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Aflatoxin M1 in milk and dairy products screening tools

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Aflatoxin M1 is the product of aflatoxin B1 transformation in the digestive apparatus of dairy animals. Once these animals are fed with B1 contaminated feed, liver enzymes transform it into aflatoxin M1. This toxin is found then in milk and dairy products and, even if less toxic than its precursor, is still mutagenic and carcinogenic. Due to aflatoxin M1 toxicity and the likelihood of its presence in milk and dairy products, the level of this toxin is strictly regulated from European and International laws.

In the EU, the maximum tolerated level of aflatoxin M1 is 0.05 parts per billion (ppb), and a lower limit of 0.025 ppb is envisaged for so called baby-foods. In the US, the Food and Drug Administration (FDA) established a maximum level for aflatoxin M1 of 0.5 ppb; China –with GB 2761-2011- and the International CODEX ALIMENTARIUS adopted the same limit as well.

Tecna presents here its portfolio of products dedicated to aflatoxin M1 screening in milk and dairy products. In order to fulfill international regulations new kits for extra EU markets have been recently introduced.

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Aflatoxin M1 in milk and dairy products screening tools

  1. 1. Tecna aflatoxin M1 screening tests Complete port-folio of screening kits for determination of Aflatoxin M1 in milk and dairy products
  2. 2. Tecna aflatoxin M1 screening tests Aflatoxin M1 • Aflatoxin M1 is a mycotoxin that naturally occurs in milk and dairy products; it is the product of aflatoxin B1 after it is metabolized by dairy animals. • Aflatoxin M1 is less carcinogenic than its parental toxin, aflatoxin B1, however it is still highly toxic for liver and kidneys in particular. • 1-3% of the aflatoxin that is consumed within feed is excreted in milk within 24 hours from intake. Clearance time ranges between 1 and 4 days.
  3. 3. Tecna aflatoxin M1 screening tests Different options for different regulations Different requirements can’t be adequately fulfilled by a single product. For this reason Tecna implemented a complete port-folio of screening tests to cover all the requirements. The EU limit for aflatoxin M1 in milk is 50 ppt. • I’screen Afla M1 MILK • I’screen Afla M1 The Codex Alimentarius and the FDA fixed the limit for aflatoxin M1 in milk at 500 ppt • Celer® Afla M1 500 • B ZERO AFLA M1 500
  4. 4. Tecna aflatoxin M1 screening tests Product overview • Assay principle: competitive enzyme immunoassay • Applications: raw milk, milk powder • Assay time: 75 minutes • Calibration curve: 5 – 250 ppt • Limit Of Detection – Raw milk: 0.005 ppb = 5 ppt – Milk powder: 0.05 ppb = 50 ppt The leading solution in Italy and Europe for the screening of aflatoxin M1 in milk. I’screen AFLA M1 milk is accreditable in compliance with ISO IEC 14675:2003 No sample manipulation required!
  5. 5. Tecna aflatoxin M1 screening tests • Assay principle: competitive enzyme immunoassay • Applications: raw milk, milk powder, cheese, yogurt • Assay time: 75 minutes • Calibration curve: 5 – 250 ppt • Limit Of Detection – Raw milk: 0.005 ppb = 5 ppt – Milk powder: 0.05 ppb = 50 ppt – Cheese: 0.037 ppb = 37 ppt – yogurt: 0.025 ppb = 25 ppt The leading solution in Italy and Europe for the screening of aflatoxin M1 in milk. I’screen AFLA M1 is accreditable in compliance with ISO IEC 14675:2003 Product overview
  6. 6. Tecna aflatoxin M1 screening tests Milk validation • Each prototype developed by Tecna R&D department is subject to internal validation before industrialization and production. • Of 20 samples with < 5 ppt of aflatoxin M1 (HPLC), Tecna kits revealed no positives: 100% specificity • Of 20 samples spiked at 5 ppt of aflatoxin M1, no determination with Tecna kits resulted < 5 ppt: 100% sensitivity • Kit precision was set onto two Reference milk materials: • 21.50 ppt: Intra-assay CV 3.7% - Inter-assay CV 8.0% • 55.19 ppt: Intra-assay CV 2.8% - Inter-assay CV was 8.5%
  7. 7. Tecna aflatoxin M1 screening tests I’screen AFLA M1 performances 10 blank low-fat and 10 blank whole yogurt samples were run with theoretical cut off < 25 ppt. Tecna kit revealed no positives: 100% specificity The same 20 samples were spiked at 40 ppt of aflatoxin M1, no determination with Tecna kit resulted in a false negative: 100% sensibility To test the kit accuracy a low fat and a whole yogurt samples samples were randomly selected and spiked at 50, 100 and 250 ppt of aflatoxin M1. The resulting mean recovery was 81+11% Yogurt 50 different incurred cheese samples were analysed by HPLC and by I’Screen AFLA M1 ELISA kit. The mean recovery value was: 108+15% A specific sample procedure was implemented for firm cheese; the mean recovery obtained by analysing incurred samples was 116+15% Z-scores obtained in two different Proficiency tests for cheese were - 0.21 and 0.17. Cheese
  8. 8. Tecna aflatoxin M1 screening tests It is important to monitor the kit performances. As a producer, Tecna performs a strict quality control before releasing each batch of I’screen AFLA M1 milk, by analysing at least three reference milk materials in three sessions, three replicates each. Quality control Acceptance criteria 68.3% results must not exceed 1 standard deviation of the reference sample specs Intra-assay CV < 15% Inter-assay CV < 20%
  9. 9. Tecna aflatoxin M1 screening tests In order to constantly monitor immunoassays performances, Tecna participates every year to various proficiency tests from different suppliers. Participation to proficiency tests Since 2005, the average z-scores Tecna obtained with its aflatoxin M1 kits is 0.66 (n=35)
  10. 10. Tecna aflatoxin M1 screening tests Product overview • Assay principle: competitive enzyme immunoassay • Applications: raw milk, milk powder • Assay time: 20 minutes • Calibration curve: 25 – 500 ppt (up to 100 – 2000 ppt) • Limit Of Detection – Raw milk: 0.025 ppb = 25 ppt – Milk powder: 0.25 ppb = 250 ppt A new FAST screening device for the quantitative detectin of aflatoxin M1 in milk No sample manipulation required!
  11. 11. Tecna aflatoxin M1 screening tests Product overview • Assay principle: competitive enzyme immunoassay • Applications: raw milk, milk powder • Assay time: 20 minutes • Calibration curve: 25 – 500 ppt (up to 50 – 1000 ppt) • Limit Of Detection – Raw milk: 0.025 ppb = 25 ppt – Milk powder: 0.25 ppb = 250 ppt A new FAST screening device for the quantitative detectin of aflatoxin M1 in milk. B ZERO AFLA M1 500 is the master curve version of Celer® AFLA M1 500 No sample manipulation required! Only one standard for the calibration curve: more analysis with the same kit!
  12. 12. Tecna aflatoxin M1 screening tests • Assay principle: competitive enzyme immunoassay • Applications: raw milk, milk powder • Assay time: 30 minutes • Calibration curve: 10 – 200 ppt • Limit Of Detection – Raw milk: 0.01 ppb = 10 ppt The first master curve ELISA kit for the detection of aflatoxin M1 in milk within EU MRL. No sample manipulation required! Only one standard for the calibration curve: more analysis with the same kit! Product overview
  13. 13. Tecna aflatoxin M1 screening tests Focus on B ZERO AFLA M1 • The B ZERO line of Tecna kits is dedicated to who implements few analysis. • The B ZERO AFLA M1 ELISA kit leads to quantitative results by means of a VIRTUAL MASTER CURVE – provided within each batch – in 20 minutes only! • At each analytical session, the analyst can save the wells dedicated for each calibrator; it is sufficient to run just the ZERO STANDARD and the SAMPLES! To analyze 3 samples, in a usual immunoassay at least 5 wells have to be used for calibrators. In the B ZERO format, only 1 well has to be used to run the ZERO standard.
  14. 14. Tecna aflatoxin M1 screening tests Why Tecna? • Tecna provides more information to check if the result of each assay is valid or not. • Tecna organizes theoretical and practical trainings to its customers. • Tecna supports customers on the road to Quality Assurance of screening results (ISO17025). Visit us at www.tecnalab.com!

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