02276nas a2200265   4500000000100000008004100001653001300042653001200055653000800067100001300075700001300088700001500101700001500116700001100131700002100142700001400163700002400177700001600201700002200217245012000239300001200359490000800371520161700379022001401996       2014                            d10aSerology10aleprosy10aBSA1 aMoura RS1 aPenna GO1 aFujiwara T1 aPontes MAA1 aCruz R1 aSá Gonçalves H1 aPenna MLF1 aPaula Vaz Cardoso L1 aStefani MMA1 aBührer-Sékula S00aEvaluation of a rapid serological test for leprosy classification using human serum albumin as the antigen carrier.  a35 - 410 v4123 a<p>The presence of anti-BSA antibodies may interfere in serological tests, as ELISA or immunochromatographic assays. BSA is frequently used as a blocking agent or as "inert" carrier of antigens, such as the NT-P-BSA, the semi-synthetic trisaccharide analogue of the PGL-I (phenolic glycolipid-I) antigen from the cell wall of the Mycobacterium leprae. PGL-I was prepared and linked to human serum albumin based in the hypothesis that replacing BSA by a human protein carrier would enhance the performance of leprosy serological tests. A total of 1162 serum samples were tested by ELISA and by the ML Flow rapid test using NT-P-BSA or NT-P-HSA antigens. When grouping leprosy patients as paucibacillary (PB) or multibacillary (MB) according to the Ridley &amp; Jopling classification, ML Flow BSA and ML Flow HSA tests correctly allocated 70.9% and 68.6% of patients in the PB group, and 87% and 81% of patients in the MB group, respectively. Concordant results were found in 82.0% (953/1162) (kappa value=0.637; sd=0.023) of samples between ML Flow tests and 85.7% (996/1162) (kappa value=0.703; sd=0.021) between ELISA tests. ML Flow results were statistically similar and the same was true for ELISA tests using HSA or BSA. However, we noticed a tendency to decreased capacity to detect MB patients and an increased positivity among PB patients, HHC, TB patients and healthy controls by the HSA carrier in both ML flow and ELISA. The PGL-I serology performed by the ML Flow test with BSA or HSA as antigen carriers can be a useful, friendly auxiliary tool to identify patients with higher bacterial load.</p>
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