SUGGESTED PROCEDURES FOR
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1 DRAFT The NELAC Institute Presents: SUGGESTED PROCEDURES FOR LOQ
2 TNI plays well with Others These suggested procedures are compliant with NELAC and TNI standards, and can provide a dataset suitable for other Quantitation Limit protocols, including: Detection/Quantitation Federal Advisory Committee procedure Office of Water MRL Texas PQL DoD QSM v4.1
3 TNI DEFINITION - LOQ Limit of Quantitation The minimum levels, concentrations, or quantities of a target analyte that can be reported with a specified degree of confidence.
4 What is a TNI LOQ? I see some yellow pollen on the stamens below. This magnification is at my Limit of Detection (LOD). If it were any smaller I wouldn t see the pollen. Magnif Magnification 2x How many pollen particles do I see? (quantitate?) I think maybe 3
5 TNI DEFINITION - LOQ I wasn t really sure at 2x how many pollen particles there were. But at 5x I am sure I am reliably quantitating Magnification 5x LOD is 2x (I can see it) LOQ is 5x (I can reliably quantitate)
6 Exceptions for LOQ An annual LOQ verification is not required if the LOD was already determined or verified annually on that instrument.
7 Requirements: All sample processing steps must be included in the determination of the LOQ
8 Requirements: An LOQ verification study is not required for any component or property for which spiking solutions or quality control samples are not available or otherwise inappropriate. Such as ph or temperature.
9 Requirements: The LOQ verification sample: a. Must be spiked at 1-2 times the claimed LOQ, b. And recovery must be within established control limits. Limits % Result 94% VERIFIED percent LOQ Verification Spike LOD LOQ 2xLOQ concentration
10 Requirements: The LOQ verification sample: a. Must be spiked at 1-2 times the claimed LOQ, b. And recovery must be within established control limits. Limits / % 150% SD % Result 94% Whatever is reasonable! percent LOD LOQ 2xLOQ concentration
11 Requirements: When an LOD is determined or verified by the laboratory, the LOQ shall be above the LOD. Translation: They can not be the same number zero LOD LOQ
12 If you don t require an LOD, then you don t have to check that your LOQ is greater than your LOD!
13 Requirements: What? Verify LOQ annually In each quality system matrix AND for each technology ON EACH INSTRUMENT??
14 Requirements: Document your procedures for LOQ determination and verification for each quality system matrix type. My Quality Manual or SOP How my LOQ is determined in: a. Water b. Sediment c. Tissue Please be sure to check the appropriate TNI module for analysisspecific LOD or LOQ requirements
15 Recommendation: Because your lowest calibration standard will be your LOQ concentration or lower, pick an LOQ that will pass calibration criteria. LOQ
16 Recommendation: If you have an LOD that is about as low as you can go, then pick an LOQ that is at least 2 x your LOD LOD LOQ
17 Q: Can your LOQ be anything you want? A: As long as it is greater than your LOD. And it meets all client or program requirements
18 Recommendation: If you want to comply with other programs that require multiple spikes for verification, we recommend you first test with just one spike. If the LOQ was too low, you didn t waste time or money preparing the rest.
19 Recommendation: To be compliant with other programs by analyzing multiple LOQ spikes, we recommend Analyzing at least 2 replicates on each instrument for a total of at least 7 replicates. Replicates should not all be analyzed in a single batch a more representative data set is obtained if the samples are spread over time.
20 Thought: If you make an LOQ spike part of your routine quality assurance, you won t have to bother doing a separate study at the end of the year.
21 REVIEW: Your TNI LOQ wish-list something that Something meets about program twice the and LOD customer would be requirements. nice. ohhhh. And don t forget different matrices or technologies. If this LOQ something won t pass for that them can be (even though verified it s the on same each analyte), I may require a separate maybe something instrument that would LOQ pass for calibration those. criteria and
22 end
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