Response Biomedical RAMP 200, User Manual

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The RAMP® 200 is a system comprised of two primary components:

A Test Module (TM) that analyzes sample tests.

A Control Module (CM) that manages the sample test results that it receives from the TM.
Calibration and expiration information for Test Cartridges are uploaded to the CM through Lot Cards
that are included with the Test Kits.
To perform a Test, add a sample into the well of a Test Cartridge and then insert the Test Cartridge into
the TM. Once the Test Cartridge has been inserted, no further intervention is required. A barcode on the
bottom of the Test Cartridge is then read by the RAMP® 200 to determine the lot number. Information
loaded with the Lot Card identifies lot-specific parameters and expiration date. This ensures that an
expired cartridge cannot be used.
Analysis time is analyte-specific and typically takes approximately 15 minutes per sample. Analysis
results may be viewed on the RAMP® 200 display screen and/or output to a USB flash drive, computer or
network server, or printer.
The RAMP® 200 can be operated in either local (manual transfer) or network (auto transfer) mode.
Interaction with the RAMP® 200 is through its touchscreen display and user input is accepted from
either the touchscreen keyboard or an optional barcode scanner. Stored data, including results, can be
transferred via USB flash drive, sent to a printer or uploaded to a computer network.
The measurement process is based on the use of antibodies, biologically-derived binding agents that can
be used to specifically identify and bind to target analytes (e.g., analyte indicative of cardiac damage).
The RAMP® 200 Platform consists of two components: a disposable Test Cartridge that houses an
analyte specific immunochromatographic strip and a portable fluorescence analyzer. A "sandwich"
immunoassay format is followed. Target-specific antibodies are used to tag fluorescently labeled latex
particles. In addition, target-specific antibodies are immobilized at the detection zone of the
immunochromatographic strip. The RAMP® 200 also incorporates a quantitative Internal Standard that
is run and measured concurrently in every test. In a typical test, the operator adds sample, and antigen-
bound fluorescent particles are captured at the detection zone (i.e., the antigen is "sandwiched"
between the detection zone antibodies and the antibodies on the latex particle) and a portion of excess
particles that are not bound to antigen and do not bind at the detection zone are captured at the
control zone. The instrument measures fluorescence emitted by the complexes captured in the
detection and control zones and calculates a ratio between these measurements. The more analyte
present in the sample, the greater the number of antibody-binding sites that will be occupied, and
correspondingly, a greater number of fluorescently-labeled latex particles will be captured at the
detection zone.