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Medline Swabs are now M40 Certified

Jeudi, 01 Septembre 2011 07:29

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The study on persistence of Pseudomonas aeruginosa ATCC BAA‐ 427 (representative of aerobic and facultative anaerobic bacteria),
Bacteroides fragilis ATCC DSM 15130 (representative of fastidious bacteria) by using Deltalab swabs (Stuart transport medium swab, Amies transport medium swab, Amies transport medium with charcoal swab), complies with the American NCCLS M40‐A Vol. 23 No. 34 Quality control of microbiological transport systems; Approved standard, considers that:

a) Deltalab Stuart, Amies and Amies with charcoal swabs are excellent for keeping long term bacterial viability (up to 3 days) at 4‐8⁰C, for aerobic, facultative anaerobic bacteria and anaerobic bacteria.

• Deltalab Amies and Amies with charcoal transport medium swabs are excellent for keeping bacterial viability for up to 3 days at 20‐25⁰c, for aerobic and facultative anaerobic bacteria, and for anaerobic bacteria.
• Deltalab Stuart transport medium swabs are excellent for keeping bacterial viability at 20‐25⁰c; up to 3 days for aerobic and facultative anaerobic bacteria and up to 2 days for anaerobic bacteria.
• Deltalab Stuart, Amies and Amies with charcoal transport medium swabs are excellent for keeping bacterial viability for 24h at 4⁰c for fastidious bacteria.
• Deltalab Amies transport medium with charcoal transport medium swabs are excellent for keeping bacterial viability for 24h at 20‐25⁰c for fastidious bacteria.

b) According to the Roll plate method:

• For viability studies (specimens held at 20‐25⁰c), “there shall be ≥ 5 CFU following the specified holding time from the specific dilution that yield zero‐time plates counts closest to 300 CFU”. Therefore, all 3 kinds of swabs are excellent for keeping bacterial viability up to 48h for anaerobic bacteria.
• For overgrowth studies (specimens held at 4⁰c, “there shall be no more than 1 log increase in CFU between the zerotime count and the counts of the swabs that were held”. Therefore, all 3 kinds of swabs are excellent to avoid bacterial overgrowth up to 48h for aerobic and facultative anaerobic bacteria.
• Swab: As a surgical invasive product of temporary use, is classified as CLASS IIa product in compliance with Guideline 93/42/EEC (Directive of Sanitary Products) amended by Directive 2007/47/EC.
• Tube with transport media: container facilitator of survival and transport of biological samples prior to analysis. Classified as in vitro diagnostic IVD (according to Directive 98/79/EC).
• Bacterial survival time extended to 48hours minimum.
• Paper less plastic Peel Pack is an extraordinary safe system to maintain pack integrity and sterility.
• Superior non‐toxic soft swab tips.
• In vitro use only.
• Lot number/expiry date and tamper evident tube ensure complete traceability and sterility.

The following swabs are just some of those included within the new directives: 300287.2, 30285.2, 300261.2, 300250.2, 300295 and 300297