TNI Logo The NELAC Institute

Standard Interpretation



Standard: 2009 TNI
Section: V1M4, Section 1.7.3.2.3 and Note


REQUEST:

The language in the note under Section 1.7.3.2.3 is as follows, "The matrix spike may be used in place of this control as long as the acceptance criteria are as stringent as for the LCS" seems to indirectly indicate that an analyte in the MS which meets the LCS acceptance criteria may be used in place of the same analyte in the LCS that does not pass the LCS criteria.

In short, if an analyte in the LCS fails the LCS acceptance criteria can you use the same analyte from the MS instead if it meets the LCS acceptance criteria.

My interpretation is that this is not the intent of the note in this section of the standard to allow this however I have received questions from several sources regarding the applicability of the above requiring further explanation.

I look forward to your response.

TNI FINAL RESPONSE:

The language "used in place of" is interpreted to mean that the batch does not contain an LCS. The quality of the data is being evaluated with an MS instead of the LCS. However, if an LCS is present in the batch, it must be analyzed and evaluated to assess the quality of the data, independent of the results of a MS. If the method requires an LCS then a MS may not be substituted.

The committee will clarify the wording of this section in next revision of the Standard.