RAMP NT-proBNP Test

RAMP NT-proBNP quantitative whole-blood test kit

The RAMP® NT-proBNP test is an accurate, quantitative and rapid diagnostic test that aids in the diagnosis and assessment of severity in individuals suspected of having congestive heart failure (CHF) and can aid in the risk stratification of patients with heart failure.  The RAMP® NT-proBNP test is ideally suited for point of care testing and laboratory use by healthcare professionals.

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Product Overview

The RAMP® NT-proBNP Test is an FDA-cleared quantitative immunochromatographic assay for measuring N-terminal pro-B-type natriuretic peptide (NT-proBNP) in EDTA whole blood. Measurement of NT-proBNP aids in the diagnosis and assessment of severity in individuals suspected of having heart failure and may aid in the risk stratification of patients with heart failure.

The assay uses 75 µL of EDTA whole blood and provides a quantitative result in approximately 15 minutes on a compatible RAMP instrument. Each kit contains 25 single-use test cartridges, test tips and buffer vials, together with a calibrated transfer device and lot card.

Important: The RAMP NT-proBNP Test is for in vitro diagnostic use and must be operated in a laboratory setting when used with the RAMP 200. Results must be evaluated together with the patient’s medical history, clinical examination and other findings. Review the complete Instructions for Use before testing.

Approximately 15 Minutes

The compatible RAMP instrument analyzes the prepared cartridge and reports a quantitative result.

75 µL Whole-Blood Sample

The assay uses EDTA whole blood. Other specimen types and anticoagulants have not been evaluated.

25 Tests per Kit

Single-use cartridges, test tips and buffer vials are supplied with the transfer device and lot card.

Key Features

  • FDA-cleared quantitative immunochromatographic assay
  • Measures NT-proBNP in EDTA whole blood
  • Aids in the diagnosis and assessment of severity in individuals suspected of having heart failure
  • May aid in the risk stratification of patients with heart failure
  • 75 µL sample volume using the calibrated transfer device included with the kit
  • Quantitative results in approximately 15 minutes
  • Measurement range of 27–22,000 ng/L
  • Lot card stores the lot number, expiration date and standard-curve information
  • No additional user calibration beyond loading the lot card for each new test-kit lot
  • Built-in cartridge controls and instrument self-diagnostic functions
  • Compatible with the RAMP Reader or the modular RAMP 200 system specified in the IFU

Product Specifications

Jant Catalog Number MDC1105
Product RAMP NT-proBNP Test
Method Quantitative immunochromatographic fluorescent assay
Analyte N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Specimen EDTA whole blood only; plastic K2EDTA tubes are recommended
Sample Volume 75 µL
Time to Result Approximately 15 minutes
Measurement Range 27–22,000 ng/L
Limit of Detection 34 ng/L
Limit of Quantitation 57 ng/L at 20% CV
Kit Contents 25 cartridges and test tips, 25 buffer vials, one 75 µL transfer device, one lot card and one IFU
Storage 2–8°C; do not freeze. Refer to the IFU for permitted room-temperature storage.
Compatible Instruments RAMP Reader or RAMP 200 control unit with test module, as specified in the IFU
Regulatory Status FDA cleared; for in vitro diagnostic use; prescription use

RAMP NT-proBNP Testing Workflow

1

Prepare

Bring the kit components to room temperature and thoroughly mix the EDTA whole-blood specimen according to the IFU.

2

Mix and Apply

Use the supplied transfer device to mix 75 µL of specimen with the buffer and apply the prepared sample to the cartridge.

3

Insert and Read

Insert the cartridge into the compatible RAMP instrument. The system analyzes the test and reports the result in approximately 15 minutes.

This summary is not a substitute for the complete Instructions for Use. Qualified personnel must follow the current IFU and laboratory procedures.

Published Method-Comparison Data


RAMP NT-proBNP and Elecsys method-comparison graph

Historical method-comparison graphic retained from the original Jant product page. Review the current Instructions for Use and the newer RAMP NT-proBNP method-comparison study below for study design, population, limitations and current performance information.

Designed for the RAMP Platform

The RAMP 200 is a modular, automated platform that supports multiple compatible cardiovascular assays. A control unit can be connected to as many as three dual-port test modules, allowing laboratories to run two, four or six tests simultaneously.

The NT-proBNP test kit contains the lot card needed to load lot-specific calibration information into the instrument. Test kits, controls and analyzer components are ordered separately unless specifically included in the quotation.

RAMP NT-proBNP Videos

Important Test Information

  • For in vitro diagnostic use and use by qualified personnel.
  • The RAMP NT-proBNP Test must be operated in a laboratory setting when used with the RAMP 200.
  • Use only EDTA whole blood. Other specimen types and anticoagulants have not been evaluated.
  • Follow the IFU for specimen timing, storage, preparation, testing and quality-control requirements.
  • Patient history, clinical examination and other findings must be assessed together with the test result.
  • Heterophilic antibodies and other unevaluated substances may interfere with immunoassay results.
  • Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

Frequently Asked Questions

The assay quantitatively measures N-terminal pro-B-type natriuretic peptide in EDTA whole blood. Its cleared intended use is described in the current Instructions for Use.

Measurement of NT-proBNP aids in the diagnosis and assessment of severity in individuals suspected of having heart failure and may aid in the risk stratification of patients with heart failure. Results must be interpreted with clinical findings and other diagnostic information.

The test requires 75 µL of EDTA whole blood. Plastic K2EDTA collection tubes are recommended. Other sample types and anticoagulants have not been evaluated.

The compatible RAMP instrument reports the result in approximately 15 minutes after the prepared cartridge is inserted.

The IFU specifies the RAMP Reader or the RAMP 200 control unit with a compatible test module. View the RAMP 200 system page for platform information and request a quote for the required configuration.

Each kit contains a lot card with the test-lot information and standard curve. No additional calibration is required beyond loading the lot card for each new test-kit lot.

RAMP Cardiac Controls are available for supported cardiac assays. Laboratories should follow the assay IFU and applicable federal, state, local and accreditation requirements for quality-control testing.

One MDC1105 kit contains 25 individually pouched test cartridges and test tips, 25 buffer vials, one calibrated 75 µL transfer device, one lot card and one Instructions for Use document.

Ordering Information

To place an order or request information, call Jant Pharmacal at 800.676.5565

Catalog Number Description Unit of Measurement
MDC1105 RAMP NT-proBNP Test 25 tests/kit

A compatible RAMP instrument and applicable quality-control materials are required and ordered separately unless included in the quotation.