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100% Accurate
Clinicians must have accurate measurements of Aa, Pg, Td, Tf, and Fn concentrations, the primary drivers of periodontal disease, to combine with other patient-specific factors as they develop patient
treatment plans intended to ensure the best possible outcomes for their patient. HR5's accuracy sets the gold standard for clinical decision-making.
Our Technology
HR5 is the most accurate* and sensitive test on the market.
*Verified by the SalivaDirect Initiative at Yale School of Public Health
"The results of our verification of the HR5 test matched 100% with the claims that Direct Diagnostics makes about its limit of detection. There were zero discrepancies."
–Representative from the SalivaDirect Initiative at the Yale School of Public Health
Why does this matter?
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If the lab or the technology in the lab presents inaccurate data, the patient information is incorrect: thus, treatment decisions become incorrect as well.
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Some systems are designed more for research than clinical accuracy, while our systems are designed for more accuracy in clinical decision making.
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Quantitative DNA-PCR (qPCR) systems are the gold standard for accuracy in modern technology.
The HR5 Test Includes:
Level of Detection:
10 genome copies for Aa, Pg
100 genome copies for Td, Tf, Fn
Strains & sub-species:
HR5 test quantifies all known strains and subspecies of Aa, Pg, Td, Tf, & Fn
Exact Quantities:
Results are presented in Scientific Notation using coefficients and exponents. x.y x 10z
What is qPCR, and why should I care about the testing technology?
With HR5, you can have confidence in your test results, knowing that accuracy is the foundation upon which we've built our HR5 test.
FAQ
Is the HR5 test FDA approved?
HR5 test is a Laboratory Developed Test (LDT) refers to a diagnostic test created, validated, and performed within Direct Diagnostics. Unlike FDA-approved tests, LDTs do not require regulatory approval before use, allowing for more rapid development and implementation. The governing authority for LDT tests like ours is the Clinical Laboratory Improvement Act of 1988 (CLIA). This governing body is a U.S. group of medical authorities that control the release of lab tests such as HR5. LDTs play a crucial role in providing timely and personalized healthcare solutions to patients.
Benefits of qPCR
Simple workflow with no need for complex sample preparation steps
Low instrument cost
Accurate quantification is possible with an existing target
Easy handling
Quantification is feasible without DNA/RNA extraction
Enables absolute quantification
What is qPCR?
Quantitative Polymerase Chain Reaction (qPCR) is a powerful molecular biology technique used to quantify DNA or RNA molecules in a sample. Understanding qPCR is crucial because it enables precise measurements, detection of pathogens, and diagnosis of diseases with high sensitivity and specificity, contributing significantly to research and clinical diagnostics. By leveraging qPCR technology, researchers and clinicians can make informed decisions about treatment strategies, monitor disease progression, and track the effectiveness of interventions, ultimately leading to improved patient outcomes.