Diagnosis of Schistosoma haematobium infection: evaluation of ELISA using keyhole limpet haemocyanin or soluble egg antigen in comparison with detection of eggs or haematuria.

Keyhole limpet haemocyanin (KLH) was compared with Schistosoma haematobium soluble egg antigen (SEA) in the enzyme-linked immunosorbent assay (ELISA) for detection of S. haematobium infection, using 187 human sera collected from the S. haematobium endemic area of Pemba Island, Tanzania, and 30 normal sera from blood donors in Europe. There was a clear separation in terms of immunoglobulin (Ig) G and IgM titres between parasitologically positive patients and the blood donors, but titres of many parasitologically negative individuals in the endemic area were significantly high in comparison with the normal controls. Using as cut-off point the mean optical density +2 SD of sera from the blood donors to define ELISA positivity, and comparing the results with urine egg counts, the sensitivity of IgG-ELISA using KLH or SEA was high (91.11% and 95.56%, respectively) but the specificity was poor (43.30% and 31.90%, respectively. Similar results were obtained with IgM. When the 'gold standard' of haematuria and/or egg positivity as indicative of infection was used, the sensitivity of the ELISAs was similar but the specificity was increased to 59.25% and 44.44%, respectively. These results suggest that the patients with haematuria were probably infected with S. haematobium, which further supported the diagnostic value of haematuria detection for S. haematobium infection in endemic areas, and KLH was found to have a potential use in immunodiagnosis of S. haematobium infection in endemic areas. With both KLH and SEA antigens, the trend of reactivity in ELISA provided a correlate of the egg output (parasite burden) of infected patients.