liat flu test package insert|For In Vitro Diagnostic Use : Big box store The cobas® liat SARS-CoV-2, Influenza A/B & RSV assay for use on the cobas® liat system is a multiplex real-time polymerase chain reaction (PCR) test that detects and differentiates SARS .
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Press the power on/off button to start the Select “Login” on the screen of the cobas® cobas® Liat® Analyzer. Liat® Analyzer. Enter user name when prompted, select “OK”. Enter user . See moreNote: If the repeated run is still invalid, contact your local Roche representative. See moreEnsure that the cobas® Liat® Analyzer is powered on. Select “Login” on the screen of the cobas® Liat® Analyzer. Enter user name when . See moreNote: If the repeated run is still invalid, contact your local Roche representative. See more
Access important product documentation including relevant certificates and other resources. Detect and differentiate SARS-CoV-2, influenza A and influenza B in 20 minutes from a single sample and in just one RT-PCR test for use on the .The cobas® liat SARS-CoV-2, Influenza A/B & RSV assay for use on the cobas® liat system is a multiplex real-time polymerase chain reaction (PCR) test that detects and differentiates SARS . The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is an automated rapid multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) .
Your product is an automated multiplexed nucleic acid test for use on the cobas Liat System intended for the simultaneous rapid in vitro qualitative detection and differentiation .The test is designed to simultaneously detect four types of viruses: two types that cause influenza (type A and Type B), RSV and the virus that causes COVID-19 (SARS-CoV-2) in .Operator should carefully read this entire package insert before using the cobas® Influenza A/B assay. Follow all instructions to ensure correct assay performance. NOTE: For the remainder .
cobas® liat SARS
Read the Package Insert and User Manual for complete test procedure and information before performing this test. Test Components Nasopharyngeal Swab Test Procedure • For use with .The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® liat system is a multiplex real-time polymerase chain reaction (PCR) test that detects and differentiates .Liat ® Influenza A/B Assay: The cobas ® Liat ® ®Influenza A/B nucleic acid test for use on the cobas ® Liat System (cobas ® Liat Influenza A/B) is an automated multiplex real-time RT-PCR .
RNA from SARS-CoV-2, influenza A, and influenza B is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV . Test performance for influenza A/B virus detection as well as overall assay workflow and field usability were established in previous studies (10 – 12) of the cobas influenza A/B and respiratory syncytial virus (RSV) test .
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cobas® SARS-CoV-2 & Influenza A/B 09216235001-01EN Doc Rev. 1.0 4 Intended use The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas®SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS .The cobas ® Influenza A/B and RSV Nucleic acid test for use on the cobas® Liat® System (cobas ® Influenza A/B & RSV) is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus, Influenza B virus and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens from patients with .tube that holds the reagents required to perform a test on the cobas® Liat® Analyzer. For the remainder of this Package Insert, the cobas® Liat® System may be referred to as the System and the cobas® Liat® Analyzer may be referred to as the Analyzer. I. Intended Use The cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas .“Direct Comparison of Alere i and cobas Liat Influenza A and B Tests for Rapid Detection of Influenza Virus Infection.” Journal of Clinical Microbiology 54(11): 2763–2766. 2Roche cobas Liat Strep A Package Insert, 510(k) data. 3Roche cobas Liat Influenza A/B Package Insert, 510(k) data. 4Roche cobas Liat Influenza A/B and RSV Package .
Quick Reference Instructions cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System 08175764001-01EN Page 3 of 5 Note: Start the cobas® Liat® assay run as soon as possible, but no later than 4 hours after adding the sample to the cobas® Liat® tube. 3. Insert cobas® Liat® Tube a. Select Scan and re-scan the cobas® Liat® tube barcode.For performing cobas® liat SARS-CoV-2, Influenza A/B & RSV test 1 cobas® liatSARS-CoV-2, Influenza A/B & RSV assay tube 1 specimen in collection media 1 transfer pipette . have read the Package Insert, i.e. Instructions for Use. Lot validation procedure For each new lot of assay tubes, controls must beThe cobas SARS-CoV-2 Nucleic acid test for use on the cobas® liat System - IFU - EUA-IVD, v3.0, 06-04-2023; cobas SARS-CoV-2 Nucleic acid test for use on the cobas® liat System - CE - IVD - English v2.0, 11-01-2023. Pleasanton, CA; Roche Molecular Systems is an automated real-time RT-PCR assay intended for the rapid in vitro qualitative detection of SARS-CoV-2 in self .
The cobas liat SARS-CoV-2, Influenza A/B & RSV -nucleic acid test authorized for emergency use further expands and complements Roche’s broad portfolio of single and multiplex tests intended to help diagnose and address the needs of patients presenting with symptoms of respiratory illness, including the following assays: cobas® SARS-CoV-2 .
1 cobas® Influenza A/B & RSV assay tube from this lot b. Select Assay Menu on the main menu of an Analyzer. c. Select New Lot at the bottom of the list. d. Select Scan and scan the Package Insert Barcode on the Package Insert Barcode Card from the cobas® Influenza A/B & RSV assay tube Pack. e. Select Scan and scan the Negative Controltube that holds the reagents required to perform a test on the cobas® Liat® Analyzer. For the remainder of this Package Insert, the cobas® Liat® System may be referred to as the System and the cobas® Liat® Analyzer may be referred to as the Analyzer. I. Intended Use The cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas .A/B, Influenza A/B & RSV, or Strep package insert) A: An invalid result means that the presence or absence of Influenza A/B, Influenza A/B & RSV, and Strep A cannot be determined. Repeat the same assay with the sample or, if possible, a new sample. If you switched to molecular testing from a traditional rapid test, you now have the possibilityPackage Insert cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System 08118060190-01EN Page 3 of 34 IV. Reagents and Instruments A. Materials Provided The cobas® Influenza A/B & RSV assay Pack (Cat # 08160104190) contains sufficient reagents to process 20 specimens or quality control samples.
Resources for this step. cobas® liat sw 3.4 User Guide version 11.0 + US supplement (v3.2). cobas® liat sw 3.5 User Guide version 12.0 + US supplement (v3.2). Quick Start Guide. cobas® Influenza A/B & RSV Policies and .The cobas ® SARS-CoV-2 Nucleic acid test for use on the cobas® liat system (cobas ® SARS-CoV-2) is an automated real-time RT-PCR assay intended for the rapid in vitro qualitative detection of nucleic acid from SARS-CoV-2 in self-collected anterior nasal (nasal) swabs (collected in a healthcare setting with instruction by a healthcare provider) and healthcare .
cobas® SARS-CoV-2 & Influenza A/B Store at 2-8°C 20 tests (P/N 09211101190) 2 cobas® transfer pipette packs (12 pipettes/pack - P/N 09329676001) 1 Package Insert Barcode Card Reagents in cobas® SARS-CoV-2 & Influenza A/B assay tube Reagent ingredients Safety symbol and warninga cobas® ®Liat Lysis Buffer Citric acid, sodium phosphate,Package Insert cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System 07806108190-01EN Page 3 of 28 IV. Reagents and Instruments A. Materials Provided The cobas® Influenza A/B Pack (Cat # 07341890190) contains sufficient reagents to process 20 specimens or quality control samples.
1 cobas® Influenza A/B & RSV assay tube from this lot b. Select Assay Menu on the main menu of an Analyzer. c. Select New Lot at the bottom of the list. d. Select Scan and scan the Package Insert Barcode on the Package Insert Barcode Card from the cobas® Influenza A/B & RSV assay tube Pack. e. Select Scan and scan the Negative Control
cobas ® liat SARS-CoV-2, Influenza A/B & RSV 10162490001-01EN Doc Rev. 1.0 4 Intended use The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is an automated rapid multiplex real .
cobas® SARS-CoV-2 & Influenza A/B 09216235001-05EN Doc Rev. 5.0 4 Intended use The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas®SARS-CoV-2 & Influenza A/B) is an automated rapid multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) test(COVID-19), influenza A, influenza B, and/or respiratory syncytial virus (RSV) using the cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. This Fact Sheet contains information to .(COVID-19), influenza A, influenza B, and/or respiratory syncytial virus (RSV) using the cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. This Fact Sheet contains information to .
cobas® SARS
Nucleic Acid Test for use on the cobas Liat System? The test is designed to simultaneously detect three types of viruses: two types that cause influenza (type A and
%PDF-1.6 %âãÏÓ 384 0 obj > endobj 413 0 obj >/Filter/FlateDecode/ID[04A0F1F6A25DDEA1B572A7300B4FA6A3>94EA3FD76D14EE4299EA2F0ABC8B992C>]/Index[384 48]/Info 383 0 R .1 cobas ® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas ® Liat ® System, Package Insert V01, Pleasanton, CA; Roche Molecular Systems, Inc., 2020. *Compared to a composite comparator of three highly sensitive FDA-authorized laboratory-based RT-PCR EUA essays; 510(k)/CLIA-waiver data using NPS specimens **Compared to an FDA-acceptable . Of the 42 samples that were Liat test influenza A positive and RADT influenza A negative, 40 were confirmed positive by RealStar, one was negative by RealStar, and one was excluded from analysis for an invalid RealStar result. . Roche Diagnostics. cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System [package insert .
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liat flu test package insert|For In Vitro Diagnostic Use