Improved sensitivity of the urine CAA lateral-flow assay for diagnosing active Schistosoma infections by using larger sample volumes

Particle and Fibre Toxicology

Govert J van Dam⁴  Pauline NM Mwinzi¹  Diana MS Karanja¹  Elizabeth A Ochola¹  Thomas M Kariuki²  Claudia J de Dood³  Ruth K Nyakundi²  Paul LAM Corstjens³ 

[1] Center for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya;Institute of Primate Research, National Museums of Kenya, Nairobi, Kenya;Department of Molecular Cell Biology, Leiden University Medical Center, Einthovenweg 20, Leiden, 2300 RC, the Netherlands;Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands

关键词: Upconverting phosphor (UCP);    Lateral flow (LF);    Diagnostic test;    Elimination;    Transmission interruption;    Active infection;    Circulating anodic antigen (CAA);    Schistosomiasis;   

Others  :  1181791
DOI  :  10.1186/s13071-015-0857-7

 received in 2015-03-20, accepted in 2015-04-13,  发布年份 2015

【 摘 要 】

Background

Accurate determination of Schistosoma infection rates in low endemic regions to examine progress towards interruption of transmission and elimination requires highly sensitive diagnostic tools. An existing lateral flow (LF) based test demonstrating ongoing infections through detection of worm circulating anodic antigen (CAA), was improved for sensitivity through implementation of a protocol allowing increased sample input. Urine is the preferred sample as collection is non-invasive and sample volume is generally not a restriction.

Methods

Centrifugal filtration devices provided a method to concentrate supernatant of urine samples extracted with trichloroacetic acid (TCA). For field trials a practical sample volume of 2 mL urine allowed detection of CAA down to 0.3 pg/mL. The method was evaluated on a set of urine samples (n = 113) from an S. mansoni endemic region (Kisumu, Kenya) and compared to stool microscopy (Kato Katz, KK). In this analysis true positivity was defined as a sample with either a positive KK or UCAA test.

Results

Implementation of the concentration method increased clinical sensitivity (Sn) from 44 to 98% when moving from the standard 10 μL (UCAA10 assay) to 2000 μL (UCAA2000 assay) urine sample input. Sn for KK varied between 23 and 35% for a duplicate KK (single stool, two slides) to 52% for a six-fold KK (three consecutive day stools, two slides). The UCAA2000 assay indicated 47 positive samples with CAA concentration above 0.3 pg/mL. The six-fold KK detected 25 egg positives; 1 sample with 2 eggs detected in the 6-fold KK was not identified with the UCAA2000 assay.

Conclusions

Larger sample input increased Sn of the UCAA assay to a level indicating ‘true’ infection. Only a single 2 mL urine sample is needed, but analysing larger sample volumes could still increase test accuracy. The UCAA2000 test is an appropriate candidate for accurate identification of all infected individuals in low-endemic regions. Assay materials do not require refrigeration and collected urine samples may be stored and transported to central test laboratories without the need to be frozen.

【 授权许可】

   
2015 Corstjens et al.; licensee BioMed Central.

【 图 表 】

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