Name: POCT Malaria Ag (Pf/Pv) Card
Brand: Reckon Diagnostics
SKU: POCT-MAL.102N

Cassette: no photograph of this pack is published yet

Drawing, not a photograph. This pack has not been photographed yet; the stock codes and pack sizes below are the specification.

CARD, WITH LANCET & SWAB format. supplied as 50 tests.

Pack size

50 Test with lancet & swabPOCT-MAL.102N

Stock code POCT-MAL.102N

ASK ABOUT THIS PRODUCT →

Made and batch-released in Vadodara
ISO 13485:2016 quality system
Datasheet published: see every stock code below

Product details.

The POCT Malaria Ag (Pf/Pv) Card is a rapid, qualitative chromatographic immunoassay for P. falciparum specific histidine-rich protein II (HRP-II) and P. vivax specific pLDH in human whole blood, packed for point-of-care use with a lancet and alcohol pad for each test. Separate Pf and Pv lines tell falciparum, vivax and mixed infections apart. Manufactured at Reckon’s Vadodara facility under ISO 13485:2016 quality management, and released against reference standards before dispatch.

The specifications and steps on this page are from the datasheet, last updated 10-2020. The datasheet governs: read it before use, or ask us.

Method: Chromatographic immunoassay
Sample: Whole blood
Sample volume: 5 µl
Read at: 20 minutes
Sensitivity: 100%
Storage: 2 to 40 °C

Full specification15 items

Category: Rapid diagnostics
Format: CARD, WITH LANCET & SWAB
Pack: 50 tests
Datasheet: Published
Method: Chromatographic immunoassay, colloidal gold
Detects: P. falciparum HRP-II (line Pf) and P. vivax pLDH (line Pv)
Sample: Whole blood, from the fingertip or venous with anticoagulant; heparin, EDTA and citrate do not affect results
Sample volume: 5 µl
Buffer: 3 drops (90 µl), then 1 more after 5 minutes
Read at: 20 minutes; do not read after 30 minutes
Limitation: A primary screening test; a negative does not rule out P. ovale or P. malariae; in falciparum carriers (gametocytes) the Pf line may be absent
Contents: 50 cards, assay buffer, 50 sample droppers (5 µl), 50 sterile lancets and 50 alcohol pads
Storage: 2 to 40 °C in the sealed pouch; shelf life 24 months from manufacture
Stock codes: POCT-MAL.102N
Made in: Vadodara, Gujarat, India

Performance3 figures

Sensitivity: 100%: 32 of 32 P. falciparum and 45 of 45 P. vivax samples (in-house study of 292 samples against microscopy)
Specificity: 100%: 215 of 215 malaria-negative samples
Detection limit: Compared with microscopy at more than 200 parasites per µl, following the WHO (FIND) testing assessment protocol

Procedure at a glance5 steps

Clean the fingertip with the alcohol pad, let it dry, and prick it with the single-use lancet.
Collect 5 µl of blood with the capillary dropper and load it into sample well S.
Add exactly 3 drops (90 µl) of assay buffer to well A, letting each drop soak in.
After 5 minutes, add one more drop of buffer to clear the background.
Read at 20 minutes: C alone is negative; C and Pf is P. falciparum; C and Pv is P. vivax; C, Pf and Pv is a mixed infection. No C line means the test is invalid.