2nd Generation Real-Time PCR MRSA Kit to Detect mecALGA251 Gene.
ELITech Molecular Diagnostics launches a second generation CE-IVD test, MRSA/SA ELITe MGB®* Kit, a new multiplex, qualitative Real-Time PCR assay for the direct detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from human nasal swab specimens. The second generation test incorporates all the design advantages of the original test, plus detection of the recently identified mecALGA251 variant. The first generation MRSA/SA ELITe MGB® Kit was originally designed to more accurately detect MRSA infections; generating from 27% to 50% fewer missed MRSA infections when compared to published values of competing amplification methods, and 3 times fewer missed MRSA when compared to culture (1,2).
The mecALGA251 homologue is a clinically important MRSA variant that may be present in as many as 4 to 6% of all MRSA infections (3,4). These studies have also shown that mecALGA251 shares only 70% (5) nucleotide homology with the conventional MRSA gene nucleic acid targets, increasing the likelihood that current MRSA molecular tests may not detect this variant. In preliminary studies, the second generation MRSA/SA Elite MGB® Kit had a sensitivity of 100% and a specificity of 97.5% for MRSA.
Pierre Debiais, President and CEO of the ELITech Group, states "We are very pleased to introduce our second generation MRSA/SA ELITe MGB® Kit, the first MRSA test to detect the mecALGA251 gene, a clinically important MRSA variant. The unique design of the MRSA/SA ELITe MGB® Kit confers outstanding detection performance and addresses a critical unmet need for clinicians and healthcare providers. ELITech's MRSA/SA ELITe MGB® Kit, with our exclusive MGB Technology, provides an important new tool that will help clinicians effectively detect MRSA and Staphylococcus aureus and guide patient care."
(1) Clinical data values for this analysis excerpted from the ''Expected Results'' section of each manufacturers' package insert.
(2) Based on results published and summarized in "The impact of incorrect MRSA diagnoses", MLO, January 2012, pp 26-27.
(3) ECCMID 2012, Poster P1317. Nationwide survey of methicillin-resistant Staphylococcus aureus harbouring mecALGA251(mecC) reveals a reservoir in ruminants (Larsen et al.)
(4) Clin Microbiol Infect. 2012 Apr; 18(4):395-400. Rapid detection, differentiation and typing of methicillin-resistant Staphylococcus aureus harbouring either mecA or the new mecA homologue mecALGA251 (Stegger et al.)
(5) Lancet Infect Dis. 2011 Aug; 11(8):595-603. Methicillin-resistant Staphylococcus aureus with a novel mecA homologue in human and bovine populations in the UK and Denmark: a descriptive study (Garcia-Alvarez et al.)
Date Published: 16th July 2012
Emeryville Pharmaceutical Services Launches Microbiological
Poultry Boot Swab Kit