Multiplo Rapid Test for the Detection of Antibodies | MedMira, Inc.

General Description
MedMira’s unique Rapid Vertical Flow (RVF) Technology™ features simple steps and instant results. Its current single disease product portfolio for infectious diseases is comprised of Reveal HIV, Reveal HP, and Reveal TP. Its current offer for multiplex product line (the Multiplo) includes combination of testing solution for HIV1/2, hepatitis B and C and syphilis. These tests can be deployed at all possible settings such as POCT, over the counter (OTC), and laboratories. These types of tests also eliminate the need for cold chain transport. MedMira’s world-class technology offers a number of distinct advantages: speed, multiplex testing, quality and value. MedMira diagnostics are the fastest rapid flow-through diagnostics for multiplex testing of infectious diseases in the world. In less than three minutes, users can perform the test and have an instant result. MedMira’s technology is unique in its ability to detect multiple biomarkers specific to several diseases on a single cartridge using a single specimen.

Technical Description
The technology facilitates the formation of highly specific antigen-antibody reactions allowing disease-specific biomarkers in human whole blood, serum or plasma to be captured and visualized on a unique membrane. The simple test procedure involves adding the specimen to the device and allowing it to flow through the membrane. If the specimen contains the target antibodies or antigens, they are captured on the test membrane and can be visually interpreted immediately after the addition of a detection reagent. Our technology platform is unique in its ability to detect multiple biomarkers specific to several diseases using a single cartridge. Our Multiplo line of rapid tests for HIV, Hepatitis B and C, and syphilis uses the platform's advanced capabilities to deliver up to four test results using one test cartridge and one drop of specimen.

Evaluation Criteria

THROUGHPUT:

Between 2 and 15 minutes for detection
Multiple samples, multiple tests/sample per run
95-32 samples every 2 hours
The system or approach is not amenable to full or semi-automation
Device or system is designed for a single use
0-1 solutions, buffer, eluents, and/or reagents
3 components
No set-up of the system is required
1-2 steps are required for detection

LOGISTICS:

Very brief (minutes-hours) training and minimal technical skills
Approximately the size of a soda can
Less than 1 kg
This system is not capable of transmitting data
There is no electrical requirement

OPERATIONS:

Can be used from 4°C to 41°C
Components must be stored at room temperature (27°C)
Performance is not influenced by relative humidity
Between 1 to 3 years shelf life
The system is not capable of autonomy

DETECTION:

Efforts are underway to achieve FDA approval
Less than 50 µL
Excellent specificity. System has occasional false alarms under certain conditions (<2%)
Manual kit not integrated with the system handles spore lysis

Tier Selection