Reducing import dependence on immunoassays

i1000

Agappe has recently launched cutting-edge CLIA system with 180-tests throughput, branded as i1000. After receiving patronage of customers for over 27 years in the IVD segments, such as biochemistry, hematology, immunochemistry, urine, molecular diagnostics, etc., this major foray into higher-end Immunology systems further boosts Agappe’s dominant position among Indian IVD companies.

Agappe has acquired a manufacturing license from CDSCO for CLIA reagents. In the first phase, already over 35 key parameters are available. The company has R&D and manufacturing geared up to add another 100 parameters. These will make Agappe range unarguably the most comprehensive one in CLIA in the Indian IVD market.

Current offerings include the most frequently used panels, such as hormone and fertility, infectious panels, cancer indicators, thyroid panels, metabolic panels, etc. High quality and affordability are the hallmarks of these reagents as our esteemed customers are experiencing them.

Numerous technological obstacles have been overcome in the indigenous development of these parameters, making it possible to successfully contribute to the admirable concept of Atmanirbhar Bharat. Agappe is now the proud owner of an AMH assay that has the best open vial stability, the quickest testing times, and the smallest sample volumes among all CLIA platforms.

For all these years, both CLIA equipment and reagents have been imported into India. Agappe now plans to reduce the import dependence and improve the patients’ access to technology at reasonable costs, and offer convenient pack sizes to the labs.

The magnetic microparticles-based Acridinium Ester (AE) direct chemiluminescence technology is used by the i1000 automatic CLIA system. It is apt for the laboratories due to its consistent performance, 180 test capacity, quick turnaround of reports, easy and convenient operations, and accurate results. The architecture of the i1000 might enable large hospitals’ assay needs and STAT tests in addition to meeting the needs of medium and small hospitals/labs for routine tests. High accuracy of the results is made possible by the compatible reagent sets and well-defined traceability system.

With the support of 30 reagent positions and 50 sample loading capacities simultaneously, the i1000 CLIA analyzer can process 180T per hour. For the initial test result, it takes 14 minutes to test cardiac parameters and 28 minutes to test all other parameters. Reagent vials with RFID integration enable an error-free reagent-management system. Each test is handled by a sophisticated cuvette-handling system employing disposable cuvettes with barcode assistance.

The main cause of immunoassay result discrepancies is insufficient sample volume. When the sample is introduced to the cuvette first, there is no reagent loss in the case of insufficient sample volumes. Unlike many other equipment with segmented cuvettes, where unused trash cuvettes may incur greater expenses, individual cuvette-type instrumentation ensures lower recurring costs in the case of low workloads. The i1000 user can run more samples per run and save time by randomly placing emergency samples. With online reagent substitution and more tests per batch, i1000 users can save time. The i1000 enjoys greater result precision with the minimum impact of interference factors and the lowest recurrent costs with defined traceability system and less frequent replenishment of consumables. It also saves space and money on substrate storage.

Agappe CLIA reagents are available in 1×100 T packs with integrated RFID and two-point calibrators. The package comes with the calibrators and there is enough volume for five calibrations to meet the 35-day stability requirement for open vials. There are various pack sizes for the mono- and multi-analyte controls. The reagents can be tracked against external quality-assurance programs too.

Agappe manufactures and markets a wide range of IVD equipment and reagents in its world-class manufacturing facilities integrated with one of Asia’s largest sophisticated warehouses and cold rooms. Agappe has an equal number of service personnel as sales to ensure the Industry best uptimes to its customers. Agappe now makes for the world, exporting its products to over 90 countries.