是否无菌：是
本产品血源取自普通牛（Bos taurus，中国荷斯坦牛），为出生 14 小时内未进食初乳的健康新生牛，采用全程无菌密闭采血，单批可完整追溯牧场、检疫及采血记录；制备工艺为无菌密闭采血→恒温凝固→低温离心→亲和层析去除高干扰 IgG、溶血血红蛋白、游离激素、氧化酶→五级 0.1μm 串联终端过滤除菌→A 级层流无菌灌装→即时速冻入库，本品为特级 IVD 专用款，相较于普通细胞培养血清，具备低 IgG、低血红蛋白、低内毒素、低内源干扰杂蛋白、批间差异极小的优势，不会干扰 ELISA、胶体金、化学发光、生化诊断试剂的抗原抗体结合、显色及读数结果，可作为封闭液、酶稀释液、校准品 / 质控品的基础基质，拥有优异的稳定性。
适用范围
1. ELISA、化学发光、胶体金、免疫比浊等免疫诊断试剂盒封闭液配制；
2. 标记酶稀释液、抗体稀释液、样本稀释液基础原料；
3. 诊断试剂盒校准品、质控品、阳性 / 阴性对照品基础基质；
4. 体外免疫试验、阻断试验、中和试验配套基质。
诊断试剂专项验证
1. 低干扰验证：无内源干扰抗体、激素、氧化酶，不影响抗原 - 抗体特异性结合、显色终点读数；
2. 基质稳定性：可作为校准品、质控品基础基质，抗原 / 抗体长期保存稳定性良好；
3. 封闭性能：有效封闭固相载体非特异性结合位点，降低试剂盒背景值；
4. 酶保护性能：稀释标记酶时可稳定保护酶空间构象，维持酶活稳定
储存条件与有效期
1. 长期储存：-20℃避光密封冷冻保存；
2. 解冻后短期存放：2～8℃冷藏，1 个月内用完；
3. 完全培养基：血清配制完全培养液后，2～8℃一周内使用完毕；
4. 禁止：室温、37℃长时间放置，易造成生长因子失活、蛋白析出。
标准解冻与使用方法
1. 标准解冻流程
① 从 - 20℃取出血清，置于 2～8℃冷藏 12～24 h 预解冻；
② 剩余少量冰块转移至室温缓慢完全融化；
③ 融化过程每隔 30min 轻柔颠倒混匀，禁止剧烈摇晃；
④ 完全解冻后，可按需分装为小份冷冻，规避反复冻融损伤品质。
2. 诊断试剂配制添加比例参考
① 微孔板封闭液：基础缓冲液添加 5%～10%（V/V）；
② 酶标记物稀释液、抗体稀释液：添加 2%～5%（V/V）；
③ 校准品 / 质控品基质：添加 10%～20%（V/V）；
④ 更换血清生产批次前，必须开展试剂盒平行比对试验，确保检测数值、背景值无明显波动。
注意事项
1. 严禁反复冻融：多次冻融会产生大量蛋白絮状沉淀，提升试剂盒背景值，干扰显色读数；少量细微沉淀可 3000r/min 离心 10min 取上清使用。
2.分装、配制诊断试剂全程在 A 级洁净操作台无菌操作；取用后剩余血清不可倒回原瓶，防止整瓶污染。
3.热灭活说明：本品出厂已完成全套病毒去除工艺，诊断试剂生产无需 56℃热灭活；特殊试验需灭活补体时，56℃水浴 30min，每 5min 轻柔混匀，灭活后迅速冷却。
4.安全提示：本品仅用于体外诊断试剂研发、生产及体外实验室试验，严禁人或动物体内注射使用；操作全程佩戴一次性手套，皮肤、黏膜接触后立即清水冲洗。
5.批次管控：不同生产批次血清蛋白、IgG 含量存在细微天然差异，标准化试剂盒量产建议固定同一批号；更换批号必须完成试剂盒全性能比对验证。
6.废弃物处理：过期、污染血清经 121℃高压灭菌 30min 后，按生物废弃物规范处置，不得直接倾倒。
7.本品含动物源性蛋白，对牛源蛋白过敏人员操作需加强防护
声明
本品为科研试剂，仅供实验室研究使用。不可用于临床诊断、治疗或药物用途。使用者应具备相应的细 胞培养知识和实验技能。
Is it sterile: Yes
This product is sourced from healthy newborn Chinese Holstein cattle (Bos taurus) that have not ingested colostrum within 14 hours after birth. Full‑process sterile closed‑system blood collection is implemented, with complete traceability of pasture, quarantine and blood‑collection records available for each batch. The manufacturing process comprises sterile closed‑system blood collection, constant‑temperature coagulation, low‑temperature centrifugation, affinity chromatography for removal of high‑interference IgG, hemolytic hemoglobin, free hormones and oxidases, five‑stage 0.1 μm serial terminal filtration for sterilization, A‑grade laminar‑flow aseptic filling, followed by immediate quick‑freezing and warehousing. As a Premium‑Grade serum dedicated for IVD applications, compared with ordinary cell‑culture serum, it features low IgG, low hemoglobin, low endotoxin, low endogenous interfering heteroproteins and minimal batch‑to‑batch variation. It does not interfere with antigen‑antibody binding, color development and readout results of ELISA, colloidal gold, chemiluminescence and biochemical diagnostic reagents. It can serve as the base matrix for blocking solutions, enzyme diluents, calibrators and quality‑control materials with excellent stability.
Scope of Application
1. Preparation of blocking solutions for immunodiagnostic kits including ELISA, chemiluminescence, colloidal gold and immunoturbidimetry
2. Base raw material for labeled enzyme diluents, antibody diluents and sample diluents
3. Base matrix for calibrators, quality‑control materials, positive/negative controls of diagnostic kits
4. Supporting matrix for in‑vitro immunoassays, blocking assays and neutralization assays
Special Validation for Diagnostic Reagents
1. Low‑interference verification: Free of endogenous interfering antibodies, hormones and oxidases; does not affect specific antigen‑antibody binding and color‑development endpoint readouts.
2. Matrix stability: Suitable as base matrix for calibrators and quality‑control materials; favorable long‑term storage stability for antigens and antibodies.
3. Blocking performance: Effectively blocks non‑specific binding sites on solid‑phase carriers and reduces kit background values.
4. Enzyme‑protection performance: Stabilizes and protects the spatial conformation of labeled enzymes upon dilution and maintains stable enzyme activity.
Storage Conditions and Shelf‑life
1. Long‑term storage: Store sealed in the dark at −20 °C under frozen conditions.
2. Short‑term storage after thawing: Store at 2‑8 °C and use within 1 month.
3. Complete culture medium: After preparing complete medium with serum, use within one week at 2‑8 °C.
4. Prohibition: Avoid prolonged placement at room temperature or 37 °C, which may cause growth‑factor inactivation and protein precipitation.
Standard Thawing and Usage Protocols
1. Standard thawing procedure
① Remove serum from −20 °C and pre‑thaw at 2‑8 °C for 12‑24 h.
② Transfer serum with residual small ice cubes to room temperature for slow complete thawing.
③ Gently invert and mix every 30 min during thawing; violent shaking is prohibited.
④ Upon complete thawing, aliquot into small portions for frozen storage as required to prevent quality impairment caused by repeated freeze‑thaw cycles.
2. Reference addition ratios for diagnostic‑reagent preparation
① Microplate blocking solution: Add 5%‑10% (V/V) serum to base buffer.
② Enzyme‑labeled conjugate diluent and antibody diluent: Add 2%‑5% (V/V).
③ Calibrator / quality‑control matrix: Add 10%‑20% (V/V).
④ Prior to switching serum production batches, parallel kit comparison tests must be performed to ensure no significant fluctuation in detection values and background values.
Precautions
1. Repeated freeze‑thaw cycles are strictly prohibited. Multiple freeze‑thaw cycles generate substantial flocculent protein precipitates, which elevate kit background values and interfere with color‑development readouts. Minor fine precipitates may be removed by centrifugation at 3000 r/min for 10 min, and the supernatant can be used.
2. Perform aliquoting and diagnostic‑reagent preparation entirely on an A‑grade clean bench under aseptic conditions. Do not pour leftover serum back into the original bottle after use to prevent whole‑bottle contamination.
3. Heat‑inactivation note: This product has undergone complete virus‑removal treatment at manufacture; 56 °C heat‑inactivation is unnecessary for diagnostic‑reagent production. If complement inactivation is required for special experiments, perform water‑bath incubation at 56 °C for 30 min with gentle mixing every 5 min, then cool rapidly after inactivation.
4. Safety reminder: This product is only for R&D, production of in‑vitro diagnostic reagents and in‑vitro laboratory tests. Injection into human or animal bodies is strictly forbidden. Wear disposable gloves throughout operation; rinse skin and mucous membranes immediately with clean water upon contact.
5. Batch control: Natural subtle variations exist in serum protein and IgG contents across different production batches. Fixed‑batch usage is recommended for mass production of standardized kits. Full‑performance comparison and validation of kits must be completed upon batch change.
6. Waste disposal: Expired or contaminated serum shall be autoclaved at 121 °C for 30 min and disposed of in compliance with biological‑waste regulations; direct dumping is prohibited.
7. This product contains animal‑derived proteins. Personnel allergic to bovine‑origin proteins shall enhance protective measures during handling.
Disclaimer
This product is a research‑use reagent intended exclusively for laboratory research. It shall not be used for clinical diagnosis, therapy or pharmaceutical applications. Operators shall possess adequate knowledge and experimental skills for cell culture.
ZJ26F0938995
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