Legal Notices and Disclaimer:

Methodology: Total nucleic acid (DNA and RNA) was extracted from patient samples. The DNA Healthcare Solutions Infectious Disease Test utilizes quantitative PCR technology (TaqMan qPCR) to simultaneously detect a wide array of bacteria, viruses and parasites that serve as diagnostic indicators for potential bacterial infection, fungal infection, and antibiotic resistance. Detected pathogens are reported as the number of organisms per milliliter (copies per mL).

This test was developed, and its performance characteristics determined by DNA Healthcare Solutions. It has not been cleared or approved by the US Food and Drug Administration. FDA does not require this test to go through premarket FDA review. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing.

 

Limitation:

A positive detection indicates the presence of the target microorganism(s). A negative detection does not imply the absence of microorganisms other than those listed or does not exclude the possibility that the target sequence is present below the limit of detection. The presence of mutations within the primer regions may lower the test sensitivity. It is recommended that the test results be interpreted in conjunction with all other medical information relevant to the patient’s clinical condition in accordance with appropriate patient management procedures.