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BACKGROUND: Dried blood collection devices might be beneficial for diagnosing infectious diseases in areas far from the medical facilities and in lockdown situations. There are several reports on the efficacy of such applications for qualitative tests. Here we demonstrated the feasibility of a novel Ser-Col blood collection device as a standardized approach for qualitative and quantitative detection of infectious markers and several over immunochemical tests. METHODS: In the current study, we included 395 adult participants, 191 men and 204 women, with a median age of 41 years, as well as 75 children with a median age of 3 years. Serological status was determined by testing serum samples for three groups of infection diseases: hepatitis A and C, SARS-CoV-2, and herpes family viruses, as well as for thyroid peroxidase (TPO), prolactin, vitamin B12, and folate. Blood collected on the Ser-Col device (Labonovum) was eluted using an automated system (SCAUT Ser-Col automation, Blok System Supply) and manually. Ser-Col results were compared with serum sampled via standard venipuncture considered as the reference. RESULTS: High correlation coefficients (r = 0.95-0.99) were observed between serum samples collected with Ser-Col and via standard venipuncture for the following tests: anti-HCV, anti-SARS-CoV-2 IgG, anti-HSV-2 IgG, and anti-CMV IgM. Correlation coefficients between Ser-Col and standard venipuncture serum for anti-HSV-1 IgG, anti-CMV IgG, and anti-EBV tests were relatively low (r = 0.73-0.77). Correlation coefficients for anti-TPO, prolactin, vitamin B12, and folate were also characterized with high values (r = 0.97-0.99). CONCLUSIONS: High accuracy and quantitative correlation were demonstrated between Ser-Col and samples collected by standard venipuncture. Hence, the Ser-Col blood collection device should be considered as a promising alternative for blood collection, storage, and transportation in both adult and pediatric populations.
RESUMO
Blood spotted onto filter paper can be easily collected outside healthcare facilities and shipped to a central laboratory for serological testing. However, dried blood testing generally requires manual processing for pre-analytical steps. In this study, we used a standardized blood collection device combined with an automated elution system to test illegal gold miners living in French Guiana for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and syphilis. We included 378 participants, 102 females and 266 males, in three illegal gold mining resting sites. Blood collected on the Ser-Col device (Labonovum) was eluted using an automated system (SCAUT Ser-Col automation, Blok System Supply) and an automated analyzer (Alinity i, Abbott). Ser-Col results were compared to both plasma results, considered the gold standard, and to Dried blood Spot (DBS) results, considered the reference sampling method using dried blood. In plasma samples, two participants (0.5%) tested positive for HIV, six (1.5%) tested positive for hepatitis B surface antigen (HBsAg), eight were weakly positive for anti-HCV antibodies but negative for HCV RNA, and 47 tested positive for treponemal antibodies (12.4%), including 20 females (19.6%) and 27 males (9.8%, p= 0.010179). We observed a full concordance of Ser-Col and DBS results for HIV diagnosis compared to plasma results. Ser-Col and DBS samples tested positive in five HBsAg carriers and negative for one participant with a low HBsAg level in plasma (0.5 IU/mL). All participants tested negative for HCV in Ser-Col and DBS samples, including the eight participants who tested low positive for HCV antibodies and HCV RNA negative in plasma. Among syphilis seropositive participants, 41 (87.2%) and 40 (85.1%) tested positive for treponemal antibodies in Ser-Col and DBS samples, respectively. The Ser-Col method allows automated dried blood testing of HIV, HBV, HCV and syphilis with performances comparable to DBS. Automated approaches to test capillary blood transported on dried blood devices may facilitate large-scale surveys and improve testing of populations living in remote areas.