| For Use With |
For Method Validation with Quidel Triage TOX Drug Screen, 94600 and Quidel Triage Rapid Visual Read Tests | For use with BioFire RP2.1 or BioFire RP2.1plus on the BioFire FilmArray 2.0 / Torch | For Piccolo Classic and Piccolo Xpress Analyzers | For Piccolo Classic and Piccolo Xpress Analyzers | For use as an External Positive and Negative Quality Control to Monitor the Performance of in vitro Laboratory Nucleic Acid Testing Procedures for the Detection of Influenza A, Influenza B, Respiratory Syncytial Virus and SARS-CoV-2 Virus |
| Features and Benefits |
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- Manufacturer: Maine Molecular Quality Controls Inc M441
- BioFire RP2.1/RP2.1plus Control Panel M441 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the BioFire® Respiratory Panel 2.1 (RP2.1) and BioFire® Respiratory Panel 2.1plus (RP2.1plus) assay performed on the BioFire FilmArray® 2.0/Torch
- BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire RP2.1 assay and BioFire RP2.1plus assay
- This product is not intended to replace manufacturer controls provided with the device
- 6 Positive controls and 6 Negative controls
- Quality control materials should be used in accordance with local, state, federal regulations and accreditation requirements
- The BioFire RP2.1/RP2.1plus Control Panel M441 is intended for in vitro use as reference material to monitor the detection and identification of respiratory viral and bacterial targets in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections
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- BRT Verification Samples are human liquid assayed serum samples used to validate analyzer performance according to CLIA guidelines
- Verification Samples must be run at least every six months in Labs using non-waived Reagent discs 400-0026 (07P02-06) Hepatic Panel; 400-0031 (07P02-13) Basic Metabolic Panel Plus; and 400-0034 (07P02-14) MetLyte Plus CRP
- This product is prepared from purified human serum to which biochemical material (human and animal tissue extracts), chemicals, stabilizers and preservatives have been added
- The verification samples are in a prepackaged liquid form to avoid potential error or contaminate being introduced during reconstitution
- To achieve maximum shelf life for the Verification Kit store unopened at ? -20ºC
- Store vials away from the light
- The Verification Samples can be used for up to 14 days when stored unopened 2-8°C
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- BRT Verification Samples are human liquid assayed serum samples used to validate analyzer performance according to CLIA guidelines
- Verification Samples must be run at least every six months in Labs using non-waived Reagent discs 400-0026 (07P02-06) Hepatic Panel; 400-0031 (07P02-13) Basic Metabolic Panel Plus; and 400-0034 (07P02-14) MetLyte Plus CRP
- This product is prepared from purified human serum to which biochemical material (human and animal tissue extracts), chemicals, stabilizers and preservatives have been added
- The verification samples are in a prepackaged liquid form to avoid potential error or contaminate being introduced during reconstitution
- To achieve maximum shelf life for the Verification Kit store unopened at ? -20ºC
- Store vials away from the light
- The Verification Samples can be used for up to 14 days when stored unopened 2-8°C
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- The Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab) can be used to monitor the extraction, amplification and detection of Influenza A, Influenza B, Respiratory Syncytial Virus, and SARS-CoV-2 molecular testing assays
- The Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab) consists of 6 individually packaged positive control swabs and 6 individually packaged negative control swabs
- This control material is nonautomated and not intended to be used for screening, monitoring, or diagnosis
- Positive Control (six swabs): Influenza A (H3N2) Virus, Influenza A (H1N1) Virus, Influenza B Virus, Respiratory Syncytial Virus, SARS-CoV-2 Virus, Human lung epithelial cells
- Negative Control (six swabs): Coxsackievirus B1, Human lung epithelial cells
- The viral particles have been inactivated using irradiation and chemical treatments, and the human cells have been inactivated using thermal treatment
- Routine use of external quality controls monitor day to day performance of molecular testing procedures
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