loop and desiccant. Check the color of the desiccant. It should be blue. If it has turned colorless or pink, discard the device and use another device. Once

 

Reagents and Material Supplied

Paramax-3 kit contains:

A. Individual pouches, each containing:

1. Test Device Membrane assembly predispensed

with monoclonal anti-HRP-2 antibody-colloidal

gold conjugate, monoclonal anti-P.vivax specific pLDH antibody-colloidal gold conjugate,

monoclonal anti-pan specific pLDH antibodycolloidal gold conjugate, rabbit globulin colloidal

gold conjugate, monoclonal anti-Pf. HRP-2 antibody, monoclonal anti-P. vivax specific pLDH

antibody, monoclonal anti-pan specific pLDH

antibody and anti-rabbit antibody at the respective regions.

2. Desiccant pouch

3. 5 µL sample loop.

B. Clearing buffer in a dropper bottle

C. Package insert.

Optional Material Required

Calibrated micropipettes capable of delivering

5 µL sample accurately.

Storage and Stability

The test kit may be stored between 4–30°C till the duration

of the shelf-life as indicated on the pouch/carton. Do not

freeze.

Note

Read the instructions carefully before performing the test.

For in vitro diagnostic use only. Not for Medicinal Use.

Do not use beyond expiry date. Do not intermix reagents

from different lots. Handle all specimens as potentially

infectious. Follow standard biosafety guidelines for handling and disposal of potentially infective material.

Specimen Collection and Preparation

Fresh anticoagulated whole blood should be used as a test

sample and EDTA or Heparin or Oxalate can be used as

suitable anticoagulant. The specimen should be collected

in a clean glass or plastic container. If immediate testing

is not possible, then the specimen may be stored at

2 to 8°C for up to 72 hours before testing. Clotted or

contaminated blood samples should not be used for

performing the test. Fresh blood from finger prick/

puncture may also be used as a test specimen.

Test Procedure

1. Bring the Paramax-3 kit components to room temperature before testing.

2. Open the pouch and retrieve the device, sample

loop and desiccant. Check the color of the desiccant.

It should be blue. If it has turned colorless or pink,

discard the device and use another device. Once

opened, the device must be used immediately.

3. Tighten the vial cap of the clearing buffer provided

Serology/Immunology 649

with the kit in the clockwise direction to pierce the

dropper bottle nozzle.

4. Evenly mix the anticoagulated blood sample by

gentle swirling. Dip the sample loop into the sample.

Ensuring that a loop full of blood is retrieved, blot the

blood so collected onto the sample pad in the sample

port ‘A’ (this delivers approximately 5 µL of the whole

blood specimen).