Paracheck Pf Device for Malaria

INTENDED USE
PARACHECK  – Pf® is an invitro, rapid, qualitative, two site sandwich immunoassay for the determination of P. falciparum specific
histidine rich protein – 2 (Pf. HRP-2) in whole blood for the diagnosis of falciparum malaria in individuals with signs and
symptoms consistent with malaria infection. The test is intended for healthcare professionals at clinical setup and point of care
sites. The test is also suitable for detection of P. falciparumMalaria in neonates and pregnant women.

REAGENTS AND MATERIALS SUPPLIED
kit contains :
A. 25 x  Individual pouches, each containing :
1. DEVICE: Membrane assembly predispensed with Agglutinating Sera for HRP-2 – colloidal gold conjugate, rabbit
globulin-colloidal gold conjugate, Agglutinating Sera for HRP-2 and Agglutinating Sera for rabbit globulin at the
respective regions.
2. Desiccant pouch.
3. PIPETTE : Disposable 5µl sample applicator.
B. 1 x BUF : Clearing buffer containing surfactant and preservative in a dropper bottle.
C. Package insert.
D. 25 x Alcohol swab.*
E. 25 x Sterile lancet.*