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Microbial-produced biologics are used as diagnostic reagents for target protein, antigen and antibody assay. Labeled VHHs/sdAbs/nano-antibodies or antibody fragments, as in vivo diagnostics, are being studies in clinical trial for target-positive tumor diagnosis, such HER2, PD-1, MMR, CD38, CD8, CD206. VHHs or antibody fragments, as an alternative of antibodies, can also be used as in vitro diagnosis for antigen testing. Besides, virus or bacterial recombinant antigens can be used in immunoassay kit for immunoglobulin M (IgM) antibodies and IgG test. For example, recombinant HBcAg and HBsAg produced in E.coli are involved in Anti-HBs Assay Kit; anti-HCV kit includes recombinant HCr43 protein, c100-3, and NS5-SOD produced in E.coli or yeast. Other commercial kits include anti-HEV, anti-HIV-1/HIV-2, anti-HTLV, anti-HCMV assay, and so on. Yaohai Bio-Pharma provides CRDMO solutions for VHHs/sdAbs/nano-antibodies, antibody fragments, and antigens, based on microbial fermentation systems, e.g., bacteria (Escherichia coli), yeast (Pichia pastoris, Saccharomyces cerevisiae, Hansenula polymorpha).

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