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Lateral flow immunoassay-based laboratory algorithm for rapid diagnosis of diphtheria
Vyacheslav G Melnikov1, Anja Berger2, Alexandra Dangel2
1National Conciliary Laboratory on Diphtheria, Bavarian Health and Food Safety Authority, Oberschleißheim, 85764, Germany.
Open Research Europe
|August 30, 2023
Summary
A new Lateral Flow Immunoassay (LFIA) offers rapid and accurate laboratory diagnosis for diphtheria. This method detects diphtheria toxin (DT) faster than traditional methods, improving global health outcomes.
Area of Science:
- Medical Microbiology
- Immunodiagnostics
- Infectious Diseases
Background:
- Diphtheria, a rare but life-threatening disease, is seeing an increase in cases due to migration and zoonotic factors.
- Current laboratory diagnosis of diphtheria is time-consuming, often requiring specialized central reference laboratories.
- A faster diagnostic method is needed to enable testing closer to patients and improve timely treatment.
Purpose of the Study:
- To develop and validate a Lateral Flow Immunoassay (LFIA) for the rapid detection of diphtheria toxin (DT).
- To establish a laboratory algorithm for diphtheria diagnosis using LFIA, aiming to reduce turnaround time.
- To assess the feasibility of performing diphtheria testing in laboratories with less specialized equipment.
Main Methods:
- A LFIA was designed using monoclonal antibodies targeting the receptor-binding subunit B of diphtheria toxin.
- The LFIA was validated using 322 corynebacterial cultures and 360 simulated diphtheria specimens from human pharyngeal samples.
- Simulated specimens were cultured on tellurite agar, and characteristic colonies were tested for DT using LFIA after 18-24 hours incubation.
Main Results:
- The LFIA demonstrated high diagnostic sensitivity (99.35%) and perfect specificity (100%) for DT detection on bacterial cultures.
- The assay correctly identified toxigenic strains in simulated pharyngeal samples and showed negative results for non-toxigenic strains.
- Under routine conditions, diphtheria could be detected within two working days, significantly faster than conventional methods.
Conclusions:
- The developed LFIA provides a simple, reliable, and rapid method for diphtheria diagnosis.
- This methodology has the potential to significantly speed up and enhance the accuracy of diphtheria detection globally.
- LFIA implementation can facilitate decentralized laboratory testing, improving accessibility and patient care.
