Laboratory Customer Survey

“Excellent service – keep up the good work, FACTS Laboratory!” | “The service is excellent.” | “Keep up the good work and service!”

We want to take this opportunity to thank all of you who participated in the FACTS laboratory customer survey. Thank you for all the wonderful positive feedback and suggestions for possible improvements. We welcome all feedback and embrace opportunities for improvement.

We will make it our mission to ensure we continually supply the high-quality results and services to which our clients have grown accustomed.

This is a wonderful opportunity for us to give feedback on some queries from the survey.

Q. Why are FACTS test reports not signed?

A. Test reports are electronically generated by our Laboratory Information Management System (LIMS). Reports generated for accredited methods, for example, are approved by a technical signatory (whose name is displayed on the test report). It is an ISO 17025 requirement for reports to be approved by an appropriately qualified person in the case of accredited methods, a SANAS-approved technical signatory. Currently it is not required by the standard for the reports to be signed.

However, we were recently informed by SANAS that going forward, it will be a SANAS requirement for reports to be signed. Because our reports are generated automatically, we will need to use authenticated and registered electronic signatures. We are in the process of implementing an electronic signature system, in accordance with applicable regulations.

Q. Why does FACTS not indicate in reports whether results are acceptable or not?

A. The FACTS laboratory is accredited by SANAS for a number of ELISA and PCR methods. However, the scope of accreditation does not include results interpretation; thus, although we are able to interpret results, we are not allowed to add interpretation comments to test reports. Please feel free to contact us if you are ever unsure of what a result means, you want to understand the risk to the consumer, or you would like to better understand what a result means in terms of your allergen controls.

Q. Does the FACTS lab offer discounts?

A. Yes, of course we do. We have two discount tiers; 10% if 6 to 10 samples are received for the same test on the same date; and 15% if 11 or more samples are received for the same test on the same date.

Q. What does the information in the Test Results section of a FACTS ELISA report mean?

1. Which method was used for the analysis? FACTS uses either ELISA- or PCR-based analysis for allergen testing. The selection of the method depends on a number of factors; FACTS will select the method best suited to your analysis requirements. It is important to communicate the reason for analysing your sample on the FACTS acceptance note.
2. The method ID is a FACTS internal laboratory method reference number, referenced on the SANAS schedule of accreditation.
3. The method range of quantification is the ELISA’s range of detection – this varies between different ELISAs.
4. All analysis has a measure of uncertainty (MoU); this is a value allocated as an allowance for differences in results. Using the result 6.14 ppm as an example: the MoU ±1.28 means that the result could be in the range 4.86 ppm to 7.42 ppm.
5. The explanation of the results will always present one of three possible outcomes. These are:
<LLOQ = Below lower level of quantification of the method; WROQ = Witan range of reliable quantification of the method; >ULOQ = Above the upper limit of quantification of the method.
The comments are a written explanation of the results.
 Please note that the comments are not an interpretation of the safety of the product for food-allergic consumers.
6. The regulatory limits show the allowable levels for allergens in the South African regulations.Please note that SA regulations only comment on the allowable limits for gluten; this is also the case internationally.
7. With the exception of gluten results, ELISA results are expressed as ppm allergen, e.g. ppm peanut. When completing a VITAL^® tool risk assessment, results must be converted to ppm protein from the allergen source. In this section FACTS supplies a conversion factor to calculate the corresponding protein values.
8. Each report will advise the VITAL^® tool reference dose for the specific allergen. The VITAL^® tool reference doses were developed by the VITAL^® tool Scientific Expert Panel, and are defined as: “the protein level (total protein in milligrams from an allergenic food) below which only the most sensitive individuals (between 1% and 5%, depending on the quality of the data set available) in the allergic population are likely to experience an adverse reaction.” For more information, visit the Allergen Bureau website.