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Cost-Effective HIV Viral Load Assay

HIV Assay Cassette Design

Customer Scenario

In the clinic, about 1 mL of blood is drawn and taken to the lab for testing. The healthcare worker opens the cassette, inserts the blood sample with the assay reagents, and seals the device to contain infectious materials. Inside the cassette, the blood sample runs through porous layers where viral material can be exposed and analyzed to assess viral load. Within 30 minutes, the test results are available to the patient.

Workflow

The diagram below demonstrates the workflow that healthcare workers will experience in the clinic when using the HIV viral load assay. Please review our customer scenario video to see how this device will work in the clinic.

Device Requirements

  • Inexpensive
  • Efficient
  • Effective
  • Stable
  • Mass Producible
RequirementsMetrics
Cost (USD)$10 ± $5 per unit
Time before receiving results (min)30 – 90 min
Blood required (μL)750 ± 10 μL
Effective diagnosis (%)90 – 100%
Shelf life (months)6+ months
Temperature (°C)20-50 °C
Humidity (%)50-90%
Number of parts2 ± 1 parts
Here are the top device requirements outlined by our customers with included metrics.

Cassette CAD & 3D Printed Model

As shown in the figures, the cassette features two lids in different sizes with a blood inlet. In clinical settings, medical workers should collect about 1 mL of blood from patients and apply it to the inlet through lid #1. After 30 minutes, an image is taken with a phone through lid #2 for the result.

L-TOE CAD & 3D Printed Model

The figures demonstrate the Light-Tight Optical Enclosure (L-TOE) that will be used to take the image for the result. At the bottom of the device, there is a sunken part in the shape of the cassette with lid #2 open. The cassette can be slide in through the gap on the side of the top half of L-TOE. The phone can be secured in place on top of the device. In the future, the L-TOE will be manufacturing using cardboard.

Life Cycle

The HIV viral load assay goes through many phases in its life cycle from production and transport to use in a clinical setting. The life cycle of the device is divided into two main phases: preclinical care (orange) and clinician care (green). Preclinical care pertains to the life of the product in the manufacturing and shipment stages. Clinician care pertains to the clinical uses of the device. The clinics would also have biohazard waste disposal, further ensuring safety.
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