Meridian Bioscience™ Illumigene Mycoplasma Direct DNA Amplification Assay

Meridian Bioscience™ Illumigene Mycoplasma Direct DNA Amplification Assay is a qualitative in vitro diagnostic test for detection of Mycoplasma pneumoniae, DNA in human throat swabs obtained from patients suspected of having M. pneumoniae infection. Uses loop-mediated isothermal DNA amplification (LAMP) technology to target segment of the M. pneumoniae genome.

Supplier:  Meridian Bioscience™ 280250

Catalog No. 23-315-124

Description

illumigene kits were rebranded as Alethia. Product is identical only the name is different. No validation of Alethia is needed if currently using illumigene version. If discontinued illumigene kits are ordered the Alethia version will ship. New Number is  23029012

• Results in less than 1 hour
• Detects Mycoplasma pneumoniae on day 1 of symptoms
• Simple sample preparation from throat swabs
• High sensitivity and specificity
• 0.0% Invalid Rate
• Quicker initiation of appropriate patient care
• Expanded molecular menu
• No capital expense or service contract required
• Small footprint, easily adaptable to any laboratory

Specifications

• Certifications/Compliance: CE Marked, FDA Cleared
• Description: FDA Cleared
• Clia Complexity: Moderate
• Sensitivity: 96%
• Specificity: 0.977

• Content And Storage: 2°C to 27°C
• CE Marker: Yes
• Sample Type: Throat Swab
• Quantity: 50 Tests

Safety and Handling

ShelfLife : 18 Months