Updated on February 26, 2024

·

Created on October 21, 2021

Gazelle Diagnostic Device

Upcoming Update

Gazelle diagnostic device is a non-invasive sickle cell and malaria diagnostic device

Developed By
  1. Hemex Health
Tested By
  • Case Western Reserve University
Content Partners
Unknown

Author

Product Description

Gazelle is a compact, rugged, and portable battery-operated point-of-care test diagnostic device for anemia and sickle cell disease (SCD) with results in just minutesThere are two variants of the device, the Gazelle Hb Variant and the Gazelle malaria. A commercialized tool for anemia is being developed with the goal of a one-minute 25-cent noninvasive diagnostic tool for screening anemia, malaria, and SCD using an optical finger sensor. 

Target SDGs

SDG 3: Good Health and Well-Being

Market Suggested Retail Price

$1,200.00

Market Suggested Retail Price (Secondary Currency)

$1.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies

Distributors / Implementing Organizations

The product is distributed by the following institutions: Hemex Health, HemexDx  Case Western Reserve University, Novartis Biome,Tata Elxsi, Bio-Rad Laboratories   

Competitive Landscape

Direct competitors include HemoCue WBC DIFF System.

Manufacturing/Building Method

The device is manufactured at Robonik India. The cartridges are manufactured at Lakshmi Lifesciences, Coimbatore.

Intellectural Property Type

Patent

User Provision Model

The product can be directly ordered from the manufacturer or other distributors like EHACLINICS

Distributions to Date Status

As of 2021, 300 Gazelle’s devices have been distributed to date. (Interview with representative)

Consumables

Cartridges, Pipette with tips, Eppendorf tubes. Interview with representative

Detection sensitivity

The Gazelle tests outperformed Rapid Diagnostic Test (RDT) for P. Vivax Malaria with sensitivity of 96.2%  versus 83.9% for current RDTs as reported in a malaria journal

Indispensable equipment for function (Y/N)

Yes

Maintenance or calibration required by user at time of use? (Y/N)

No

Number of Tests Performed

35 – 40 samples per day

Power supply type: Continuous, Recharging only (V, time required, battery life), Other

 Designed with an in-built battery that can be recharged to run the whole day

Time required for procedure (minutes)

8 minutes

Design Specifications

The 3.5 kg portable device operates on the Magneto-Optical Detector (MOD) which works by detecting a  byproduct of malaria infection in a drop of blood.  When malaria parasites consume red blood cells, they create paramagnetic iron-containing crystals called hemozoin inside red blood cells as shown below. The magneto-optical sensors in the reader measure hemozoin levels. In the case of sickle cell, the reader uses microchip electrophoresis to identify and quantify hemoglobin levels in a blood sample inserted into a cartridge that goes directly into the reader. The device is designed with an in-built battery that can be recharged to run the whole day using an android phone charger. The device can run about 35 to 40 samples a day. Mechanism of hemozoin detection by MOD

Product Schematics

Technical Support

The technical support is provided by the manufacturer and distributors like EHACLINICS

Replacement Components

There are no replacement components for the device. The device is not to be serviced in the field. Interview with representative

Lifecycle

5 years Interview with representative

Manufacturer Specified Performance Parameters

The manufacturer has the following specified targets: lightweight, transportable, battery-powered, designed for most extreme environments, designed with no cold chain requirements, cloud-based storage  

Vetted Performance Status

Gazelle has a CE Mark and regulatory approval in India and Ghana after its sickle cell disease test with other registrations pending. The Gazelle Malaria test outperformed Rapid Diagnostic Tests (RDTs) in sensitivity tests in detecting Plasmodium vivax (P. vivax) malaria.

Safety

Users are advised to be careful when handling patient blood samples. Interview with representative  

Complementary Technical Systems

The Gazelle cloud application stores over 2500 patient reports that can be viewed onscreen or sent to a connected printer. Users can download the reports to a USB drive for transfer to a personal computer.

Academic Research and References

N. Hasan, A. Fraiwan, J. A. Little and U. A. Gurkan, 2017, A low-cost, mass-producible point-of-care platform for diagnosing hemoglobin disorders, 2017 IEEE Healthcare Innovations and Point of Care Technologies (HI-POCT), pp. 164-167

Rajat Kumar et al., 2020, First successful field evaluation of new, one-minute haemozoin-based malaria diagnostic device, EClinicalMedicine, Volume 22, pp. 10034

An, R., et al., 2021, Emerging point-of-care technologies for anemia detection, Lab Chip, 221, pp.1843-1865

Datta, Jyothi, “HemexDx’s one-minute, low-cost test for malaria undergoing regulatory review“, The Hindu Businessline, 2020

The Daily, “A new weapon in the fight against sickle cell disease“, Case Western Reserve University, 2020

TATA ELXSI, “a point-of-care diagnostic platform“, 20178

Hemex Health, “New Research Shows Gazelle Diagnostic Device Outperformed Rapid Diagnostic Test for P. Vivax Malaria, Detected Challenging Types of Malaria, and Provided Accurate Sickle Cell Disease Detection“, Yahoo!  Finance, 2020

Hemex Health, “Gazelle® Diagnostic Platform, Designed for Low Resource Settings, Integrates Miniaturized Technologies with AI to Transform Disease Screening and Diagnosis“, Globe Newswire, 2020

Cheney, Catherine, “Optimized for the underserved: A new diagnostic test built for low-income settings“, Devex, 2020

Sheon David, “Gazelle® Diagnostic Platform, Designed for Low Resource Settings, Integrates Miniaturized Technologies with AI to Transform Disease Screening and Diagnosis“, Case Western Reserve University, 2020

Christian Connections for International Health, “Sickle Cell Disease: New Solutions for Diagnosis and Management“, 2020

Compliance with regulations

Gazelle diagnostic device has regulatory approval in Ghana and India. The product also has a CE mark

Evaluation methods

Sensitivity and specificity testing:  A study conducted in the Brazilian Amazon on P. vivax showed that Gazelle was more sensitive than RDTs and comparable in accuracy to expert microscopy, but significantly faster than RDTs, microscopy and PCR as reported by Yahoo! finance

Other Information

The Battery-powered equipment that can run 200 tests independently

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