This question was closed without grading. Reason: Other
Sep 9, 2011 17:32
12 yrs ago
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English term
Sweden
high negative influenza virus
English
Medical
Medical: Instruments
biomolecular assay
From an IFU for an influenza RT-PRC assay:
The intra-laboratory reproducibility of the XX Influenza A and B assay was evaluated at 3
laboratory sites. Reproducibility was assessed using a panel of 6 simulated samples that include medium
(10x LoD), ***high negative (C20-60 concentration) influenza A virus***, influenza B virus, positive and negative
control samples. Panels and controls were tested at each site by 2 operators for 5 days (8 samples and 3
controls × 2 operators × 5 days × 3 sites = 330).
The intra-laboratory reproducibility of the XX Influenza A and B assay was evaluated at 3
laboratory sites. Reproducibility was assessed using a panel of 6 simulated samples that include medium
(10x LoD), ***high negative (C20-60 concentration) influenza A virus***, influenza B virus, positive and negative
control samples. Panels and controls were tested at each site by 2 operators for 5 days (8 samples and 3
controls × 2 operators × 5 days × 3 sites = 330).
Reference comments
51 mins
Reference:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
A “high negative” sample aiming to represent the analyte concentration below the clinically established cut-off such that results of repeated tests of this sample are negative approximately 95% of the time and results are positive approximately 5% of the time, C5 concentration (e.g., for real–time PCR assays, a sample with an analyte concentration not more than 10 fold below the clinical cutoff of the assay).
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Note added at 53 mins (2011-09-09 18:25:44 GMT)
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
A “high negative” sample (C 5 concentration) : a sample with an analyte concentration below the clinical cut-off such that results of repeated tests of this sample are negative approximately 95% of the time (and results are positive approximately 5% of the time).
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Note added at 1 hr (2011-09-09 18:34:30 GMT)
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http://docs.google.com/viewer?a=v&q=cache:C_AlwvZEPzAJ:www.a...
A “high negative” sample aiming to represent the analyte concentration below the clinically established cut-off such that results of repeated tests of this sample are negative approximately 95% of the time and results are positive approximately 5% of the time, C5 concentration (e.g., for real–time PCR assays, a sample with an analyte concentration not more than 10 fold below the clinical cutoff of the assay).
--------------------------------------------------
Note added at 53 mins (2011-09-09 18:25:44 GMT)
--------------------------------------------------
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
A “high negative” sample (C 5 concentration) : a sample with an analyte concentration below the clinical cut-off such that results of repeated tests of this sample are negative approximately 95% of the time (and results are positive approximately 5% of the time).
--------------------------------------------------
Note added at 1 hr (2011-09-09 18:34:30 GMT)
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http://docs.google.com/viewer?a=v&q=cache:C_AlwvZEPzAJ:www.a...
Note from asker:
| Thank you, Liz. Your information is very explicative. Kind regards, Åsa |
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