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The illumigene Mycoplasma Direct DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma Direct assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the illumigene Mycoplasma Direct DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the illumigene Mycoplasma Direct DNA Amplification Assay may be necessary.

The illumigene Molecular Diagnostic Test System is comprised of the illumigene® Mycoplasma Direct DNA Amplification Assay Test Kit, the illumigene Mycoplasma Direct External Controls Kit, and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene Mycoplasma Direct molecular assay utilizes loop-mediated amplification (LAMP) technology to detect Mycoplasma pneumoniae in throat swab specimens. The illumigene Mycoplasma Direct kit includes illumigene Sample Preparation Apparatus III (SMP PREP II), illumigene Mycoplasma Test Devices, and Heat Treatment Tubes. The throat swab is added directly to the SMP PREP II, which contains assay control buffer. Samples processed through SMP PREP II (sample/control mixture) are heat treated to make target and control DNA available for amplification. The heat-treated sample is added to the illumigene Mvcoplasma Test Device. The illumipro-10 heats each illumigene Mycoplasma Test Device containing prepared sample and control material, facilitating amplification of target DNA. When M. pneumoniae is present in the specimen, a 208 base pair (bp) sequence of the M. pneumoniae intracellular protease-like gene is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signal initial, S;) and at the assay Run End (Signal final, S;). The illumipro-10 calculates the change in light transmission between Run End and Run Start (S, :S, ) and compares the ratio to a fixed cut-off value for disposition of results. Fixed cut-off values for the TEST chamber are used to report sample results. TEST chamber Sy:S, ratios less than 82% are reported as 'POSITIVE'; TEST chamber S;.S; ratios greater than or equal to 82% are reported as 'NEGATIVE'. Numerical values are not reported. Fixed cut-off values for the CONTROL chamber are used to determine validity. CONTROL chamber S; S, ratios less than 90% are considered valid and allow for reporting of TEST chamber results (POSITIVE, NEGATIVE). CONTROL chamber S;& ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as 'INVALID'. More stringent cut-off criteria are applied to the CONTROL chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately. The illumigene Mycoplasma Direct External Control Kit contains a Positive Control reagent for use in routine Quality Control testing; the illumigene Sample Preparation Apparatus III reagent provided with the Mycoplasma Direct Kit serves as the External Negative Control reagents are provided to aid the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors.

The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA ampification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the illumigene Mycoplasma DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the illumigene Mycoplasma DNA Amplification Assay may be necessary. illumigene Mycoplasma is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA ampification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome.

The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the illumigene Mycoplasma DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the illumigene Mycoplasma DNA Amplification Assay may be necessary. illumigene Mycoplasma is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

The illumigene Molecular Diagnostic Test System is comprised of the illumigene® Mycoplasma DNA Amplification Assay Test Kit, the illumigene® Mycoplasma External Control Kit and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene Mycoplasma assay utilizes loop-mediated isothermal amplification (LAMP) technology to detect the presence of Mycoplasma pneumoniae in human respiratory specimens (throat and nasopharyngeal swab specimens), Each illumigene Mvcoplasma assay is completed using an illumicene Assay Control Reagent containing Control material, an illumigene Reaction Buffer, an illumigene Mycoplasma Test Device and microcentrifuge tubes. Respiratory specimens are combined with the illumigene Assay Control Reagent. The Speciment is manually extracted and purfied using a commercially available extraction kit (Qiagen, QlAamp® DSP DNA Mini Kit). Extracted DNA is heat-treated. Target and Control DNA are made available for isothermal amplification via heattreatment. The heat-treated Specimen/Control sample is added to the illumigene Reaction Buffer. DNA amplification occurs in the illumigene Test Device. The illumipro-10 heats each illumigene Mycoplasma Test Device containing prepared Sample and Control material. facilitating amplification of target DNA. When M. pneumoniae is present in the specimen, a 200 base pair sequence of the M. pneumoniae genome is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signalinia) S) and at the assay Run End (Signalmar, S). The illumipro-10™ calculates the ratio of the Run End (Signal final or S) reads with the Run Start (Signal Initial or S) reads and compares the ratio to an established cut-off value. The illumipro-10 performs this ratio calculation to both the TEST chamber and the CONTROL chamber. Fixed cut-off values for the CONTROL chamber are used to determine validity. CONTROL chamber S;S; ratios less than 90% are considered valid and allow for reporting of TEST chamber results (POSITIVE, NEGATIVE). CONTROL chamber S; S; ratios greater than or equal to 90% are considered invalid. Results are reported as 'INVALD': Test chamber results are not reported. More stringent cut-off criteria are applied to the Control chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately. Fixed cut-off values for the TEST chamber are used to report sample results. TEST chamber Sy:S ratios less than 82% are reported as 'POSITIVE'; TEST chamber S;S; ratios greater than or equal to 82% are reported as 'NEGATIVE'. Numerical values are not reported. The illumigene Mycoplasma External Controls Kit contains a Positive Control Reagent, External Control reagents are provided to aid the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. External Control reagents are provided for use in routine Quality Control testing. ## illumipro-10™ Automated Isothermal Amplification and Detection System: The illumipro-10™ heats each illumigene Mycoplasma Test Device containing prepared samples and Control Reagent, facilitating amplification of target DNA. When Mvcoplasma pneumoniae is present in the respiratory swab sample, a conserved sequence of the M. pneumoniae is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 detects the change in light transmission through the reaction mixture created by the precipitating magnesium pyrophosphate. The illumipro-10 reports sample results as INVALID, POSITIVE or NEGATIVE based on the detected change in light transmission. The illumipro-10™ System Description was reviewed in previous submission. K10012. K112125. K121044 and K122019. No system or software changes were made for the illumigene Mycoplasma assay.