University of the Witwatersrand, Johannesburg

Edith Erika Machowski

Bavesh Davandara Kana

Provided herein is a nucleotide cassette comprising an inducible promoter, a nucleotide sequence that corresponds to at least one single stranded RNA diagnostic target, a nucleotide sequence that encodes artemin, a molecular switch and a nucleotide sequence that encodes a DNAse enzyme and is under control of the molecular switch, wherein the single stranded RNA diagnostic target is a sequence detected by a molecular diagnostic assay. In some embodiments the nucleotide cassette can be used to obtain an RNA expression product. Also provided are vectors and cells comprising the nucleotide cassette or the RNA expression product thereof. The nucleotide cassette can further be used to obtain a diagnostic control composition comprising a non-pathogenic recombinant bacterium having a modified genetic content comprising the nucleotide cassette and to methods of producing such recombinant bacteria.

Diagnostic control compositions

The present invention relates to a recombinant bacterium based on a non-pathogenic bacterium that has a modified genome containing a nucleic acid of interest from a pathogen that is detected by a molecular diagnostic assay and that mimics the diagnostic profile of the pathogen. The invention further relates to a diagnostic control composition comprising the recombinant bacterium and to methods for producing the recombinant bacterium. The recombinant bacterium is a safe, reliable quality control for the detection of pathogens such asand. The invention also relates to a kit comprising either the recombinant bacterium, compositions containing the recombinant bacterium or bacteria produced according to the method of the invention.

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Johannesburg, South Africa

Edith Erika Machowski