The eazyplex® PneumoBug expert is a qualitative in vitro diagnostic medical device for use in the detection of specific nucleic acid sequences of: Chlamydia pneumoniae, Mycoplasma pneumoniae and Legionella pneumophila from bronchoaveolar lavage fluid (BAL). broncheal secretion (BS) or tracheal secretion (TS) via the isothermal LAMP(Loop-mediated AMPlification)-Method.
The intended purpose of the test includes:
- Diagnosis (confirmatory assay to verify results of previous testing) and aid to diagnosis (providing additional information to assist in the determination or verification of a patient's clinical status, wherein the test is not the sole determinant) of all kinds of patients via testing of BAL, BS or TS.
Protective mechanisms to prevent the use of false test results:
- Performance of "inhibition control" with each sample prevents the use of false negative test results, due to the inhibition of the amplification reaction whilst simultaneously serving as reagent control.
- The test result is only displayed if the inhibition control is valid.
- As required, a test strip can be processed as negative/ contamination control by testing RALF without addition of sample material. In this case, only the inhibition control is allowed to create a positive signal