Updated on February 15, 2024

·

Created on July 27, 2017

Jana Care Aina

Upcoming Update

Aina is a diagnostic device on smartphones that can analyzes HbA1c, blood glucose, hemoglobin, creatinine, and lipids from a capillary blood sample.

Developed By
  1. Jana Care Inc.
Tested By
  • Jana Care Inc.
Content Partners
Unknown

Author

Product Description

Aina is a diagnostic sensor and smartphone application that plugs into any smartphone and analyzes HbA1c, blood glucose, hemoglobin, creatinine, and lipids from a capillary blood sample in only minutes. The device can be used by patients for self-monitoring as well as by healthcare providers for mass screening and point-of-care testing.

Aina has also developed the Habits Program, based on the landmark Diabetes Prevention Program, to deliver digital coaching and support to patients recently diagnosed with pre-diabetes or type II diabetes. The user can also visit Jana care’s desk support

Target SDGs

SDG 3: Good Health and Well-Being

Market Suggested Retail Price

$50.00

Market Suggested Retail Price (Secondary Currency)

$1.00

Target Users (Target Impact Group)

Household, Small and Medium-sized Enterprises, Public Sector Agencies

Distributors / Implementing Organizations

The manufacturer distributes his own product, Hospitals like Narayana Health Hospital in Bangalore, India are implementing the product

Competitive Landscape

Direct competitors include PATH: Strip test for gestational diabetes.

Manufacturing/Building Method

The product is also Mass Produced. The company is headquartered in Boston with an ISO13485 certified manufacturing site in India

Intellectural Property Type

Patent

User Provision Model

Patients can procure the Jana Care Aina from health clinics and hospitals or purchase  it directly from the manufacturer and download the companion app from the Google Play or the Apple Store. The healthcare workers also use the device to directly test patients.   Customers can also request a demo from the manufacturers website

Distributions to Date Status

50,000 patients in India as of February 2017.

Consumables

Testing strips

Detection sensitivity

Unknown

Indispensable equipment for function (Y/N)

Y

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

Y

Number of Tests Performed

6

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

Smartphone battery

Battery: 1x 1.5V AAA Battery
Battery Life of at least 200 Tests

Time required for procedure (minutes)

Approximately 3 minutes

Design Specifications

The Jana Care Aina Device is a blood glucometer that uses existing colorimetric test strips and plugs into any smartphone via the headphone jack. Blood readings are communicated to an accompanying mobile app, which allows pre-diabetic users to monitor consistently their glucose levels as well as weight, food intake, and physical activity. The product works with iOs and Android devices. The Aina device HbA1c test utilizes a method called  boronate affinity. The Aina HbA1c Test Kit consists of test strips, reagents, wash buffers, capillary tubes for collection of samples, and pipette tips. The reagent contains a lysing agent and a blue boronic acid conjugate. When blood is added to the reagent, the erythrocytes are lysed and all hemoglobin precipitates. The boronic acid conjugates binds to the glycosylated hemoglobin. An aliquot of the reaction mixture is applied to the test strip and all the precipitated hemoglobin, conjugate-bound and unbound, remains on top of the filter. Any unbound boronate is removed with the wash buffer. The precipitate is evaluated by measuring the blue (glycosylated hemoglobin) and the red (total hemoglobin) color intensity
respectively with the Aina Device, the ratio between them being proportional to the percentage of the glycosylated hemoglobin in the sample.
  The product has the following technical specifications Dimensions: 79.57 (L) X 36.54 (B) X 16.40 mm (H) Weight: 0.021kg (without battery), 0.032 kg (with battery) Power Requirements: 1.5V AAA battery Safety: Battery powered device, tested for compliance with EN 61010-1, EN 61010-2-101 and RoHS EMC Emissions/Immunity: Aina Device complies with applicable EMC emission requirements as per EN 61326-1:2013 and EN 61326-2-6:2013

Product Schematics

Technical Support

Users can be supported through the habits App. The user can also visit Jana care's desk support    

Replacement Components

Single-use test strips

Lifecycle

The test strips are single-use. Aida device lifecycle is unknown.

Manufacturer Specified Performance Parameters

Goals: - Early detection for diabetes, pre-diabetes and other chronic diseases - In point diagnostics and monitoring - Easy to use - Low cost

Vetted Performance Status

Method comparison to a YSI 2300 analyzer with 750 patient blood samples shows that the Jana Care Aina conforms with accuracy and repeatability requirements specified by ISO 15197:2013 standard (In vitro diagnostic test systems — Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus). Additional test results can be found in the Analytical Performance Summary.

Safety

The device is tested for compliance with EN 61010-1, EN 61010-2-101 and RoHS It is important to make sure hands and device are clean before use in order to prevent infection.

Complementary Technical Systems

Smartphone, testing strips, the Jana Care Habits app

Academic Research and References

Clarke, W. L., Cox, D., Gonder-Frederick, L. A., Carter, W., & Pohl, S. L. (1987). Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes care10(5), 622-628.

Bloom, Sonali., “Jana Care – Revolutionizing Diabetes Diagnosis and Treatment through Accessible Mobile Technology“, Digital Innitative, Harvard Bussiness School, 2015

RocketReach, “Jana Care Information

Sidhant Jena and Michael Depa, “Portable medical diagnostic systems and methods using a mobile device“, US9241663B2, U.S. Patent, 2015

EPAM CONTINUUM, “JANA CARE: AINA DEVICE“, 2016

Jana Care Inc. “Indications of Use“, Food and Drug Administration, DEPARTMENT OF HEALTH AND HUMAN SERVICES, 2020

Cabrera, Marquis. “Harvard Grads Develop Tech to Help Patients Better Manage Diabetes in India“, Huffpost, 2016

Jana Care, “AINA: Analytical Performance Summary

Lavakare, Jyoti. “Jana Care: Sidhant Jena’s start-up develops lifestyle app to help manage ‘diabesity’ “, The Economic Time, 2014

Jana Care, “AINA: Introdution

Jana Care, “AINA: User Manual

Compliance with regulations

Aina's accuracy meets ISO15197:2013 regulatory standards needed for CE and US FDA approval.

Evaluation methods

Jana Care has conducted trials with Mass General Hospital, the National University Hospital,  Xiangya Hospital, Changsha, China and others.

Other Information

The device also docks with the Aina Station, a point-of-care platform that can sit in a primary care office or clinic to screen patients with the goal of reduce time that patients have to wait for results from a central lab.

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