Immundiagnostik AG Presents New PCR Test MutaPLEX RespiraScreen4_Diff_seqc at MEDICA 2022

Immundiagnostik AG (Bensheim, Germany) is presenting its new PCR test MutaPLEX RespiraScreen4_Diff_seqc for the first time at this year's MEDICA, the world's largest annual medical technology trade fair, which is taking place from 14-17 November in Düsseldorf, Germany. The test kit developed by Immundiagnostik is a further development of the existing products MutaPLEX RespiraScreen1 and MutaPLEX Coronavirus and represents a comprehensive real-time PCR diagnostic tool that efficiently, conveniently and reliably masters the expected respiratory diagnostic challenge in every new winter season.

The MutaPLEX RespiraScreen4_Diff_seqc real-time PCR test can be used to detect three different respiratory pathogens highly efficiently in just one approach: Coronavirus, Influenza Virus and RSV=Respiratory Syntial Virus. The innovative combination of two basic PCR techniques, namely qualitative amplification followed by melting curve analysis, allows the respective pathogens to be detected and differentiated in the same experiment. This means that in case of positivity (i.e. in the first step "amplification") in the case of coronavirus two different CoV-2 genes (S=Spike & E=Envelope) are specifically detected and in the case of influenza and RSV respectively the subtypes A and subtypes B are specifically detected. In all three cases, the distinction is made in the second step of the "melting curve analysis".

In addition, the entire diagnostic process is rounded off by the verification of the original sample collection by means of the detection of a human housekeeping gene. In times of pandemic coronalage, which has been ongoing for more than two years now, this is still essential, as the collection of respiratory pathogens from the nasal or oral/pharyngeal region may be suboptimal, resulting in inefficient sample collection. In these rare but not excludable cases, false-negative results in subsequent PCR diagnostics in the laboratory/testing center are inevitably the consequence.

Amplification of the human housekeeping gene on a separate detection channel of the real-time PCR instrument used provides an excellent means of controlling this situation. Detection of the human housekeeping gene provides assurance not only to the processing laboratory, but also to the specimen-submitting physician (and, not least, to the specimen-taking staff of the testing center) that the clinical source material collected and transferred to the laboratory met the requirements of correct specimen collection via swab smear. If the household gene amplification is strongly reduced or missing, the PCR result is not valid and a diagnosis of the patient sample is not possible. As a consequence, a new sample must be requested.

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