EQA program for the TB-LAMP solution established
10/28/2020
Wiesbaden, Germany and Johannesburg, South Africa 01 October 2020 - Human Gesellschaft for Biochemica und Diagnostica (HUMAN) and SmartSpot Quality (SmartSpot) Successful implementation of an External Quality Control Program for TB-LAMP an ideal solution for applications in remote settings.
From now on it will be possible to verify the functionality of the HumaLoop T, the reagents as well as the laboratory procedures with blinded controls for External Quality Assessment (EQA) and unblinded controls for Verification.
Verification and EQA programs are essential for identifying errors and their causes as early as possible so as to initiate appropriate corrective actions to ensure the accuracy of future testing. By partaking in SmartSpot’s Verification and EQA programs, participants, and the patients they serve, can have the highest possible level of confidence in their results.
The SmartSpot patented technology enables the packaging of inactivated Mycobacterium tuberculosis on a simple spot on a card, which is easily and safely tested like a patient’s clinical specimen. Each card weighs less than 3g, is easy, safe and cost-effective to transport, and is stable for 24 months at ambient temperatures. SmartSpot designs controls for both Verification and EQA.
Verification
involves testing 8 standardized controls on a diagnostic instrument to ensure that it is fit-for-purpose before clinical specimens are to be tested.
EQA
is designed to ensure on-going quality monitoring of diagnostics, from pre-analytical to post-analytical processing. The EQA program consists of 3 test events per year whereby 4 controls are tested per event. As the SmartSpot quality controls are stable for 24 months, all controls that are required for the year are delivered in a single shipment, reducing shipping costs by 67%.
About TB-LAMPThe TB-LAMP solution, developed by HUMAN´s partner Eiken Chemical Co., Ltd., is a molecular method for the detection of Mycobacterium Tuberculosis Complex. Its robustness, high sensitivity and ease of use makes LAMP an excellent and nearly failsafe solution to improve TB diagnostics in remote areas. Moreover, this system offers a higher throughput of samples in a shorter time than existing technologies (1-2 hrs for 14 samples, up to 70 samples/day/equipment). In 2016, WHO* recommended that smear microscopy may be replaced by TB-LAMP. TB-LAMP is also included in the Global Drug Facility (GDF) catalog (http://stoptb.org/gdf/drugsupply/drugs_available.asp) and in the list of WHO recommended diagnostic tool 2018.
For more information about TB-LAMP, please visit www.human.de/lamp.
About SmartSpot
Since the onset of widescale molecular testing for TB in 2010, SmartSpot has been developing controls to meet the quality needs of TB molecular laboratories across the globe. SmartSpot Quality is a South African based private company which started in 2010 as a research program at the Department of Molecular Medicine and Haematology (DMMH) and the Centre of Excellence for Biomedical TB Research (CBTBR) at the University of Witwatersrand. Global demand for the SmartSpot controls required scaled up production and as such the University registered SmartSpot Quality (Pty) Limited as a company to execute this role. SmartSpot has been granted an exclusive license to the patented technology and the University departments have continued to improve the technology as well as adapt it to develop controls for additional diseases. In 10 years, SmartSpot has developed a global footprint in 30 countries providing Ministries of Health, Clinical Trial Units and private laboratories with quality control solutions. SmartSpot is the largest commercial supplier of molecular TB controls and provides a companion diagnostic for qualifying the accuracy of molecular diagnostic tests including TB, HIV, SARS-CoV-2, and soon MRSA and HCV.
For more information about SmartSpot, please visit www.SmartSpotQ.com.
About HUMAN
HUMAN, founded in 1972, is a Germany based privately owned company which develops, manufactures and distributes a wide range of IVD Diagnostics and laboratory equipment. The comprehensive portfolio of more than 400 products covers almost all areas of the modern laboratory, including Autoimmune and Molecular Diagnostics. With its strong network of partners in 160 countries and with six regional offices around the globe, HUMAN maintains probably the broadest distribution and service network, especially in developing and emerging countries.
