Health Sciences Center, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.
Santa Catarina Hematology and Hemotherapy Center, Florianópolis, Santa Catarina, Brazil.
Transfus Med. 2024 Oct;34(5):428-436. doi: 10.1111/tme.13076. Epub 2024 Aug 9.
The storage temperature of immunohaematological reagents generally ranges from 2 to 8°C, and they should be utilised at room temperature. This study aimed to analyse the stability of immunohaematological reagents used in ABO and RhD typing.
The evaluation encompassed the potency, specificity, and integrity of anti-A, anti-B, anti-D, RhD control sera, and A and B red blood cells (RBC) reagents after long (8 h) and short (4 h) daily periods of exposure to room temperature (20-24°C), 5 days a week for 4 weeks. Additionally, the A and B RBC reagents were exposed daily for 11 h and 30 min at room temperature, including 30 more minutes at room temperature with simultaneous homogenisation through equipment. For the control, an aliquot of each reagent was constantly stored at refrigeration temperature, while another was exposed to room temperature for 12 h daily. Tests conducted included reaction intensity, titration, and avidity for antisera, reaction intensity, free haemoglobin determination, and electrical conductivity for the RBC reagents.
The antisera maintained the reaction intensity. The titre and avidity of the antisera satisfied the minimum Brazilian requirements after different exposure periods. A higher free haemoglobin concentration was noted in the RBC reagents subjected to room temperature and simultaneous homogenisation, although this did not affect the potency and specificity. The electrical conductivity average of the RBC reagent remained consistent.
The findings indicate that the immunohaematological reagents from a specific manufacturer are stable under the tested temperature, ensuring the quality of the results under these conditions.
免疫血液学试剂的储存温度一般在 2 到 8°C 之间，使用时应置于室温。本研究旨在分析 ABO 和 RhD 定型中使用的免疫血液学试剂的稳定性。
评估包括抗-A、抗-B、抗-D、RhD 对照血清以及 A 和 B 红细胞（RBC）试剂在暴露于室温（20-24°C）下长达 8 小时和短至 4 小时的日常时间后，每周 5 天，每天 4 小时的效力、特异性和完整性。此外，A 和 B RBC 试剂每天在室温下暴露 11 小时 30 分钟，包括 30 分钟的同步均质化。对照品的一部分试剂始终冷藏保存，另一部分试剂每天在室温下暴露 12 小时。进行的测试包括血清的反应强度、滴定和亲和力，以及 RBC 试剂的反应强度、游离血红蛋白测定和电导率。
血清保持反应强度。经过不同的暴露期后，抗血清的效价和亲和力均满足巴西的最低要求。在室温下并同时进行均质化的 RBC 试剂中观察到较高的游离血红蛋白浓度，但这并未影响效力和特异性。RBC 试剂的电导率平均值保持一致。
研究结果表明，在测试温度下，特定制造商的免疫血液学试剂稳定，确保了在这些条件下的结果质量。
