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The illumigene® Group A Streptococcus (Group A Strep) assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus) in throat swab specimens. The illumigene Group A Strep assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. Results from the illumigene Group A Strep assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections. illumigene Group A Strep 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® Group A Strep DNA Amplification Test Kit, the illumigene® Group A Strep External Control Kit and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene Group A Strep assay utilizes loop-mediated isothermal amplification (LAMP) technology to detect the presence of Streptococcus pyogenes (Group A beta-hemolytic Streptococus) in throat swab specimens. Each illumigene Group A Strep assay is completed using an illumigene Sample Preparation Apparatus II/Negative Control III containing Control material, an illumigene Group A Streptococcus Test Device and an illumigene Heat Treatment Tube. Samples are diluted in the illumigene Sample Preparation Apparatus II and dispensed into an illumigene Heat Treatment Tube. Target and Control DNA is made available for isothermal amplification via heat-treatment. DNA amplification occurs in the illumigene Test Device. The illumipro- 10heats each illumigene Group A Strep Test Device containing prepared sample and Control material, facilitating amplification of target DNA. When S. pyogenes is present in the throat swab specimen, a 206 base pair sequence of the S. pyogenes genome is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The absorbance characteristics of the reaction solutions at the assay Run Start (Signalwikal, S) and at the assay Run End (Signalman) S). The illumipro-10 calculates the change in light transmission between Run End and Run Start (S;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 volues ore 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 SyS, ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as 'NVALID'. Numerical values 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. The illumigene Group A Strep External Control Kit contains a Positive Control Reagent. The External Positive control Reagent is used in conjunction with the illumigene Sample Preparation Apparatus II/Negative Control III reagent included in the illumigene Group A Strep Kit as part of routine Quality Control testing. 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.