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Specimen Validity

Rapid and Accurate Specimen Validity Testing When Toxicology Results are Critical

Specimen tampering and laboratory mix-ups can have considerable implications for toxicology labs and their clients. Additionally, positive results are often questioned, leaving labs to justify their results. Current sample validity testing options mostly rely on in-person monitoring and standard assays for temperature, pH, oxidants, creatinine, and specific gravity in urine specimens. However, they fail to detect mixed, swapped, and synthetic urine samples and cannot confirm the identity when results are positive.

Robust, Accurate Results Backed by DNA

The iPLEX® Pro Sample ID Panel leverages the power of genetic testing to deliver rapid sample identification and authentication, ensuring specimen submissions are accurately matched to the provider. The panel uses 44 single nucleotide polymorphisms (SNPs), unique DNA patterns revealed by a PCR reaction, to map a genetic profile for each subject and provide a high degree of certainty in sample matching.

Easily Detect Sample Substitution or Mishandling

With a one-time oral swab, laboratories can create a person’s genetic profile to which all follow-up urine specimen submissions are compared. The iPLEX Pro Sample ID+ reference matching software automatically compares test samples to the original reference profile, thus confirming if it is valid, or, alerting the laboratory that manipulation or a sample mix-up has occurred. This overcomes sample handling errors and specimen manipulation that other standard forms of testing can’t detect, leading to more precise screening results.

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Assays by Agena scientists design and develop custom research use assays. Assays can be developed for targeted germline or somatic genotyping, translocations, copy number variants and methylation profiling.

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