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The Liat™ Strep A Assay, performed on the Liat™ Analyzer, is a qualitative in vitro diagnostic test for the detection of Streptococus pyogenes (Group A 8-hemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis. The Liat™ Strep A Assay utilizes nucleic acid purification and polymerase chain reaction (PCR) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome.

The Liat™ Strep A Assay, performed on the Liat™ Analyzer, is a rapid, automated in vitro diagnostic test for the qualitative detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus, Strep A) DNA in throat swab specimens in Amies medium. The Liat™ Strep A Assay targets a well-conserved region of Strep A genome. An Internal Process Control (IPC) is also included. The IPC is present to control for adequate processing of the target bacteria through all steps of the assay process and to monitor the presence of inhibitors in the sample preparation and PCR. The sample-to-result time is ~15 minutes. The assay utilizes a single-use disposable Liat™ Tube that holds the sample purification and PCR reagents, and hosts the sample preparation and PCR processes. The Liat™ Tube contains all required unit dose reagents pre-packed in tube segments, separated by peelable seals, in the order of reagent use. The Liat™ Analyzer automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples. The Liat™ Analyzer performs all assay steps from clinical sample and reports assay result automatically. During the testing process, multiple sample processing actuators of the analyzer compress the Liat™ Tube to selectively release reagents from tube segments, move the sample from one segment to another, and control reaction volume, temperature, and time to conduct sample preparation, nucleic acid extraction, target enrichment, inhibitor removal, nucleic acid elution and real-time PCR. An embedded microprocessor controls and coordinates the actions of these sample processors to perform all required assay processes within the closed Liat™ Tube. Positive and negative controls are provided in the Liat™ Strep A Assay Quality Control Kit. The positive control comprises inactivated Strep A bacteria in a dried format. The negative control comprises Amies medium. To perform the Liat™ Strep A Assay, an operator first collects a throat swab and places the swab into Amies transport medium. The operator transfers the sample into the Liat™ Strep A Assay tube using a transfer pipette, and scans the tube barcode to identify the test and the sample barcode to code the sample ID with the assay run on the Liat™ Analyzer. The Liat™ Tube is then inserted into the Liat™ Analyzer. The analyzer performs all the test steps and outputs interpreted results (e.g. Strep A Detected, Strep A Not Detected) in ~15 minutes. A report of the interpreted results can be viewed on the Liat™ Analyzer's LCD screen, and printed directly through a USB or network connected printer. No reagent preparation or additional steps are required other than adding the sample to the Liat™ Tube. Because all the reagents are contained within the Liat™ assay tube and no sample or reagent needs to be removed from the tube, crosscontamination between samples is minimized. The results are interpreted by the Liat™ Analyzer software from measured fluorescent signals and real time curve recognition algorithm.

The IQuum Liat™ Influenza A/B Assay performed on the Liat™ Analyzer is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of influenza A virus and influenza B virus RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The test is intended for use as an aid in the differential diagnosis of influenza A and influenza B in humans and is not intended to detect influenza C. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Performance characteristics for influenza A were established when influenza A/H1 and A/H3 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Liat™ Influenza A/B Assay is a rapid, automated in vitro diagnostic test for the detection and differentiation of Influenza type A and type B viral RNA in nasopharyngeal swab (NPS) specimens in universal transport media (UTM) from patients signs and symptoms of respiratory infection. The assay targets a well-conserved region of the matrix gene of Influenza A viral RNA (Inf A target) and non-structural protein (NS) gene of Influenza B (Inf B target). An Internal Process Control (IPC) is also included. The IPC is present to control for adequate processing of the target viruses and to monitor the presence of inhibitors in the RT-PCR reactions. The Liat Influenza A/B Assay is performed on the lab-in-a-tube technology platform. The system consists of a disposable Liat Influenza A/B Assay Tube and the Liat™ Analyzer. The Liat™ Tube uses a flexible tube as a sample vessel. It contains all required unit dose reagents prepacked in tube segments, separated by peelable seals, in the order of reagent use. Manipulating a Liat Tube, the Liat Analyzer performs all assay steps from raw sample and report assay result automatically, During the testing process, multiple sample processing actuators of the analyzer compress the Liat Tube to selectively release reagents from tube segments, move the sample from one segment to another, and control reaction volume, temperature and time to conduct sample preparation, nucleic acid extraction, target enrichment, inhibitor removal, nucleic acid elution and real-time RT-PCR. An embedded microprocessor controls and coordinates the actions of these sample processors to perform all required assay processes within the closed Liat Tube. Turnaround time from sample input to result is ~20 minutes.