Malaria Antigen Card Test (Pf/PAN)

Intended Use: Malaria Pf/PAN Antigen Detection Card Test is intended to be used for the detection of malarial antigens: HRP2 for P. falciparum and pLDH for PAN malaria. 

Pack size: 50 Tests 

Shelf life: 24 months 

Storage: 4° to 30° C 

This is a rapid antigen card test designed for use with whole blood and visual interpretation of results. For general context on malaria rapid diagnostic tests (RDTs), see WHO’s overview of how malaria RDTs work: WHO – How malaria RDTs work.

Product overview

Malaria Pf (HRP2) / PAN (pLDH) Antigen Card Test contains a membrane strip with two test lines and one control line. One test line is specific to HRP2 (for P. falciparum) and the other (PAN) is specific to pan Plasmodium lactate dehydrogenase (pLDH). The control line (C) acts as an internal procedural control. 

Test Specifications

• Specimen: human whole blood (finger prick or venipuncture) 
• Sample volume: 5 µL into sample well (S) 
• Buffer: 2 drops into buffer well (B) 
• Read time: interpret at 15–20 minutes; do not read after 30 minutes 
• Targets detected: P. falciparum HRP2 and PAN pLDH 
• Relative performance (IFU): sensitivity 98.4%, specificity 97.5% 

Principle of the test

After adding whole blood and assay buffer to the respective wells, the blood lyses and migrates along the membrane to react with conjugate pad antibodies. If HRP2 and/or PAN pLDH antigens are present, coloured bands appear in the corresponding test regions along with the control line.

Materials provided

• Malaria Pf/PAN antigen test device (individually foil-pouched) with desiccant and plastic loop
• Assay buffer
• Product insert 

Specimen collection and storage

• Perform the test with freshly collected whole blood from fingertip or by venipuncture using an anticoagulant tube. 
• Anticoagulants include heparin, citrate, or EDTA. 
• For short-term storage, keep specimens at 2–8°C. 

Test procedure (summary)

1. Remove the device from the pouch and mark patient ID on the device. Perform the test immediately after removing from the foil pouch. 
2. Clean fingertip with an alcohol swab (not provided) and dry completely; prick fingertip with a single-use lancet. 
3. Use the loop provided to add 5 µL whole blood into the sample well (S). 
4. Add 2 drops of assay buffer into the buffer well (B). 
5. Interpret results after 15–20 minutes. Do not read after 30 minutes. 

Interpretation of results

• Negative: only one pink-purple band appears in the control window C. 
• Positive (A) – P. falciparum or mixed infection: control band plus bands at Pf and PAN. 
• Positive (B) – other species (non-falciparum): control band plus PAN band only. 
• Positive (C) – P. falciparum: control band plus Pf band only. 
• Invalid: if the control line C does not appear, repeat the test following the exact procedure. 

Quality control

A coloured line in the control line region (C) is an internal procedural control confirming sufficient specimen volume, adequate membrane wicking, and correct technique. Control standards are not supplied; however, testing positive and negative controls is recommended as good laboratory practice to confirm procedure and verify performance. 

Limitations

This test is designed for primary screening. It can provide a fast and easy result but does not completely exclude the possibility of false positive or false negative results; results obtained should be correlated clinically. 

Storage and expiration

• Store the kit between 4° and 30°C. 
• Expiration date is as mentioned on the label. 
•  Shelf life is 24 months.

Performance characteristics 

• Relative sensitivity: 98.4%
• Relative specificity: 97.5% 

Frequently Asked Questions

What does the Malaria antigen card test detect?

Malarial antigens: HRP2 for P. falciparum and pLDH for PAN malaria. 

What sample is required?

Human whole blood (finger prick or venipuncture using anticoagulant tube). 

How long does it take to read results?

Interpret after 15–20 minutes; do not read after 30 minutes. 

What does an invalid result mean?

If the control line C does not appear, the test is invalid and should be repeated.