Is Roche or Abbott the preferred luminescent reagent for imported infectious diseases? How about sensitivity and false positives

If there is concern about false positives, it is recommended to focus on the gray-zone sample confirmation process. For hepatitis virus chemiluminescence screening positive or gray-zone results, neutralization testing should be performed according to the laboratory SOP, or retesting should be done on a different platform/method; a positive result must not be reported based on a single value alone. For hepatitis B and C projects, serum panels or clinically confirmed samples can be used for verification, and weakly positive samples should be tested 10-20 times repeatedly to calculate the detection rate. When comparing two brands, suppliers can be asked to provide sensitivity and specificity data, but verification must be performed based on samples from this laboratory. It is recommended to conduct EP12 or a simple concordance study.

The key to reporting eight items to clinical practice before surgery is not simply the sensitivity value, but the repeatability and specificity of the low value gray area. It is suggested that Roche and Abbott should respectively provide intra/inter batch precision, minimum detection limit and gray area setting suggestions for hepatitis B surface antigen, hepatitis C antibody and other items, and use weak positive third-party quality control for 20 consecutive days. The pass rate of inter laboratory quality evaluation can be used as a reference, but the grouping of clinical inspection centers varies in different provinces, so it is best to look at feedback from users in the same group. Both brands have a large number of users in infectious disease projects, and the actual differences are more in laboratory operations and batch management.

Platform selection also depends on instruments and IT infrastructure. A daily volume of 150 samples is not large, but preoperative results must be timely, so consider STAT positions, clot detection, automated reruns, and bidirectional LIS. Roche and Abbott instruments have different operating habits, so it is recommended to have both vendors conduct separate demonstrations, running the same batch of clinical samples with their own original matched reagents and calibrators, with blinded sample numbering, focusing on concordance for weak positives and negatives. Then look at after-sales service: engineer response time, preventive maintenance frequency, and reagent delivery timeliness. Do not look only at the initial quote; sign a 3-year cost model.

Cost and delivery time: Imported original reagents and calibration products are purchased together, and the cost of single testing varies greatly among the eight different items before surgery, usually higher than domestic ones, ranging from tens to hundreds of yuan. The supplier needs to provide a quotation for 150 samples per day. The delivery time is generally 2-6 weeks, and some agents have regular inventory of key items such as HIV and HCV. Suggest packaging the eight items for annual usage and requesting separate quotations for consumables such as calibration products, quality control products, cleaning solutions, and reaction cups. Otherwise, adding consumables in the future will increase costs.