ONE STEP Malaria(p.f.) Test

Dénomination commerciale

ONE STEP Malaria(p.f.) Test

06936155804375

B-06936155804375

Numéro de référence/catalogue

ITP11002-TC40

GS1

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The One Step Malaria (P.f) Test is a rapid, immunochromatographic assay for the qualitative detection of the specific soluble protein, histidine-rich protein II (Pf HRP II), which is present in and released from infected red blood cells. The presence of Pf HRP can be detected within 15 minutes at the concentration of 200 parasites/µL or higher. The assay does not require additional instruments. This test is a rapid test as an aid in the diagnosis of malaria infection and relative symptoms; it only provides preliminary analysis results but not critical diagnosis criteria. The obtained results should be analyzed in connection with other clinical information, e.g. clinical symptoms, and alternate tests to make the final decision. The test is intended for healthcare professional use. Malaria infection caused by Plasmodium falciparum can be rapidly detected through the presence of Pf HRP II in human whole blood. The test is based on a colloidal gold enhanced immunochromatographic method. During the test, Pf HRP II in the specimen reacts with gold-conjugated anti-HRP II antibody, and the resulting immune complex is captured by the immobilized anti-HRP II antibody on the membrane, forming a visible colored test line. The control line indicates that the test has been performed properly, and the result is interpreted visually within 15–20 minutes.

URL des informations complémentaires

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Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0105090401PLASMODIUM (MALARIA) - RT & POC

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• CW011

  For in vitro diagnostic use only. Follow the instructions for use carefully.; Consult instructions for use
• CW010

  Read the instructions for use carefully before use.
• CW008

  Treat all specimens as potentially infectious.Wear gloves and protective clothing when handling specimens and dispose of biohazardous materials according to standard safety precautions.
• CW009

  Do not re-use the test card or any single-use accessories.
• CW007

  Do not use the test card if the foil pouch is damaged.