# Rapid Point-of-Care Assay for Diagnosis of Neurocysticercosis in Seizure Patients

> **NIH NIH R43** · KEPHERA DIAGNOSTICS, LLC · 2021 · $299,998

## Abstract

Project Summary
Epilepsy, a disorder of the brain manifested by seizures, is the fourth most prevalent neurological disease,
affecting over 50 million people worldwide, or about 1 out of 150 individuals on average. The frequency of
epilepsy is distributed unevenly, however, with the vast majority of cases occurring in less developed regions
of the world. The explanation for this distribution is most likely that one third of all epilepsy cases are due to
Neurocysticercosis, known to be the most common parasitic infection of the nervous system.
Neurocysticercosis is caused by the presence of larval cysts of Taenia solium, the pork tapeworm, in the brain,
which can cause seizures and illness ranging from mild to fatal depending on their location, number and
viability. In contrast to idiopathic epilepsy, a complex disease which can be difficult to treat and resistant to
cure, Neurocysticercosis can be treated and in many cases cured with inexpensive and available anti-
helminthic drugs. Distinguishing whether the cause of seizures is idiopathic epilepsy or Neurocysticercosis is
thus a critical part of the diagnostic workup and essential to determine the appropriate course of treatment for
patients. The established procedures for diagnosing epilepsy comprise electroencephalography and imaging
via MRI, but these sophisiticated tools are of limited availability in the less developed world where
Neurocysticercosis is most frequent. On the other hand, Neurocysticercosis can be diagnosed with a
serological test that detects antibodies to T. solium cysts. The gold standard serological test, the Enzyme
Immunotransfer Blot (EITB) developed at CDC, is a laboratory-based test, however, that is not widely available
and requires significant training to carry out. Thus there is a critical need for a rapid, commercially available
point-of-care test for Neurocysticercosis that can be used to test patients with seizures, in order to identify
those with the parasitic infection so that they can be treated effectively. Development of such a test has been
identified as an urgent priority by the World Health Organization.
In the Phase I project, we will utilize recombinant and synthetic T. solium antigens corresponding to those used
in the EITB to develop a point-of-care serological test for Neurocysticercosis that will meet the criteria in the
World Health Organization’s Target Product Profile. These antigens have shown high sensitivity and specificity
in prior studies, and will be combined to further increase sensitivity for detection of single viable cysts, the most
challenging case. The point-of-care Neurocysticercosis test will be evaluated for sensitivity on a well-
characterized panel of sera from Neurocysticercosis patients confirmed by EITB or clinical diagnosis, and for
specificity on healthy controls and other disease state sera. Test results will be read using a field-friendly,
ultraportable, low-cost reader that will provide objective interpretation and enabl...

## Key facts

- **NIH application ID:** 10084274
- **Project number:** 5R43AI149903-02
- **Recipient organization:** KEPHERA DIAGNOSTICS, LLC
- **Principal Investigator:** Andrew E. Levin
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $299,998
- **Award type:** 5
- **Project period:** 2020-01-10 → 2022-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10084274

## Citation

> US National Institutes of Health, RePORTER application 10084274, Rapid Point-of-Care Assay for Diagnosis of Neurocysticercosis in Seizure Patients (5R43AI149903-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10084274. Licensed CC0.

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