Gazelle Diagnostic Device

Target SDGs

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)

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

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