Product Overview
The RAMP® RSV Test is a qualitative fluorescent immunochromatographic assay for the detection of respiratory syncytial virus (RSV) F-protein antigens. It is intended to aid in the rapid diagnosis of RSV infection in symptomatic patients 21 years of age and younger.
The assay accepts nasal wash or aspirate, nasopharyngeal aspirate and nasopharyngeal swab specimens. After the prepared cartridge is inserted, the RAMP 200 provides an objective positive or negative result in approximately 15 minutes. Instrument-based interpretation helps standardize result reading and supports electronic data capture.
Important: A negative result is presumptive, does not exclude RSV infection and must not be used as the sole basis for treatment or other patient-management decisions. The FDA review recommends confirmation of negative results by cell culture or direct specimen fluorescence assay (DSFA). This prescription-use test is intended for professional use. Follow the current Instructions for Use and your laboratory’s procedures.
Approximately 15 Minutes
The RAMP 200 analyzes the prepared cartridge and reports an objective qualitative result.
Three Specimen Options
Validated for nasal wash or aspirate, nasopharyngeal aspirate and nasopharyngeal swab specimens.
Objective RSV Result
The reader evaluates fluorescence at the detection and internal-standard zones and reports positive or negative.
Key Features
- Qualitative detection of RSV F-protein antigens
- Aids in the rapid diagnosis of RSV infection in symptomatic patients 21 years of age and younger
- Accepts nasal wash or aspirate, nasopharyngeal aspirate and nasopharyngeal swab specimens
- Objective positive or negative result in approximately 15 minutes
- Fluorescent immunochromatographic method with an internal-standard zone
- Instrument flags invalid tests when sample migration or the internal-standard signal is inadequate
- Compatible only with the RAMP 200 Reader for the U.S. cleared configuration
- Lot-specific information is loaded into the instrument by lot card
- Twenty-five single-use tests per kit
- Prescription-use test intended for professional use
Product Specifications
| Jant Catalog Number | MDC1106 |
|---|---|
| Manufacturer Catalog Number | C1108 |
| Product | RAMP RSV Test Kit |
| Method | Qualitative fluorescent immunochromatographic assay |
| Target | RSV F-protein antigen |
| Clinical Use | Aids in the rapid diagnosis of RSV infection in symptomatic patients 21 years of age and younger |
| Specimens | Nasal wash or aspirate, nasopharyngeal aspirate and nasopharyngeal swab |
| Result | Qualitative positive or negative |
| Instrument Time | Approximately 15 minutes after cartridge insertion |
| Kit Size | 25 tests |
| Core Kit Configuration | 25 pouches, each containing one RAMP test cartridge and one test tip, plus 25 RAMP buffer vials; refer to current labeling for all supplied accessories |
| Storage | Store unopened at 15–30°C (59–86°F); do not freeze |
| Compatible Instrument | RAMP 200 Reader |
| Regulatory / Use Status | FDA 510(k) cleared under K091235; prescription use; for professional use |
RAMP RSV Testing Workflow
Prepare the Specimen
Collect and prepare an approved respiratory specimen using the materials, transport medium and timing specified in the current IFU.
Mix and Apply
Mix the respiratory specimen with RAMP buffer and the assay tip, then transfer the prepared sample to the cartridge as directed.
Insert and Read
Insert the cartridge into the RAMP 200. The reader analyzes the test and reports an objective qualitative result in approximately 15 minutes.
This workflow is a summary and is not a substitute for the complete Instructions for Use. Qualified personnel must follow the current IFU and laboratory procedures.
Designed for the RAMP 200 Platform
The RAMP 200 uses fluorescence readings from the assay’s detection and internal-standard zones to calculate a RAMP ratio and determine a positive or negative RSV result. The instrument can flag an invalid test when sample migration or the internal-standard signal is inadequate.
The RAMP 200 system and specimen-collection materials are not included with the RSV test kit and must be ordered separately unless specifically included in the quotation.
See the RAMP Platform
Watch the current RAMP system video, then review the assay IFU before performing patient testing.
Explore Respiratory Testing Options
Compare available testing formats based on patient population, specimen type, workflow and regulatory requirements.
RSV Tests
Review Jant’s available RSV testing products and select the format that fits your setting.
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Respiratory Testing
Browse Jant’s broader respiratory infectious-disease testing portfolio.
Documentation and Resources
FDA 510(k) Review - RAMP RSV Assay Multicenter Clinical Performance Study - PubMedContact Jant Pharmacal for the current RAMP RSV Instructions for Use and other product documentation.
Important Test Information
- For in vitro diagnostic use, prescription use and professional use.
- The cleared intended-use population is symptomatic patients 21 years of age and younger.
- Use only the specimen types and collection, transport and handling procedures specified in the current IFU.
- A negative result is presumptive, does not exclude RSV infection and must not be used as the sole basis for treatment or other patient-management decisions.
- The FDA review recommends confirmation of negative results by cell culture or direct specimen fluorescence assay (DSFA).
- Positive and negative predictive values depend on disease prevalence, specimen collection, handling and timing.
- Use the test only with the RAMP 200 Reader and follow all current quality-control requirements.
Frequently Asked Questions
The assay detects RSV F-protein antigens and reports a qualitative positive or negative result.
The test is intended to aid in the rapid diagnosis of RSV infection in symptomatic patients 21 years of age and younger. It is a prescription-use test intended for professional use.
The cleared specimen types are nasal wash or aspirate, nasopharyngeal aspirate and nasopharyngeal swab. Follow the current IFU for approved collection devices, transport media, handling and timing.
The instrument analyzes the prepared cartridge for approximately 15 minutes. Sample collection and preparation add time to the complete workflow.
The RAMP RSV Test is used with the RAMP 200 Reader. The analyzer is ordered separately unless specifically included in the quotation.
A negative result is presumptive and does not exclude RSV infection. It must not be used as the sole basis for treatment or other management decisions. The FDA review recommends confirmation of negative results by cell culture or direct specimen fluorescence assay.
The current FDA device record identifies 25 pouches, each containing one single-use RAMP test cartridge and one test tip, plus 25 RAMP buffer vials. Confirm all supplied accessories against the current product labeling.
The current FDA device record specifies storage at 15–30°C (59–86°F). Do not freeze. Always verify storage instructions on the received kit and current IFU.
Ordering Information
To place an order or request information, call Jant Pharmacal at 800.676.5565
| Catalog Number | Description | Unit of Measurement |
|---|---|---|
| MDC1106 | RAMP RSV Test | 25 tests/kit |
The RAMP 200 Reader and specimen-collection materials are required and ordered separately unless specifically included in the quotation.