The World Health Organization (WHO) was notified in 2024 that patients with confirmed malaria infection had faintly positive test lines from a variety of malaria rapid diagnostic tests (RDT). Products that identify both Plasmodium falciparum and Plasmodium vivax, as well as products that detect both Plasmodium falciparum and pan species, have been the subject of incidents in a number of countries.

Patients with low parasitemia (200 parasites/µl) were the ones who primarily showed the pale test lines. However, weak test lines were also produced by some patients with higher parasitemia levels. According to more recent studies, faint test lines have caused misdiagnosis and, as a result, delayed the start of necessary therapy. The manufacturers have conducted their investigations in accordance with globally accepted standards.

Risk description:

Despite products meeting WHO requirements for good performance, rapid diagnostic tests for malaria may produce false-negative findings. False negative test results are more likely to be reported when test lines are faint, which can cause misdiagnosis, treatment delays, and delays in diagnosis. When a misdiagnosis happens, there is a greater chance of injury, including death or a major decline in health.

Steps that users and medical professionals should take:

1. Pay close attention to the product’s usage instructions, especially:

Interpret any test line as positive, regardless of how faint it is.
Fill the specimen transfer device entirely, then dispense the blood.

2. Adhere to the test kit’s storage requirements.

3. Encourage patients to return for a re-evaluation or re-testing if their symptoms worsen or their condition does not improve if the RDT results are negative and no other diagnosis is discovered.

4. Through their local authorized representative, notify the manufacturer of any unexpected test findings.

National malaria control programs will adopt the following actions:

1. Verify that RDT storage and transportation conditions adhere to the manufacturer’s recommendations for use throughout the duration of the product’s life.

2. Ensure that RDT users receive current training and supervision, and that they are made particularly aware of the issues mentioned in this information notice.

3. Verify that end users’ visual acuity is normal or corrected.

4. Actively contact testing locations to get their input on any odd patterns.

5. Assist manufacturers in looking at odd test results.

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