Medical Devices & Diagnostics · LP-213
Malaria rapid diagnostic test Diagnostic test
Device / diagnostic development record. Review the proposed presentation and the professional reference information below.
Development record
- Portfolio reference
- LP-213Medical Devices & Diagnostics
- Product type
- Malaria rapid diagnostic testDiagnostic test
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Product-type reference
Record identity and reference background.
- Portfolio reference
- LP-213
- Product type
- Malaria rapid diagnostic test
- Device presentation
- Diagnostic test
- Configuration / specification
- Pf/Pan cassette
- Proposed pack
- Single-use pouch; carton 25
- Portfolio category
- Medical Devices & Diagnostics
About Malaria rapid diagnostic test
A malaria rapid diagnostic test is an in vitro assay that detects specified parasite antigens in an authorized blood specimen. A Pf/Pan description suggests different malaria targets but does not identify the actual antigen chemistry or species-detection performance. The device is not a medicine and does not measure treatment response in the same way as all other diagnostic methods. Its intended use requires exact assay documentation.
How to read this profile
Scientific information relates to the device or diagnostic type. It is not approved Luang Pharma labelling, a clinical recommendation, or evidence of equivalence to a referenced product. Multiple strengths or presentations represent separate proposed variants and must not be treated as interchangeable.
02 · Professional background
Scientific & clinical reference
Read the clinical context, selected safety considerations and presentation-specific information below.
Intended-use context
Malaria diagnosis should follow local epidemiology and clinical guidance, with microscopy or other assessment where appropriate. Test performance can be affected by low parasite density, target-antigen variation or gene deletions relevant to the assay. A negative result does not justify ignoring severe illness. Procurement should consider the specific setting and validated test performance; a generic Pf/Pan label is not proof of WHO prequalification or suitability for every malaria-endemic region.
Important safety considerations
False-negative and false-positive results can lead to delayed or unnecessary treatment. Some antigens can persist after infection, complicating interpretation. Sampling errors, heat or humidity damage and incorrect read timing can also affect results. Blood collection introduces sharps and infection risks. Severe symptoms require urgent medical assessment regardless of a rapid-test result, and laboratory or clinical follow-up may be needed under local guidance.
These are selected considerations, not a complete list. Use the current instructions or approved label for the exact authorised product and seek appropriate professional advice.
Presentation, handling and storage
The source specifies a cassette without identifying target antigens, specimen volume or read window. Confirm exact assay identity, targets, species coverage, performance at relevant parasite densities, limitations and local authorization. No numerical diagnostic claim is asserted.
Maintain the unopened kit within its validated transport and storage conditions and protect it from humidity. Use the supplied compatible buffer and sampling components exactly as instructed. Observe expiry and read timing, and retain lot details for quality investigation.
Final composition, instructions, shelf life and storage conditions are not established by this portfolio entry. They must come from the controlled documentation for the specific product.
Points for professional review
Confirm assay identity, epidemiological suitability, intended setting, performance evidence and any verified procurement status. Provide the authorized instructions, training and a pathway for discordant results.
03 · Product enquiry
Documentation & regulatory status
Evidence status
What is established — and what remains open
This record has received an editorial evidence-layer review. The review separates catalogue facts from unresolved product-specific fields and external context; it is not medical, regulatory or market-authorisation approval.
Layer 01
Controlled catalogue facts
- Device / diagnostic type
- Malaria rapid diagnostic test
- Presentation
- Diagnostic test
- Catalogue configuration
- Pf/Pan cassette
- Catalogue pack
- Single-use pouch; carton 25
- Portfolio category
- Medical Devices & Diagnostics
Layer 02
Unresolved product-specific fields
- P024 — “Pf/Pan cassette” does not identify the exact malaria antigen targets, specimen requirements, species coverage, read time, invalid-result criteria, operating temperature range or diagnostic performance.
- WHO guidance shows that malaria RDT products vary materially by target, format, performance and stability. No WHO prequalification or performance claim is inferred for LP-213.
- Approved indication, patient eligibility and dosing or test interpretation are not established by this portfolio record.
- Registration/authorization, manufacturing or site status, supply availability, storage conditions and shelf life remain product- and market-specific evidence items.
Layer 03
Attributed external context
- WHO: malaria rapid diagnostic testsinternational public-health diagnostic guidance
- WHO: malaria RDT selection and procurement considerationsinternational public-health diagnostic guidance
These references provide scientific or regulatory context only. They are not Luang Pharma product labelling, registration, manufacturing evidence, equivalence evidence or confirmation of supply.
Layer 04
Documents required to close the record
- Exact malaria RDT model/IFU including antigen targets, species claims, specimen and transfer device, read window, invalid criteria, performance data, stability and destination-market authorization/prequalification evidence as applicable.
- Destination-market device/IVD classification and authorization/conformity evidence for the exact model; generic FDA/WHO references are not evidence for the Luang record.
- Model-specific quality/performance verification and current packaging/label artwork before any public certification, accuracy, sterility or compatibility claim.
- Manufacturing/supply-status evidence before any claim that the device is produced, stocked, registered or available through Luang Pharma.
For LP-213, identify the destination country, intended professional use, proposed presentation and the role of your organisation. The appropriate supply route and available documentation must be confirmed for that case.
- Confirm the legal entity, manufacturing site and authorised scope for the proposed supply chain.
- Confirm device classification, intended use, conformity evidence and local import requirements.
- Request relevant product information, specifications and supporting evidence through the company contact.
- Confirm storage, transport, traceability, complaints and safety-reporting responsibilities before any agreement.
The public catalogue extends beyond the initial planned facility modules. A listing does not mean that the dosage form is installed, qualified or licensed at Boten.
04 · External sources
Sources and further reading
External sources are provided for reference. Their authors do not endorse Luang Pharma, and another product’s authorisation does not transfer to this portfolio record. Source availability and wording can change.
Professional enquiries
Request product-specific evidence for LP-213.
State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.