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Revista Cubana de Investigaciones Biomédicas

On-line version ISSN 1561-3011

Abstract

ALFONSO VALDES, Ivonne; ZHURBENKO, Raisa; LOBAINA RODRIGUEZ, Tamara  and  RODRIGUEZ MARTINEZ, Claudio. Quality control and performance testing of CromoCen® SALM according to ISO 11133: 2014 / Amd.1: 2018. Rev Cubana Invest Bioméd [online]. 2023, vol.42  Epub June 29, 2023. ISSN 1561-3011.

Introduction:

In Cuba, a new chromogenic and fluorogenic culture medium was developed for the detection, isolation and differentiation of Salmonella from other Gram negative bacteria. The method and medium were validated and their use was adopted as a Cuban standard. Quality assurance and control of media is essential and mandatory to ensure the reliability of the results of the analysis in which they are used. ISO 11133 establishes minimum criteria and methods to evaluate them.

Objective:

To evaluate the quality and performance criteria of CromoCen® SALM, as recommended in ISO 11133:2014/Amd.1:2018 to demonstrate its reliability for the microbiological analysis of food for human consumption.

Methods:

The physical-chemical quality indicators of three batches were evaluated and a group of them was defined to characterize its quality before and after finishing, as well to evaluate the consistency between batches. For the performance test, 12 strains of different genera were selected. The productivity ratio, the selectivity factor and the electivity of CromoCen® SALM were determined.

Results:

The physico-chemical evaluation showed a consistency between batches in color, homogeneity, appearance of the powder and of the prepared medium. The moisture content and pH values ranged within the established values for this product. The productivity ratio of CromoCen® SALM with respect to tryptone soy agar was greater than 50%, while the selectivity factor was 4. It was shown that in the culture medium a representative group of Salmonella microbial genera can be differentiated.

Conclusions:

CromoCen® SALM meets the quality requirements established for this type of products, according to the current ISO 11133 standard. The correct formulation of the batches, as well as the fulfillment of the quality requirements ensure the proper functionality and match the design purpose.

Keywords : quality control; Salmonella; culture media; ISO 11133.

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