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Molecular test - Loop-mediated Isothermal Amplification (“LAMP”)

What we can do to achieve universal health coverage (UHC)?
In 2015, Sustainable Development Goals (SDGs:17 Goals) are adopted at United Nations summit. In SDGs Goal 3; “Ensure healthy lives and promote well-being for all at all ages,” UHC is one of the targets to achieve.

Large global populations die of infectious diseases such as tuberculosis, malaria and Neglected Tropical Diseases (NTDs), and it is mandatory to improve the healthcare immediately, however, many high burden countries don’t have access to necessary healthcare because of poverty.

To achieve UHC, Eiken Chemical contributes to realize proper and early detection of infectious diseases by providing accurate, easy and robust LAMP products. LAMP products are designed for the resource limited setting use to reach the last mile of health for the people.

Now, it’s time to action for “No one left behind”.


Innovative Tool for TB Diagnosis “TB LAMP”:
Molecular diagnostic tests offer an important, rapid, and under-utilized molecular tool in TB diagnosis. These tests detect mycobacteria with high specificity by amplifying target nucleic acid sequences. WHO recommends that a molecular diagnostic test be performed on the first sputum sample of all suspected TB patients regardless of smear results.

TB LAMP is a manual molecular test to detect Mycobacterium Tuberculosis complex (MTBC), which is an attractive diagnostics platform, because it takes less than 1.5 hours to perform, requires minimal instrument, and generates a fluorescent result that can be detected with the naked eye. TB LAMP requires only minimal instrument in the form of a heating block.
Additionally, it has the potential for higher throughput as it can test up to 14 samples per test run (up to 70 samples per day). TB LAMP which is a simple, accurate, robust and affordable test, has been developed for use in high burden and resource limited settings.


Product Information:
TB LAMP uses LAMP technology to detect MTBC accurately at peripheral health centers, where smear microscopy is usually performed. TB LAMP provides better results than microscopy, detecting 15% more patients with pulmonary TB when used for all persons presenting with signs or symptoms of TB. If used as an add-on test after microscopy, the increase in TB cases detected among those with smear-negative results is more than 40%(*1).


WHO Policy Guidance TB LAMP for the diagnosis of pulmonary tuberculosis (2016):
WHO recommends that TB LAMP may be used as a replacement for microscopy for the diagnosis of pulmonary TB in adults with signs and symptoms of TB. TB LAMP may also be considered as a follow-on test to microscopy in adults with signs and symptoms of pulmonary TB, especially when further testing of sputum smear-negative specimens is necessary.
*Cost effectiveness of TB-LAMP is referred to the policy guidance from WHO.

Reference
“The use of loop-mediated isothermal amplification (TB-LAMP) for the diagnosis of pulmonary tuberculosis: policy guidance”, WHO, 2016
*1 Table 6, Table 7



Innovative Tool for Malaria Diagnosis “Malaria LAMP”:
Malaria LAMP is designed to address the need for a molecular test that achieves higher sensitivity and specificity than microscopy and rapid diagnostic tests (RDTs) requiring fewer infrastructure than PCR and can be adapted to field settings. Therefore, in addition to replacing microscopy in situations such as screening of returned travelers in nonendemic countries, the assay has potential as a reference standard in resource limited settings; and as a tool for surveillance and screening when a highly sensitive assay is needed.


Product Information:
Malaria LAMP is a comprehensive molecular solution introduced for the diagnosis of malaria. The test can differentiate between Plasmodium pan species, P. falciparum and P. vivax , and has a sensitivity of 84–94%, a specificity of >92% and a limit of detection of 1–2 parasites/µL (*2).

Malaria LAMP displays similar sensitivity to PCR (down to 1 parasite/µL of blood) and is an optimal alternative to PCR-based tests as it can be relatively easily deployed outside reference laboratories. Moreover, Malaria LAMP presents many operational advantages over PCR, including minimal equipment, shorter time-to-result (40 min), lower cost and, from a technical point of view, less complexity.

Reference
*2 Howes RE et al. Am J Trop Med Hyg 2016; 95(6 Suppl):15-34.

For technical information, please check Eiken GENOME SITE



Real-Time Turbidimeter and Isothermal Incubator with Visual Detection Unit

LA-500
(with CE marking)

Pamphlet

 LF-160
- with CE marking –


In vitro Diagnostic

Code No.

Product Name

Unit

Storage

LMC521 Loopamp MTBC Detection Kit 96 tests 2 – 30°C
LMC802 Loopamp PURE DNA Extraction Kit 90 tests 1 – 30°C
MVL310 Pipette-60 Set 384 tips 1 – 30°C
975000 Loopamp Malaria Pv Detection Kit 96 tests 2 – 30°C
977000 Loopamp Malaria Pan Detection Kit 96 tests 2 – 30°C
978000 Loopamp Malaria Pf Detection Kit 96 tests 2 – 30°C

Remarks:
HUMAN Gesellschaft für Biochemica und Diagnostica mbH is our global distributor for TB and Malaria LAMP (except Japan, China, Korea, Taiwan and Thailand).



Amplification kits and Fluorescence Detection Reagent (For Research Use only)

Code No.

Product Name

Unit

Storage

LMP207 Loopamp DNA Amplification Reagent D 96 tests 1 – 30°C
LMP247 Loopamp RNA/DNA Amplification Reagent D 96 tests 1 – 30°C


Detection kits (Japanese Package only)

For Foods Inspection

Code No.

Product Name

Unit

Storage

LMP601

Loopamp Salmonella Detection Kit

48 tests

-20°C

LMP621

Loopamp Verotoxin-producing Escherichia coli Detection Kit

48 tests

-20°C

LMP641

Loopamp Verotoxin Typing Kit

24 tests

-20°C

LMP631

Loopamp Escherichia coli O157 Detection Kit

48 tests

-20°C

LMP701

Loopamp Listeria monocytogenes Detection Kit

48 tests

-20°C

LMP721

Loopamp Campylobacter Detection Kit

48 tests

-20°C


For Environment Inspection

Code No.

Product Name

Unit

Storage

LMP661

Loopamp Legionella Detection Kit E

48 tests

-20°C

LMP741

Loopamp Cryptosporidium Detection Kit

48 tests

-20°C

LMP761

Loopamp Giardia Detection Kit

48 tests

-20°C

 

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