Carbon black as a colorimetric label for an immunochromatographic test strip for severe fever with thrombocytopenia syndrome virus detection.

ABSTRACT

To combat the ongoing threat posed by severe fever with thrombocytopenia syndrome virus (SFTSV), especially in underserved areas, there is an urgent need for an affordable and reliable point-of-care diagnostic tool. This study presents a carbon black-based immunochromatographic test strip (CB-ICTS) for the detection of SFTSV, which is both quick and easy to operate. The study optimized the specific steps for carbon black-labeled antibodies, as well as the amount of carbon black and anti-SFTSV antibody used. Under optimal experimental conditions, the linear range and limit of detection of the CB-ICTS were evaluated using different concentrations of SFTSV standard samples. The detection range of the CB-ICTS for SFTSV was found to be 0.1-1000 ng mL-1, with a limit of detection of 100 pg mL-1. The precision and accuracy of the CB-ICTS were assessed by examining spiked healthy human serum samples, which displayed recoveries ranging from 91.58 to 105.4% with a coefficient of variation of less than 11%. This work evaluated the specificity of the CB-ICTS using various biomarkers (CA125, AFP, CA199, CEA, and HCG) and demonstrated that the CB-ICTS is highly specific for detecting SFTSV, suggesting its potential for the early diagnosis of SFTSV. In addition, the study evaluated the CB-ICTS in serum samples from patients with SFTSV, and the results were highly consistent with those detected by the polymerase chain reaction (PCR) method. Overall, this study demonstrates the feasibility and effectiveness of using the CB-ICTS as a reliable point-of-care diagnostic tool for the early detection of SFTSV.