Panels for Diagnostics
Panels for Diagnostics
Choose your panel either to be delivered from stock or to be customized upon request: Inhibition Panels, Interference Panels, Matched Sets, Q.C. Panels, Seroconversion Panels, and Standardization Panels.
Seroconversion Panels
Our Seroconversion Panels (SCPs) were developed from non-processed plasma. This was done by collecting plasma from an individual during the evolution of an infection, and the ensuing immunological response. Our seroconversion panels contain defined infection markers and include extensive sample data for comparative analysis.
Our SCPs are intended to be used in standard tests by diagnostic manufacturers and researchers during assay development, evaluation, troubleshooting, and post-monitoring of IgM/IgG antibody test systems and methods. In addition, these panels also serve as a validation tool for diagnostic sensitivity, for measuring analytical sensitivity, for identifying cut-off values, or for investigating the humoral immune response to a specific infection.
Matched Sets
The matched sets are used to reveal any potential influential effects of various anticoagulants on the test result. Available from healthy donors in panels of 5 or 10 samples. We would also be happy to accept any matched sets at the customer’s request. All donors are tested negative/non-reactive for anti-HIV, anti-HCV and HBsAg using CE certified tests.
Of course, we also conduct Sample Storage Stability Studies for you – use our service for your project.
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 Screening Test Panels
CS panels are used to meet the requirements under 2017/746 (IVDR), specified in the CS for Class D devices. More information on the IVDR can be found here.
Seroconversion panels start with (a) negative collection(s) and have narrow collection intervals.
If you have further questions about the IVDR or need assistance in implementing the requirements, please contact us.
Diagnostic Sensitivity Panels
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 |
Diagnostic Specificity Panels
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 NAT Panels
CS panels are used to meet the requirements under 2017/746 (IVDR), specified in the CS for Class D devices. More information on the IVDR can be found here.
If you have further questions about the IVDR or need assistance in implementing the requirements, please contact us.
Diagnostic Sensitivity Panels
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 |
Diagnostic Specificity Panels
Order no. | Panels | Product description |
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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). |
Inhibition Panels
The Inhibition Panels, hemolytic, lipemic and icteric specimens serve to detect inhibition effects in diagnostic assays that could occur as a result of interfering substances commonly found in serum, plasma or whole blood specimens. Available in different kit sizes: 5, 10 or more from normal healthy donors. We produce custom-made solutions for you.
Order no. | Components (matrix: EDTA) | Concentration range | Quantity | |
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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 |
Interference Panels
Our cross-reaction panels allow to select a specific combination of various potential cross-reactants.
The panels are available in different pack sizes for one (ABC-001), five (ABC-005) or ten (ABC-010) sample sets from healthy donors. If desired, we can also offer larger packaging units (ABC-XXX).
We produce custom-made solutions for you.
Order no. | Product | Volumes |
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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 |
Various Panels
BIOMEX offers a wide range of other panels. Contact us if you need a specific panel that is not listed here. We are happy to produce customized panels.
QC Release Panels
QC release panels (serum and plasma)
Through our donor collection centers and our cooperation with laboratory facilities BIOMEX provides almost all parameters with different ranges off the shelf.
The QC Release Panels are tailor made in the ranges and parameters that are required.
- Positive – low, medium, high range
- Negative – no analyte, no virus, no specific antibody
- Cut-off – values at range of LoD to clinical decision point
Please also note the subpage with our extensive range of human biosamples with positive infection markers.
Or use this opportunity to search for your desired sample directly in our database:
ZeptoMetrix Panel
The North American company ZeptoMetrix® is one of the market leaders for high quality seroconversion panels with a very favorable price-performance ratio. Seroconversion panels assist diagnostic manufacturers, researchers and clinical laboratories in the development or evaluation of new assays and are therefore an indispensable tool for quality control and quality assurance. The panels contain defined infection markers as well as extensive sample data for comparative analysis.
BIOMEX markets the ZeptoMetrix® product portfolio exclusively in Europe.