MMDL testing services

The Laboratory offers several Plasmodium assays depending on the Context of Use:

Available for use as an Safety/Efficacy Endpoint Assay in malaria clinical trials and for selected clinical use:

• • • Triplex Reverse Transcription PCR for pan-Plasmodium 18S rRNA, P. falciparum 18S rRNA, and host control mRNA

      • Same-day testing support for Seattle-based clinical trial studies

      • Batched testing support for other studies

      • Assay methodology reviewed as part of the laboratory's FDA Biomarker Qualification effort.

      • NOTE REGARDING CLINICAL USE: The above assay is available through UW Laboratory Medicine & Pathology for selected clinical use as a Laboratory-developed Test. Clinical use of this test is not currently intended to replace the use of blood smears/RDTs for emergent malaria diagnosis in symptomatic patients (use MALP test for blood smears/RDT through UW Laboratory Medicine). As of May 6, 2024, the clinical version of this test includes reflexive Sanger sequencing of samples that are Pan-Plasmodium positive but P. falciparum negative.

Available for field study use (Research Use Only):

• • • All assays above, plus modifications to include P. falciparum gametocyte-specific markers or Babesia-specific markers are available.

    • Sanger sequencing-based species identification of non-P. falciparum infections

Other laboratory services:

• • • Validation sample test production and/or testing

    • Quality assurance testing

    • Clinical trial design

    • Laboratory development