Meridian Bioscience™ Alethia™ Mycoplasma Direct DNA Amplification Assay

Description

Qualitative in vitro diagnostic test for detection of Mycoplasma pneumoniae, DNA in human throat swabs. Uses loop-mediated isothermal DNA amplification (LAMP) to target segment of the M. pneumoniae genome

• 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

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Specifications

• Certifications/Compliance: CE Marked, FDA Cleared
• Content And Storage: 2°C to 27°C
• Description: FDA Cleared
• CE Marker: Yes
• Clia Complexity: Moderate
• Sample Type: Throat Swab
• Sensitivity: 96%
• Quantity: 50 Tests
• Specificity: 0.977