Examples of using Lot testing in English and their translations into Russian
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Official
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Colloquial
The testing reports will remain the propertyof the NRA(and WHO) which has the mandate to order lot testing.
The sampling frequency for further lot testing may be increased.
All data collection sheets and lot testing reports should be kept for a period of 5 years following the conclusion of the testing. .
These data were then transcribed into this lot testing report.
Attachments[insert lot testing reports, FSCA reports, etc.]: q Yes q No 5.
This will be a requirement when the lot fails to meet the lot testing acceptance criteria.
The test results should be entered into the lot testing report by the technical supervisor and double-checked against the data collection sheets, see Annex 2.
After a period of consistently acceptable results, the sampling frequency for further lot testing may be reduced.
Lot testing ensures that only lots with acceptable test results are distributed to laboratories and testing sites all over the country.
WHO and the NRA should monitor the results of lot testing for any trends or shifts.
The staff performing the lot testing should be qualified and competent to undertake the task and to demonstrate that they can perform the test procedure correctly.
The Rapid Diagnostic Test Evaluation Programme provides the service of lot testing of rapid diagnostic tests at several regional centres.
The version number of the instructions for use should be recorded, andthe instructions for use reviewed for any changes since the last lot testing event took place.
Transcribe or verify that correct transcription of final results of lot testing into the lot testing report to be provided to the NRA and WHO.
Secondly, lot testing can assess variation between lots and captures deviation in performance in comparison with the preceding lots. .
The reference laboratory should present testing results in the form of a lot testing report as defined in Annex 2 which would be sent to the relevant NRA and to WHO.
The contract and the scope of work should describe the test procedures from contractor testing, first article and pilot lot testing, on to production lot testing. .
We have already produced a pilot lot; testing is to start in the nearest future," says Vice-Rector for Research, Doctor of Engineering Sciences, Professor Aleksandr Dyakonov.
The testing should be carried out using the same standardized lot verification panel as the pre-distribution lot testing, andtesting results presented in the form of a lot testing report as defined in Annex 2.
Post-distribution lot testing carries a different risk as the product has already been in use, and depending on the through-put of the testing site, it may or may not be close to its expiry date.
Such information may arise from any aspect of post-market surveillance:pre-distribution or post-distribution lot testing, report from the field, review of IVD design, changes in production or component specifications, etc.
For instance, stakeholders may choose to begin with pre-distribution lot testing andlater add post-distribution lot testing, or to start with complaint reporting and later add lot verification testing. .
Since the performance of various production lots of individual productsoften varies over time, it is recommended that all lots of procured products be checked for quality through lot testing prior to large-scale deployment in the field and that a process for the monitoring of rapid diagnostic test performance in the field be put in place.
Each assay should be performed under identical conditions to minimize the chance that differences in lot testing results were not caused by differences in the environmental and/or testing conditions(including equipment such as instruments, pipettes, etc.);
The production process should incorporate in-processinspections by the producer for components, sub-assembly lot acceptance testing and 100 percent acceptance testing for each end lot.
Table 3- Rationale and processes for lot verification testing.
Lot verification testing verifies whether or not the IVD correctly classifies a set of clinically-derived reference specimens in a panel.
Designing a collection form to suit varying levels of technological sophistication among respondents is difficult and requires a lot of testing.
Detail on preparation of specimen panels and lot verification testing by the reference laboratory is given in Part IV of this document.