Malaria - Biosynex Ampliflash
Rapid molecular screening of malaria with LAMP (Loop-mediated Isothermal Amplification) isothermal amplification
BIOSYNEX AMPLIFLASH® MALARIA is an innovative, CE-IVD validated solution for the rapid detection of Plasmodium directly from a small amount of whole blood and can also be performed by fingerprick
The test uses a LAMP (Loop-mediated Isothermal Amplification) isothermal amplification technology to identify malaria infections in a combined and differentiated way, offering rapid, reliable and traceable results, BIOSYNEX AMPLIFLASH® MALARIA is the ideal choice for rapid and efficient screening in clinical, hospital and public health settings, where speed and reliability in the diagnosis of malaria are essential.
Molecular targets
- Pf (Plasmodium falciparum): specific detection of the gene associated with P. falciparum
- PAN: gene common to the 5 human pathogenic species (P. falciparum, P. vivax, P. ovale, P. malariae, P. knowlesi)
Result in just 30 minutes
- Use only 5 µL of whole blood with BIOSYNEX BLOOD LYSIS kit
Positive signal can emerge after 3 minutes of amplification
Connected solution for complete traceability of patient, result and operator
High performance
- Evaluated by the National Reference Center for Malaria (France)
- Complies with the recommendations of the Haute Autorité de Santé (HAS), with results available in less than 2 hours
Contents of the kits
BIOSYNEX BLOOD LYSIS:
- 4 tubes of lysis buffer
- 4 stabilization buffer tubes
BIOSYNEX AMPLIFLASH® MALARIA:
- 25single-use pouches containing everything needed for one test:
- test strip
- caps
- rehydration buffer
- 1 positive control tube
- 1 negative control tube
Click on the questions to get the answers
BIOSYNEX AMPLIFLASH® MALARIA is a rapid, sensitive and specific solution for the molecular screening of malaria. It allows the differentiated detection of Plasmodium falciparum and the other four human pathogenic species in a single analysis. The test is simple to perform, does not require complex instrumentation and provides results in less than 30 minutes. It is ideal for settings where timely diagnosis is essential: emergency rooms, infectious disease departments, travel medicine clinics, and endemic areas.
The test is based on an isothermal amplification technology LAMP (Loop-mediated Isothermal Amplification), which allows the detection of parasite DNA at a constant temperature, eliminating the need for thermal cycling as in PCR. The blood sample is first lysed using the BIOSYNEX BLOOD LYSIS kit. Subsequently, the genetic material is amplified and detected visually using a reactive strip included in each pouch. The result is visible within a few minutes from the start of amplification.
A very small amount of whole blood is sufficient: 5 µL. This makes the test particularly suitable for pediatric patients, emergency situations or in contexts with limited resources. The sample can also be taken using a finger prick.
The system is designed for maximum simplicity of operation. The necessary tools are:
- A simple thermal block (to maintain a constant temperature during amplification)
- The BIOSYNEX BLOOD LYSIS kit for sample preparation
- The disposable pouches of the BIOSYNEX AMPLIFLASH® MALARIA kit, which contain everything needed to perform the test, including the test strip and reagents
No thermal cyclers, centrifuges or automated platforms are required.
BIOSYNEX AMPLIFLASH® MALARIA can be used as a rapid screening test for all patients with clinical suspicion of malaria, especially in settings where conventional methods (blood smear, rapid antigen tests) may be insufficient or too slow. It can precede or support confirmatory tests such as PCR or microscopic examination, providing a first result in a few minutes and contributing to timely therapeutic decisions.
LAMP (Loop-mediated Isothermal Amplification) technology offers numerous advantages:
- Rapidity: amplification and reading of the result occur in a few minutes
- High sensitivity and specificity
- Absence of thermal cycles: it works at a constant temperature
- Ease of use in decentralized contexts or with low technological complexity
It is a technology particularly suitable for molecular tests in the field or in environments with limited diagnostic resources.
Yes, the National Reference Center for Malaria in France published a study entitled:
“Evaluation of two commercial kits and two laboratory-developed qPCR assays compared to LAMP for molecular diagnosis of malaria”
Azza Bouzayene, Rizwana Zaffaroullah, Justine Bailly, Liliane Ciceron, Véronique Sarrasin, Sandrine Cojean, Nicolas Argy, Sandrine Houzé, Valentin Joste.
The study compared two commercial qPCR kits, including BIOSYNEX AMPLIFLASH® MALARIA, with two internally developed tests and with the LAMP Alethia® Malaria test as a reference.
The results showed for BIOSYNEX AMPLIFLASH® MALARIA a sensitivity of 97.2% and a specificity of 100%, confirming the high reliability of the kit and its suitability for effective clinical use.
Conclusion of the study:
“Overall, these results accentuate the role molecular methods could play in the screening of malaria. This may represent a helpful tool for other laboratories looking to implement molecular diagnosis methods in their routine analysis, which could be essential for the detection and treatment of malaria carriers and even for the eradication of this disease”