The new batch of antigen detection kits has a large difference between batches, how to design and verify to reduce the scrap rate?

Dual suppliers can be prepared, but it is best to classify and go online, it is not recommended to mix at the same time. Main batches are used to maintain stability, and alternative manufacturers do small batches of parallel verification, covering low-concentration positive, negative, matrix interference and continuous arrival stability, and then gradually introduced. 300 tubes per day can be stratified by risk: critical samples or suspected samples at low concentrations are used for backup or re-examination. The contract focuses on batch continuity, expiration date, cold chain transportation, change notice, and return and exchange. Within the unit price range, the selection dimension should focus on historical batch stability, quality control data, after-sales response, and on-site adaptation, rather than just looking at parameters.

The fading of the positive control line should not be directly attributed to the product, and it should be checked according to the samples, reagents, environment, and interpretation of the four lines. It is recommended that the validation protocol be combined: sample retention recovery is used for parallel duplication of the same weakly positive sample across batches; different matrix samples are used to evaluate swabs, preservatives, and cleavage interference. 300 tubes per day can establish a C/T or line grayscale baseline with a quality control card before going online, set an acceptable drift range, and trigger a retest or isolation batch number. Retain original photos or readings to count trends in batch differences. If it is indeed unstable between batches, the supplier is required to provide batch inspection, sample retention reinspection and change instructions.