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ISO/PWI TS 24883 Lateral flow immunoassay for rapid diagnostic testing — General guideline for test performance

By December 1, 2023No Comments

Scope

This document provides the general principles and guideline for the rapid diagnostic testing (RDT) of LFIA used for the In vitro diagnostics as follows:

— Design and development of LFIA

— General guideline for test performance of LFIA

— Recommendations for the use of LFIA

This document is specific to the RDT of LFIA, which employ the gold nanoparticle as the conjugate and read the signal either with naked eye or through reader devices. This document does not apply to other types of LFIA such as automatic devices and microfluidic chips.

This document should be expected to be helpful to increase efficiency and reduce trials and errors when manufacturing LFIA RDT products to the industries and/or manufacturers.

Purpose

Rapid Diagnostic Testing (RDTs), which is based on Lateral Flow Immunoassay (LFIA), serves as a swift method to ascertain the existence or absence of specific target analytes (such as antigens, antibodies, or other biomarkers) within a patient’s sample. This technique finds extensive employment in promptly testing various diseases and conditions, encompassing infections, within medical facilities, point-of-care setups, and even home environments. RDTs yield rapid outcomes, often attainable within a matter of minutes, thereby facilitating timely diagnoses and enabling immediate initiation of requisite treatments, especially in exigent scenarios necessitating swift decisions.

Despite the prolific production, import, and export of numerous RDT products on a global scale, a uniform and specific guideline is yet to be universally established. As a result, these products are evaluated and validated by comparing them to approved counterparts to demonstrate equivalence or superiority. Additionally, a consistent worldwide guideline for diagnostic reagents remains elusive, raising inquiries about their precision and sensitivity. Consequently, the establishment of a global RDT guideline emerges as a crucial imperative to assess test efficacy and ensure uncompromised quality. During outbreaks or pandemics like the COVID-19 crisis, the prompt availability and deployment of accurate diagnostic tests emerge as paramount. The existence of internationally acknowledged guidelines expedites the rapid creation and validation of novel RDTs, thereby enhancing worldwide preparedness and response capabilities and enabling the timely identification and containment of infectious ailments.

Within the realm of global health, the capability to compare test outcomes across diverse regions and countries takes on indispensable significance. Adherence to international guidelines empowers varied manufacturers to generate assays that are not only compatible but also comparable. This, in turn, facilitates healthcare providers in exchanging data, collaborating on research endeavours, and implementing effective public health strategies that transcend national boundaries. By championing standardized manufacturing protocols, international guidelines contribute to the realization of economies of scale and enhanced cost efficiency. This, in effect, can drive down costs, rendering RDTs more affordable and accessible to a broader populace, thereby ameliorating overall healthcare outcomes.

In summary, international guideline pertaining to lateral flow immunoassays and RDTs occupy a pivotal role in upholding precision, dependability, comparability, and cost-effectiveness. They stand as indispensable constituents of global health endeavours and emergency responses, ultimately culminating in the enhancement of worldwide public health outcomes.

Comment by: 16 January 2024

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