诊断血清盘
血清转换盘
我们的血清转换盘 是从未加工的血浆开发的,通过在感染演变过程中和随之而来的免疫反应采集个体血浆来实现的。我们的血清转换盘包含明确的感染标志物,并包含广泛的样本测试数据,可用于比较和分析。
我们的 血清转换盘旨在被诊断制造商和研究人员在分析开发、评估、故障排除以及IgM/IgG抗体测试系统和方法的后续监测中使用。此外,这些血清盘还可作为诊断灵敏度的验证工具,用于测量分析灵敏度、确定临界值或研究特定感染的体液免疫反应。
在这里,您可以找到多种具有高质量数据集产品,帮助您评估检测方法:
抗凝剂血清盘
抗凝剂血清盘用于揭示各种抗凝剂对检测结果的潜在影响。可从健康供体中获得5个或10个样本的抗凝剂血清盘。我们也很乐意应客户要求接受任何抗凝剂血清盘。所有供体均通过 CE 认证的测试,抗 HIV、抗HCV 和 乙肝表面抗原 的检测结果均为阴性/无反应。
当然,我们也为您进行样品储存稳定性研究–请使用我们的服务来完成您的项目。
Order no. | Product description | Volumes |
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MSS-005 (5 sample sets) MSS-010 (10 sample sets) or MSS-XXX (customized) | Matched sets small Serum Sodium citrate K2EDTA Lithium heparin | 1.0 mL |
MSS-005 (5 sample sets) MSS-010 (10 sample sets) or MSS-XXX (customized) | Matched sets large* Serum Sodium citrate K2EDTA K3EDTA Sodium heparin Lithium heparin ACD-B CPDA K-oxalate / Na-fluoride | 1.0 mL |
* or contract production
CS 筛选测试盘
CS筛查测试盘用于满足2017/746(IVDR)下D类设备的要求。有关IVDR的更多信息可以在这里找到。
血清转换检测板始于阴性收集,并具有密集的收集间隔。
如果您对IVDR有进一步的问题或需要帮助实施相关要求,请联系我们。
诊断灵敏性检测盘
Order. no. | Panel | Product description | |
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Panels for screening tests (acc. to Table 1, CTS): | |||
CTS-HIV | Anti-HIV 1/2 panel | 400 Anti-HIV 1 positive samples with • 40 non-B-subtypes (in each case at least 3 samples of the subtypes A, C, D, F, G, H, J, K, CRF01_AE, CRF02_AG, CRF06_cpx3, CRF11_cpx and group O) • 3 subtypes B • 357 Anti-HIV 1 samples unspecified 100 Anti-HIV 2 samples | |
CTS-HIV | 30 HIV seroconversion panels | All seroconversion samples include established positives (they are p24 antigen and/or HIV RNA positive, established/detected by antibody screening (verification) tests and determined to be positive or undetermined by means of confirmatory tests), and include at least 40 early HIV seroconversion samples (these are p24 antigen and/or HIV RNA positive, not established/determined by antibody screening tests and determined as undetermined or negative using confirmatory tests) | |
CTS-HCV | Anti-HCV panel | 400 Anti-HCV positive samples with • 21 of genotype 1 • 21 of genotype 2 • 21 of genotype 3 • 21 of genotype 4 • 21 of genotype 4 not subtype A • 5 of genotype 5 • 280 HCV samples unspecified | |
CTS-HCV | 30 HCV seroconversion panels | ||
CTS-HBsAg | HBsAg Panel | 400 HBsAg positive samples with the different subtypes A1, A2, B1, B2, C1, C2, D1-7, E, F1-4, G, H | |
CTS-HBsAg | 30 HBV seroconversion panels |
诊断特异性检测盘
Order no. | Panels | Product description | |
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CTS-BDP | Blood donor panels | 5000 (screening test) or 1000 (rapid test) samples from unselected blood donors from at least 2 different European donation centers | |
CTS-HPP | Hospitalized patient panels | 200 samples from patients suffering from severe illness and on medication | |
Cross-reaction panels More than 100 samples containing cross-reacting substances such as RF +, autoimmune antibodies, EBV, CMV, hepatitis samples, etc. | |||
General test panels | RF +, HAMA, pregnant women, multipara, hyper-IgM, hyper-IgG, dialysis patients, influenza vaccinated individuals, etc. 30 samples (in each case 3 samples) | ||
Blood bank marker panels | Anti-HIV 1, Anti-HCV, HBsAg, Anti-Syphilis etc. 15 samples (in each case 3 samples) | ||
Herpes panels | Anti-HSV 1, Anti-HSV 2, Anti-VZV, Anti-EBV, Anti-CMV 15 samples (in each case 3 samples) | ||
Hepatitis panels | Anti-HAV, Anti-HBs, Anti-HBc, Anti-HEV 12 samples (in each case 3 samples) | ||
Inhibition panels | Hemolytic, lipemic and icteric samples, low, mid and high concentration in addition to a negative control 36 samples (in each case 3 samples) | ||
Serum / plasma equivalence panels In the case of products intended by the manufacturer for testing serum and plasma, the serum-plasma equivalence must be confirmed in the performance evaluation. Evidence must be provided from at least 50 donations (25 positive and 25 negative). | |||
25 negative matched sets | Serum, plasma (including all anticoagulants that might be used) |
CS 核酸检测盘
CS筛查测试盘用于满足2017/746(IVDR)下D类设备的要求。有关IVDR的更多信息可以在这里找到。
如果您对IVDR有进一步的问题或需要帮助实施相关要求,请联系我们。
诊断灵敏性检测盘
Order no. | Panels | Product description |
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Panel for NAT testing (according to Table 2 CS): Panel for Genotype/Subtype Detection/Quantification Efficiency |
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NAT-HIV | NAT-HIV 1 Panel | 10 samples of each subtype |
NAT-HCV | NAT-HCV Panel | 10 samples of each genotype |
NAT-HBV | NAT-HBV Panel | 10 samples of each subtype |
Seroconversion panel | ||
For qualitative PCR tests, diagnostic sensitivity must be evaluated on at least 10 seroconversion panels. They start with (a) negative collection(s) and have narrow collection intervals. |
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10 HIV Seroconversion panel | ||
10 HCV Seroconversion panel | ||
10 HBV Seroconversion panel |
诊断特异性检测盘
Order no. | Panels | Product description |
---|---|---|
NAT-BDP | Blood donor panel | 500 samples of unselected blood donors (from at least 2 different European donation centers) for qualitative testing or 100 samples of unselected blood donors for quantitative testing. |
NAT-HPP | Hospital-patients panel | 200 samples from patients suffering from severe diseases and under medication. |
Cross contamination panel To investigate possible carryover, at least five test series with alternating high positive and negative samples during robustness testing. The high positive samples contain samples with high viral load. |
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CCP-HIV | NAT-HIV Kreuzkontaminationspanel | 5 HIV samples with high titer and 5 negative samples |
CCP-HCV | NAT-HCV Kreuzkontaminationspanel | 5 HCV samples with high titer and 5 negative samples |
CCP-HBV | NAT-HBV Kreuzkontaminationspanel | 5 HBV samples with high titer and 5 negative samples |
Cross-Reactivity Panel By demonstrating an appropriate test design (e.g., sequence comparison) and/or testing on at least 10 specimens, Positive for human samples with related viral infection. |
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CRP-HIV | NAT-HIV Cross-Reactivity Panel | 10 human retrovirus positive samples (e.g. HTLV) |
CRP-HCV | NAT-HCV Cross-Reactivity Panel | 10 human flavivirus positive samples (e.g. HGV, YFV). |
CRP-HBV | NAT-HBV Cross-Reactivity Panel | 10 human DNA virus positive samples |
Serum Plasma Equivalent Panel For devices intended by the manufacturer to be tested in serum and plasma, serum-to-plasma correspondence must be demonstrated in the performance evaluation. Evidence must be provided on at least 50 donations (25 positive and 25 negative). |
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25 negative Matched Sets | Serum, plasma (including any anticoagulants that may be used). |
抑制血清盘
溶血、脂血和黄疸标本抑制血清盘用于检测诊断化验中因血清、血浆或全血标本中常见的干扰物质而产生的抑制效应。可提供不同的抑制血清盘规格: 5 份、10 份或更多份来自正常健康供血者的样本。我们可为您量身定制解决方案。
Order no. | Components (matrix: EDTA) | Concentration range | Quantity | |
---|---|---|---|---|
IHH-005 (5 sample sets) IHH-010 (10 sample sets) or IHH-XXX (customized) | Hemolytic negative control Hemolytic plasma low* Hemolytic plasma medium* Hemolytic plasma high* | 0.0 - 0.1 mg/dL 0.5 - 0.7 mg/dL 0.9 - 1.1 mg/dL 1.9 - 2.2 mg/dL | 1.0 mL | |
Components (matrix: CPD) | ||||
IHL-005 (5 sample sets) IHL-010 (10 sample sets) or IHL-XXX (customized) | Lipaemic negative control Lipaemic plasma low* Lipaemic plasma medium* Lipaemic plasma high* | 50 - 199.9 mg/dL 200 - 399.9 mg/dL 400 - 800 mg/dL 400 - 800 mg/dL | 1.0 mL | |
Components (matrix: Serum) | ||||
IHI-005 (5 sample sets) IHI-010 (10 sample sets) or IHI-XXX (customized) | Icteric negative control** Icteric plasma low** Icteric plasma medium** Icteric plasma high** | to be defined 18 - 22 mg/dL 38 - 42 mg/dL 58 - 62 mg/dL | 1.0 mL | |
* native samples ** spiked samples |
干扰血清盘
我们的交叉反应血清盘可以选择各种潜在交叉反应物的特定组合。
干扰血清盘可提供不同的包装规格,可用于从健康供体采集一个(ABC-001)、五个(ABC-005)或十个(ABC-010)样本组。如果需要,我们还可以提供更大的包装单位(ABC-XXX)
我们为您量身定制解决方案。
Order no. | Product | Volumes |
---|---|---|
BTP-001 BTP-005 BTP-010 or BTP-XXX | General test panels • Rheumatoid factor • HAMA • Pregnant woman • Multipara • Hyper IgM, IgG • Dialysis patient • Recipient of an influenza vaccination (max. 6 months old) | 1.0 mL |
BBX-001 BBX-005 BBX-010 or BBX-XXX | Blood bank marker panels (3-pack, 6-pack, or made-to-order) • Anti-HIV 1 • Anti-HAV • Anti-HBs • Anti-HTLV I/II • Anti-HCV • Anti-Syphilis • Anti-HBc • HBsAg • Anti-CMV • Anti-Chagas … and more* | 1.0 mL |
HHV-001 HHV-005 HHV-010 or HHV-XXX | Herpes panels • Anti-HSV 1 • Anti-HSV 2 • Anti-VZV • Anti-EBV • Anti-CMV • Anti-HHV 6 • Anti-HHV 7 • Anti-HHV 8 | 1.0 mL |
HEPP-001 HEPP-005 HEPP-010 or HEP-XXX | Hepatitis panels • Anti-HAV • HBsAg • Anti-HBs • Anti-HBc • Anti-HCV • Anti-HEV | 1.0 mL |
NPP-001 NPP-005 NPP-010 or NPP-XXX | Negative plasma panels Can be used to check the specificity of tests • Anti-HIV • Anti-HBs/HBsAg • Anti-HCV • Anti-CMV • Anti-HTLV I/II • Anti-Syphilis … and more* According to the regulatory requirements up to 5000 individuals | 1.0 mL |
* or contract production |
其他的血清盘
BIOMEX 还提供多种其他类型的血清盘。如果您需要的特定血清盘未在此列出,请联系我们。我们很乐意为您量身定制
质控发放检测盘
质控发放检测盘(血清和血浆)
通过我们的供体收集中心以及与实验室机构的合作,BIOMEX 可以提供几乎所有参数的不同范围的现货产品。
质控发放检测盘可根据所需的范围和参数量身定制。
- 阳性 – 低、中、高范围
- 阴性 – 无分析物、无病毒、无特异性抗体
- 临界值 – 从 检测限界 到临床决策点的范围值
另请注意子页面,其中展示了我们广泛具有阳性感染标志物的人体生物样本。
或者借此机会直接在我们的数据库中搜索您想要的样品:
ZeptoMetrix 盘
北美公司 ZeptoMetrix® 是高质量血清转换盘的市场领导者之一,其产品性价比非常高。血清转换盘有助于诊断制造商、研究人员和临床实验室开发或评估新的检测方法,因此是质量控制和质量保证不可或缺的工具。血清转换试剂盒包含明确的感染标志物以及广泛的样本数据,可用于比较和分析。
BIOMEX 在欧洲独家销售 ZeptoMetrix® 产品组合。