A dried sample on the Q-Strip works with many analytical technologies, from PCR and immunoassays to clinical chemistry and sequencing. Samples are analyzed in Qvin Labs in Menlo Park, California, or in a laboratory in our network.
Illustrative resultsResults from the analyzer come back to the sample in Samples. The clinical laboratory scientist reviews each result, selects or rejects it with a reason, and releases the panel. Nothing reaches a patient or a study before it is released.
Animation of the Results page in the Samples App: the laboratory scientist selects the HbA1c result for aliquot A1 and releases the panel.
The Q-Pad A1c Test System measures HbA1c, a marker of long-term blood sugar, from a Q-Pad collected at home. It was cleared by the FDA in December 2023 under 510(k) K231465, and its performance shows what a dried menstrual sample can do.
510(k) K231465 Passing-Bablok y = 1.003x − 0.0461, R² = 0.99
y = 0.987x − 0.0365, R² = 0.997
Coefficient of variation (CV). Lower is more precise.
Sixteen medicines and body substances, urine, semen, sweat, vaginal fluid and twenty intimate-care products, tested at four HbA1c levels.
HbC, HbD, HbE and HbS showed no significant interference. High levels of fetal hemoglobin (HbF) do, and the labeling says so.
Samples tested after simulated shipping in extreme cold, heat and humidity, and kits tested across their shelf life.
Indication: monitoring long-term blood sugar control in women with diabetes, aged 18 and older. Not for diagnosing or screening for diabetes. Source: FDA decision summary and study data for 510(k) K231465.
Here are some of the methods that work on the Q-Strip, with example tests and the areas they can serve. They are examples, not the full list: there are many more, and every test is validated on its own.
Detects the DNA of viruses, bacteria and other pathogens.
Example tests
Example areasCervical cancer screening, sexual and vaginal health
Measures hormones and proteins with antibodies.
Example tests
Example areasFertility, menopause, thyroid health, inflammation
Routine analytes on laboratory chemistry analyzers.
Example tests
Example areasDiabetes monitoring, heart and kidney health
Reads epigenetic marks across the genome.
Example tests
Example areasBiological aging and research
Measures gene expression and RNA targets.
Example tests
Example areasResearch and biomarker discovery
Quantifies many proteins and small molecules at once.
Example tests
Example areasWomen’s health research and biomarker discovery
Validate it on the Q-Pad with us, building on the study design the FDA has already reviewed.
