Response Biomedical RAMP READER - 1.0 Introduction; 1.1 Overview; 1.2 Intended Use; 1.3 RAMP System Description

Operator’s Manual, RAMP
®
Reader 1
1.0 INTRODUCTION
1.1 Overview
The RAMP
®
System is a rapid, quantitative immunochromatographic system for performing in vitro
diagnostic analyses on a variety of analytes. The System can be used for various applications, from
use in a clinical setting (point-of-care, central or STAT laboratory) to use for onsite screening of
environmental samples.
The System is comprised of the RAMP
®
Reader (“Reader”) and various RAMP
®
Assay/Test kits
(“Kits”). Optional accessories include a barcode wand, printer, and cabling required to connect the
Reader to a computer, printer or another Reader. Calibration and expiration information for Kits are
input to the Reader through Lot Cards enclosed with the Kits. The Reader only accepts Kits that are
designed specifically for use with this instrument.
To perform a test, the operator prepares the appropriate sample according to the Test Kit Instructions
for Use, places an aliquot of the sample into the sample well of the Test Cartridge and inserts the
Test Cartridge into the Reader.
Once the Cartridge has been inserted, no further intervention is required. A barcode on the bottom of
the Cartridge is read to determine the Kit lot number. Information loaded with the Lot Card identifies
lot-specific parameters and expiration date. This ensures that an expired Cartridge is not used.
Analysis time is analyte-specific and averages 15 minutes across Assays (Test-dependent). Results
may be viewed on the Reader LCD screen and/or output to a printer or computer. Operator input is
accepted from the Reader’s keypad or an optional barcode wand.
The RAMP
®
System should only be used by trained personnel.
1.2 Intended Use
The RAMP
®
Reader is a general use fluorometer that analyzes results produced by immunoassays
manufactured by Response Biomedical Corp.
1.3 RAMP
®
System Description
Each disposable, single-use Test Cartridge houses an analyte-specific, immunochromatographic strip
on which the Assay runs. The RAMP
®
System uses an internal calibrator incorporated into each test
strip to compensate for test-to-test variations.
To perform an assay, the operator transfers a sample into the sample well of a Cartridge and inserts
the Cartridge into the Reader. The sample is drawn by capillary action along the membrane. Analyte
present in the sample interacts and binds with the fluorescently-labeled antibodies forming an
antibody-antigen complex. The complexes and labeled antibodies are subsequently captured at the
detection and control zones. When the reaction in the Cartridge is complete, the Reader scans the
assay strip and detects fluorescence in the detection and the internal standard zones, then by
comparing fluorescence captured at the detection and internal standard zones, converts this ratio
(RAMP
®
Ratio) into an analyte concentration using lot-specific calibration data. Refer to Test Kit