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  2. Product lines
  3. Molecular DX

Molecular DX

TB-LAMP and Malaria-LAMP: Fast, accurate and life-saving

Molecular diagnostics is one of the fastest-growing segments within in vitro diagnostics. It analyzes the genetic material of humans or pathogens to obtain clinical information related to diseases.

 

Our Molecular Diagnostics solutions are designed to provide high-quality, rapid, and reliable detection of infectious diseases.

 

Utilizing Loop-mediated Isothermal Amplification (LAMP) technology, our products deliver accurate results with minimal equipment needs, making them ideal for use in low-resource settings. 

In cooperation with our partner EIKEN CHEMICALS CO. LTD., HUMAN provides an innovative LAMP testing system for the screening of infections with bacteria belonging to the Mycobacterium Tuberculosis Complex (MTBC)  as well as for the Malaria screening (Malaria Pan, Malaria Pf and Malaria Pv) ideal especially in low prevalence areas.

 

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  • TB-LAMP used for screening infections caused by bacteria belonging to the Mycobacterium Tuberculosis Complex (MTBC). 
  • Malaria-LAMP to detect Plasmodium species, Plasmodium ovale, P. vivax, P. malariae, P. knowlesi ​​​​and P. falciparum.
fileFlyer TB-LAMPfileFlyer Malaria-LAMP

Loop-mediated isothermal amplification (LAMP)

Advanced molecular detection in 4 easy steps

Loop-mediated isothermal amplification (LAMP) is an accurate, simple, rapid and costeffective molecular method used for pathogen detection. It is characterized by the use of four different primers, which are specifically designed to recognize six distinct regions on the target gene and by a constant temperature during the amplification process. The formed dumbbell-like structures of the DNA provide an increased number of starting points for the DNA synthesis and thus offer a faster multiplication of the target gene. 

 

It enables the amplification at one temperature and the detection of target DNA.The amplified products are detected visually by reading green fluorescence or by the measurement of turbidity in real-time. 

 

Performing LAMP assays is straightforward and requires significantly less technical expertise compared to more complex molecular techniques like polymerase chain reaction (PCR). This allows healthcare workers with basic training to accurately perform the tests. 

 

Its robustness, high sensitivity, and ease of use make LAMP an excellent and nearly failsafe tool for improving diagnostics in remote areas. 


The entire workflow consists of only four major steps: the sample transfer and lysis, the DNA/RNA extraction with the help of the LoopampTM PURE DNA Extraction Kit , the loop-mediated isothermal amplification, and the result reading with the HumaLoop or the HumaTurb system.

 

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  4. Visually with HumaLoop T and HumaLoop M or by using the HumaTurb turbidimeter 

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TB-LAMP

Lighting the way to easier, faster, and more accurate Tuberculosis detection

Tuberculosis (TB) remains a major global health concern, with millions of new infections and deaths each year. Accurate and rapid diagnosis is critical for effective treatment and control.

 

WHO recommends TB-LAMP as an alternative for smear microscopy since 2016. Almost half of all positive TB cases are missed by smear microscopy.

 
The TB-LAMP (Loop-mediated Isothermal Amplification) test provides a fast, reliable, and affordable molecular method to detect Mycobacterium tuberculosis complex (MTBC) even in resource-limited settings. This cutting-edge technology delivers diagnostic results comparable to standard molecular methods, but with greater simplicity and ease of use.

  • High sensitivity and specificity: Accuracy equivalent to traditional PCR
  • Rapid detection: Results available within 1–2 hours
  • Simple Workflow: Requires minimal training and lab infastructure
  • Cost-Effective: TB-LAMP provides a low-cost alternative to other molecular TB detection methods
  • Increased accessibility even in remote areas: Portable and independent from mains

 

 

 

 

 

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For the TB-LAMP solution, additional services are available, such as DataToCare by Savics, a customizable suite of digital applications that streamline laboratory data collection and sharing. It connects national laboratory networks by capturing diagnostic and patient data at the facility level. Another service is SmartSpot Quality, an External Quality Control Program.

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    New connectivity solution for TB-LAMP helps reduce gap between diagnosis and treatment of TB patients

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    In cooperation between Savics and HUMAN, the TB-LAMP test system has been integrated into the DataToCare App. From now on, it is possible to store and send the results obtained with HumaLoop T electronically by mail or SMS. This provides access to highly professional patient management, even in remote areas. 
     

    With the majority of TB patients living in developing countries with little infrastructure, diagnosis and treatment of TB remains a major challenge. In particular, paper-based processes and lack of standardization and connectivity between laboratory systems are the main causes of communication gaps between patients and health care providers. Collaboration between health programs at the point of care and at the central level are also affected. 
     

    DataToCare is a fully customizable suite of integrated applications (mobile, desktop, web) that connects national laboratory networks by capturing diagnostic and patient data at the facility level. It displays real-time information on a dashboard to facilitate decision-making at the central level and notifies medical teams and patients of test results in a timely manner.

     

    The app allows users to create new patients, set up new test runs of TB-LAMP, save photos and assessment of the test result, and then send them directly to the MOH, physicians or patients via email or SMS.

     

    DataToCare is currently already in use in 14 countries: Benin, Burkina Faso, Cameroon, Central African Republic, DR Congo, Indonesia, Ivory Coast, Liberia, Mali, Morocco, Niger, Philippines, Togo and Zambia.

    The advantages of TB-LAMP integration in DataToCare at a glance:

    • Sending standardized test results & patient demographic data to the central server via internet or SMS when connectivity is not available.
    • Transparency by epidemiological, demographic, operational through tables, charts and maps.
    • Sending diagnostic test results via email and SMS to physicians and patients across multiple points of care.
    • Exportable and/or automatically generated case-based or aggregated reports at the laboratory, regional, and national levels
    • Providing devices usages statistics schedules & manages maintenance activities of diagnostic equipments

      >>  Brochure
      For more information and for implementation of the app please visit https://savics.org/

  2. EQA program for the TB-LAMP solution established

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    HUMAN and SmartSpot Quality successfully implemented an External Quality Control Program for TB-LAMP
    as 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 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

     

     

fileFlyer TB-LAMPfileGDF Technical Information NotefileFlyer DataToCare by Savicslink-externalThe Diagnostic Gap of TuberculosisglobeWHO: Recommended rapid diagnostic tests globeWHO: Access to rapid tuberculosis diagnostics

Two system solutions for various healthcare settings

HumaLoop T 

Easy to use LAMP technology for primary and district laboratories

The HumaLoop T is specifically designed as a consolidated platform for sample preparation, amplification, and easy visual result interpretation. The Loopamp™ MTBC Detection Kit enables sensitive and accurate molecular detection of the Mycobacterium tuberculosis complex, offering a valuable alternative to smear microscopy. The elimination of tuberculosis (TB) requires appropriate technology that can be utilized in rural and remote areas.

 

 

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  • Throughput: Up to 16 tests per run or up to 70 samples per day
  • Preinstalled settings: Fixed incubation times and temperatures for the
    Loopamp™ MTBC Detection Kit
  • Consolidated processing: Sample preparation, amplification, and detection on a single instrument
  • Optimized for remote use: Independent power solution available via solar panel and battery system
  • Clear result interpretation: Visual reading of fluorescence signals
  • Fast reporting: Results available within 1–2 hours
globeView productsplay-circleHumaLoop T Training video

HumaTurb C+A

Scalable LAMP system for reference and regional laboratories

The HumaTurb system enables real-time detection of turbidity based on magnesium pyrophosphate generated during the amplification process. This system consists of two parts: HumaTurb C and HumaTurb A. HumaTurb C manages the setup and controls the incubation time and temperature, while the amplification occurs in HumaTurb A. Sample lysis is handled by the HumaHeat incubator, which simplifies lysis using Loopamp™ heating tubes and a dedicated heating block.

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  • Throughput: Up to 96 tests per run if expanded with six HumaTurb A units
  • Versatile assays: Multiple Loopamp™ assays can be run simultaneously
  • Flexible data transfer: Includes USB connectivity
  • Convenient reporting: Built-in printer for automated result generation
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TB-LAMP Loopamp™ Detection Kits

Loopamp™ PURE DNA Extraction Kit
The procedure for Ultra Rapid Extraction (PURE) is a fast and efficient extraction method to obtain
highly pure DNA from patient samples. This kit supports up to 90 extractions

 

Loopamp™MTBC Detection Kit 
The Loopamp™ MTBC Detection Kit is a qualitative test for the detection of bacteria belonging to Mycobacterium Tuberculosis Complex (MTBC) in human sputum samples. The kit contains reagents for 96 reactions as well as positive and negative controls. Dried LAMP reagents are reconstituted with extracted DNA solution and incubated for 40 min at 67°C either in HumaLoop T or HumaTurb instruments.

 

Pipette-60 Set
Pipette to ease the transfer of sputum samples (1 x pipette and 4 x 96 filter tips)

 

 

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TB-LAMP - It's time for a change

The TB-LAMP workflow allows an easy DNA extraction and preparation of reaction mixes in a few steps with only a minimum of equipment and reagents. Reagent storage and shipment at room temperature as well as the excellent test performance make molecular pathogen testing available in rural areas with limited settings. Only lever to find the missing cases is the access to sensitive and reliable diagnosis. Therefore: TB-LAMP - It's time for a change!

  • company Institute Pasteur International
    testimonial flag

    Tuberculosis remains one of the major causes of death worldwide. In 2020, there were an estimated 9.9 million TB cases according to the WHO, of which about 1.5 million led to death. The majority of these cases occur in low- and middle-income countries. Most frightening, however, is the fact that of the estimated 9.9 million cases, about 4.1 million remain undetected. Gaps between the estimated number of new cases and the number actually reported are due to underreporting of cases detected and underdiagnosis or misdiagnosis. The reasons for that are manifold.

    Institute Pasteur International

    Dr. Valerie Flore Donkeng Donfack

  • company Department of Pathology and Microbiology University Teaching Hospital
    testimonial flag

    Current methods have their limitations. Microscopy provides only inaccurate results (low sensitivity) and requires two patient samples on two different days. Culture, the gold standard, offers better sensitivity and specificity, but the Patient often has to wait several weeks for its result, during which valuable time for treatment is lost. The best performance is achieved by molecular methods. In addition to a complex workflow and complicated evaluation of results, expensive equipment, air conditioning and a good infrastructure (continuous power with good quality, safety benches, etc.) are often required. These requirements are often not to be found or met in smaller and peripheral laboratories. The WHO therefore recommends TB-LAMP as an alternative to smear microscopy.

    Department of Pathology and Microbiology University Teaching Hospital

    Eddie Samuneti Solo

  • company EpiConsult Clinic & Diagnostic Centre Ltd.
    testimonial flag

    “TB-LAMP is a DNA-based method for quick TB diagnosis. It is fast, specific and has replaced microscopy because of its built-in heating block and UV light for reading sample results. It can be used in the remotest places because it's portable.”

    EpiConsult Clinic & Diagnostic Centre Ltd.

    Chinyere Obiejemba

  • company Baptist Hospital Mutengene
    testimonial flag

    “When I attended the training, I understood that TB-LAMP is beneficial for patients and technicians. Previously, the patient's first and second sputum was used in microscopy, but now, with the sensitivity of TB-LAMP, you only need to take the sputum once. With microscopy, it was difficult to handle 50 samples per day. This technique allows us to test 14 patients in one run and up to 70 in one day. For me, TB-LAMP is the best method for rapid detection of tuberculosis.”

    Baptist Hospital Mutengene

    Joel Wepngong Tabah, Laboratory Technician

  • company Dr. Lal PathLabs,
    testimonial flag

    “The high sensitivity, high throughput and the reliability of the assay, even under the challenging climate conditions, have convinced us. With this novel technology, we have the opportunity to find more tuberculosis cases than with traditional methods.”

    Dr. Lal PathLabs,

    Anupam Kumar

  • company HSC Nzagi
    testimonial flag

    “I like the HumaLoop T and the easy handling very much. As a journey from the capital Luanda to my lab takes about 3 days by road, it is especially important for us to have a reliable device that requires only a minimum service every 12 months.”

    HSC Nzagi

    Tiago TxaVunda, Laboratory Director

  • company Kangemi Health Center
    testimonial flag

    “We love using the new TB-LAMP technology: it is very quick and only takes about two hours for 14 samples per run. Thus a patient gets clarity on the same day whether he has TB or not. TB-LAMP provides very reliable results with a high sensitivity and specificity. Lastly, the HumaLoop T is a simple small machine which requires little infrastructure.”

    Kangemi Health Center

    Anderson Mugendi & Simon Chege, Laboratory Technicians,

Further informations about TB-LAMP

fileFlyer TB-LAMPfilePoster TB-LAMP WorkflowfileFAQ's TB-LAMPfilePublication ListfileGDF Technical Information Note
fileExperiences and Lessons LearnedfileWHO Policy Guidance TB-LAMPfileWHO: Essential In Vitro Diagnostics List
globeStop TB Partnership

Malaria-LAMP

Easily track down infections
even in low prevalence settings

Malaria continues to pose a significant global health threat, with millions of cases and deaths reported annually, particularly in resource-limited regions. Early and precise diagnosis is vital for prompt treatment and control measures. Microscopy and RDT’s are not able to track down parasites in low-transmission settings.

 

The Malaria LAMP (Loop-mediated Isothermal Amplification) test offers an innovative, rapid, and reliable molecular solution to detect Malaria Pan species (Plasmodium ovale, P. vivax, P. malariae, P. knowlesi ​​​​and P. falciparum) in human blood samples. This advanced technology delivers results comparable to traditional molecular methods while being easier to use and more accessible.

  • High sensitivity and specificity: 96–100 % and  97–100 %, detection limit of 1 parasite / μl
  • Rapid detection: Results available within 1–2 hours
  • Differentiation: between Plasmodium pan species, P. falciparum and P. vivax
  • Simple Workflow: Requires minimal training and lab infastructure
  • Cost-Effective: TB-LAMP provides a low-cost alternative to other molecular TB detection methods
  • Increased accessibility even in remote areas: Portable and independent from mains

 

 

 

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"Diagnostic testing and treatment Research is required to develop tools that can more readily detect low-level parasitaemia in asymptomatic carriers and ascertain the effectiveness of different screening strategies both at higher transmission levels, in order to appropriately target interventions, and when countries enter the elimination phase."
- WHO, Global Technical Strategy for Malaria 2016 – 2030, 2015 - 

fileFlyer Malaria-LAMPfileFAQsfilePublication List
link-externalSmall Bites, Global Threat, Diagnostic Challengelink-externalImplementation of Malaria-LAMP in Senegal

Two system solutions for various healthcare settings

HumaLoop M 

Easy to use LAMP technology for primary and district laboratories

The HumaLoop M is specifically designed as a consolidated platform for sample preparation, amplification, and easy visual result interpretation. The Loopamp™ Malaria Pan, Malaria Pf and Malaria Pv Detection Kit enable

sensitive and accurate molecular detection and differentiation of asymptomatic, sub-microscopic infections.

 

 

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  • Throughput: Up to 16 tests per run or up to 70 samples per day
  • Preinstalled settings: Fixed incubation times and temperatures for the
    Loopamp™ MTBC Detection Kit
  • Consolidated processing: Sample preparation, amplification, and detection on a single instrument
  • Optimized for remote use: Independent power solution available via solar panel and battery system
  • Clear result interpretation: Visual reading of fluorescence signals
  • Fast reporting: Results available within 1–2 hours
globeView productsplay-circleHumaLoop M Training Video

HumaTurb C+A

Scalable LAMP system for reference and regional laboratories

The HumaTurb system enables real-time detection of turbidity based on magnesium pyrophosphate generated during the amplification process. This system consists of two parts: HumaTurb C and HumaTurb A. HumaTurb C manages the setup and controls the incubation time and temperature, while the amplification occurs in HumaTurb A. Sample lysis is handled by the HumaHeat incubator, which simplifies lysis using Loopamp™ heating tubes and a dedicated heating block.

asset_image

  • Throughput: Up to 96 tests per run if expanded with six HumaTurb A units
  • Versatile assays: Multiple Loopamp™ assays can be run simultaneously
  • Flexible data transfer: Includes USB connectivity
  • Convenient reporting: Built-in printer for automated result generation
globeView products

Malaria-LAMP Loopamp™ Detection Kits

Loopamp™ PURE DNA Extraction Kit
The procedure for Ultra Rapid Extraction (PURE) is a fast and efficient extraction method to obtain
highly pure DNA from patient samples. This kit supports up to 90 extractions

 

Loopamp™ Malaria Pan Detection Kit
Qualitative test for detection of Malaria Pan species (Plasmodium ovale, P. vivax, P. malariae and P. falciparum) in human blood samples. The kits contain reagents for 96 reactions or 480 reactions as well as positive and negative controls. 

Storage and shipment at 2...30°C.

 

Loopamp™ Malaria Pv Detection Kit

Qualitative test for detection of Plasmodium vivax species in human blood samples.
The kit contains reagents for 96 reactions as well as positive and negative controls.

Storage and shipment at 2...30°C.

 

Loopamp™ Malaria Pf Detection Kit

Qualitative test for detection of Plasmodium falciparum species in human blood samples.
The kit contains reagents for 96 reactions as well as positive and negative controls.

Storage and shipment at 2...30°C.

 

 

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Optional Accessories

TB-LAMP and Malaria-LAMP

HuMax ITA
Bench-top centrifuge with preinstalled program for the incubation
and mixing of LoopampTM reaction tubes

 

Solar Panel (100W)
Foldable solar panel for charging the battery system 


Portable Battery System (220V, 300W)
LAMP devices can be operated up to three runs 

 

 

 

 

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