PGL-I QURapid (Quantitative Up-Converting Rapid Test)

A lateral flow test for anti-PGL-I IgM, developed at Leiden University Medical Center, that uses upconverting reporter particles and is read by a portable, battery-operated reader. It gives a numerical result rather than a visual positive or negative, so antibody levels can be compared between sites and over time, as serosurveys require. The strip comes in a standard plastic cassette or a plant-based biodegradable cassette made by Okos Diagnostics. Earlier versions of the same single-marker test were reported on strips from 2017. The cassette format was first published in a serosurvey of 1,857 children in Bihar, India (Pierneef et al., 2023), and later serosurveys included the Comoros and Madagascar.

Technology

Serology (Antibody) · Quantitative lateral flow

What it measures

Anti-PGL-I IgM, reader-quantified

Developer

Leiden University Medical Center (LUMC), Leiden, the Netherlands

Specimen

Capillary blood

Development status

LDT with clinical validation

Regulatory status

None / RUO

Intended use

Quantitative seroprevalence measurement for transmission surveillance, adjunct diagnosis of multibacillary leprosy and monitoring of treatment in multibacillary leprosy

Main limitation

Limited by the analyte, as are all anti-PGL-I assays.

Availability

Available from Leiden University Medical Center (LUMC). Produced at MaximBio (Rockville, MD, USA) in collaboration with LUMC.

Linked publications

8

Manufacturers and partners

MaximBio (Rockville, MD, USA), Okos Diagnostics (Leiden, the Netherlands)

TPP-1, confirming leprosy

61.5 of 100, partial alignment

TPP-2, infection in contacts

67.0 of 100, moderate alignment

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