRNewswire/ — Healthcare-associated (or hospitalacquired infections), HAIs, are illnesses that are most commonly acquired in hospital settings. The infectious are a serious problem for global healthcare systems, but prevention, and to some degree, IVD testing is combating infections.  This is according to the recent Kalorama Information report, The Prevention Effect on HAI Markets.

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Those that are frequently encountered include bloodstream infections, pneumonias, urinary tract infections, surgical site infections, and gastroenterological conditions. Staphylococcus aureus, one of the most common nosocomial pathogens, causes skin lesions and could even lead to necrotizing fasciitis.  The bloodstream infections increase risk of developing sepsis, another major problem that hospitals face.

The most common attributes among HAI pathogens are, of course, the environment in which they are most commonly encountered and risk factors of contracting their infections. They are most commonly associated with invasive devices like IV and urinary catheters, tracheotomy tubes, and ventilators, with open wounds, surgical sites, and other areas of trauma like severe burns, or with immunosuppressant treatment administered to patients with organ and tissue transplants. As is usually the case, the very young, the elderly, and those with compromised immunity are at highest risk, as are diabetic patients, and women who have recently given birth or experienced a miscarriage. 

The following developments in point-of-care are designed to help healthcare systems detect infectious disease. 

  • The GenomEra CDX system, produced by Abacus Diagnostica Oy, is found more often in hospitals than in POC sites because the system’s assays are so directed for HAI and sepsis testing. The platform has a whole host of tests designed for the detection of such pathogens, including norovirus, difficile, and S. pneumoniæ; there are multiple diagnostics for methicillin-resistant S. aureus (MRSA) alone, with variants for nasal swab, culture plate, blood culture, and multiple site swab.
  • Becton Dickinson’s BD MAX is designed to compete in the HAI testing market, with assays available for difficileCampylobacter, enteroinvasive E. coli (EIEC), norovirus, rotavirus, Salmonella, and three MRSA assays. BD is currently developing a panel for carbepenem-resistant organisms, and produces a research use only (RUO) assay for carbepenem-resistant Enterobacteriaceæ(CRE).
  • The BioFire FilmArray by bioMérieux has multiplex diagnostic panels for gastrointestinal and bloodstream infections. The former detects difficileCampylobacter, norovirus, rotavirus, and Salmonella; the latter targets AcinetobacterCandida species, Enterococcus, P. æruginosa, S. aureus, as well as genes that confer drug resistance.
  • Installations of Cepheid’s GeneXpert system have been driven in part by the company’s pathogen-testing applications, especially for MRSA and difficile. Cepheid released an updated version of the MRSA assay (MRSA NxG) that can perform MRSA surveillance testing in 45 minutes. Additional assays include norovirus, carbapenem resistance genes, vancomycin resistance in Enterococcus, and an assay that targets the HAI-specific C.difficile Epidemic 027 strain.
  • Coris Bioconcept produces immunochromatographic dipsticks and cassettes for pathogens including difficile and rotavirus, and qPCR kits for genes (mexA and mexX) that encode proteins for efflux pumps in P. æruginosa.
  • The LiDiA diagnostic platform by DNA Electronics, slated for launch this year, is dedicated primarily to sepsis and HAI pathology, with the first cartridge-based test designed to detect bacterial and fungal infections associated with bloodstream infections; DNAe anticipates LiDiA to be placed principally in hospitals.
  • DxNA produces an S. aureus test for its CE-marked, cartridge-based GeneSTAT, that detects strains both resistant and sensitive to methicillin.
  • Greiner Bio-One’s Genspeed R2 is dedicated entirely to nosocomial infections, with four CE-IVD tests on the market. Genspeed MRSA detects not only aureus, but also S. epidermidis and S. hæmolyticus, as well as mecA and mecC genes. Genspeed C. diff OneStep detects the C. difficile GDH antigen as well as the entero-, cyto- and binary toxins the bacteria produce. Genspeed Superbug targets over 70 carbepenemase variants, and Genspeed VanABC Plus is a single-tube multiplex assay for transmissible and non-transmissible vancomycin resistance genes.
  • iCubate produces RUO assays including a Gram-positive Bacteria cassette that detects many HAI-associated pathogens, as well as a fully purpose-built HAI cassette that targets baumanniiEscherichia coliE. fæcalisE. fæciumEnterobacter cloacæP. æruginosaProteus mirabilisS. aureus, five Candida species, and detects methicillin resistance.
  • Nanosphere’s Verigene system detects nucleic acids and proteins from numerous HAI-associated pathogens in Gram-positive and -negative, Enteric pathogen, and C. difficile tests. Targets include Campylobacter, Enterobacter, Escherichia, Klebsiella, Pseudomonas, Salmonella, Shigella, Staphylococcus, Streptococcus, and Vibrio species, among many others.
  • Users of Oxford Nanopore’s MinION have used the diminutive sequencing platform for clinical research or surveillance of æruginosa strains, sequencing Salmonella from an outbreak at a UK hospital, and rapid drug resistance detection in S. aureus.

Kalorama Information’s latest report on this topic is The Prevention Effect on HAI Markets, which is available at:

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