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Please Note: Products marked with an asterisk (*) are only available outside of the United States.

AcroMetrix Products

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HBV DNA Validation Kit

HBV Validation Kits offer a complete package of standards, controls and a protocol for assessing the analytical performance of nucleic acid test (NAT) procedures that test for Hepatitis B Virus (HBV) DNA. Each kit contains OptiQuant® Panels, OptiQual® Controls and a protocol that includes step-by-step instructions and guidance in data analysis.

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OptiQuant® HBV DNA Quantification Panel

OptiQuant® HBV DNA Quantification Panels provide a consistent, linear standard across multiple test methods, enabling clinical laboratories and diagnostic manufacturers to assess the performance of nucleic acid test procedures for the qualitative and quantitative determination of Hepatitis B Virus (HBV) DNA.

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ValiQuant™ HBV DNA Quantification Panel

ValiQuant™ HBV DNA Quantification Panels offer the largest dynamic range available for quantitative Hepatitis B Virus (HBV) DNA assays. Use the panel to establish or verify performance specifications for accuracy, precision, reportable range, and analytical specificity and sensitivity. The panel may also be used for training and proficiency testing of laboratory personnel.

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OptiQual® HBV DNA Controls

OptiQual® HBV DNA Controls assist in monitoring over time the performance of nucleic acid test procedures for the determination of Hepatitis B Virus (HBV) DNA. These controls have been carefully formulated to mimic patient samples and are traceable to the World Health Organization (WHO) International Standard for HBV DNA.

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NAC HBV DNA Controls

(Available outside the US only)

NAC HBV DNA Controls assist in monitoring over time the performance of nucleic acid test procedures for the determination of Hepatitis B Virus (HBV) DNA. These whole virus controls have been carefully formulated to mimic patient samples and are traceable to the World Health Organization (WHO) International Standard for HBV DNA.

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HCV RNA Validation Kit

HCV Validation Kits offer a complete package of standards, controls and a protocol for assessing the analytical performance of nucleic acid test (NAT) procedures that test for Hepatitis C Virus (HCV) RNA. Each kit contains OptiQuant® Panels, OptiQual® Controls and a protocol that contains step-by-step instructions and guidance in data analysis.

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OptiQuant® HCV RNA Quantification Panel

The OptiQuant® HCV RNA Quantification Panel provides a consistent, linear standard across multiple test methods, enabling clinical laboratories and diagnostic manufacturers to assess the performance of nucleic acid test procedures for the qualitative and quantitative determination of Hepatitis C Virus (HCV) RNA.

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OptiQual® HCV Genotype Panel

The OptiQual® HCV Genotyping Panel is intended for use in the identification of different genetic variants (genotypes) of Hepatitis C Virus (HCV). This well-characterized panel allows laboratories to compare new HCV genotype test procedures, and demonstrate assay performance.

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OptiQual® HCV RNA Controls

OptiQual® HCV RNA Controls assist in monitoring over time the performance of nucleic acid test procedures for the determination of Hepatitis C Virus (HCV) RNA. These whole virus controls are carefully formulated to mimic patient samples and are traceable to the World Health Organization (WHO) International Standard for HCV RNA.

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NAC HCV RNA Controls

(Available outside the US only)

NAC HCV RNA Controls assist in monitoring over time the performance of nucleic acid test procedures for the determination of Hepatitis C Virus (HCV) RNA. These whole virus controls are carefully formulated to mimic patient samples and are traceable to the World Health Organization (WHO) International Standard for HCV RNA.

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HIV-1 RNA Validation Kit

HIV-1 Validation Kits offer a complete package of standards, controls and a protocol for assessing the analytical performance of nucleic acid test (NAT) procedures that test for HIV-1 RNA. Each kit contains OptiQuant® Panels, OptiQual® Controls and a protocol that contains step-by-step instructions and guidance in data analysis.

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OptiQuant® HIV-1 RNA Quantification Panel

The OptiQuant® HIV-1 RNA Quantification Panel provides a consistent, linear standard across multiple test methods, enabling clinical laboratories and diagnostic manufacturers to assess the performance of nucleic acid test procedures for the qualitative and quantitative determination of HIV-1 RNA. Panel members contain whole HIV-1 virus diluted in EDTA-based normal human plasma.

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ValiQuant™ HIV-1 RNA Quantification Panel

The ValiQuant™ HIV-1 RNA Quantification Panel is composed of seven members containing HIV-1 RNA diluted in EDTA-based normal human plasma. Use the panel to establish or verify performance specifications for accuracy, precision, reportable range, and analytical specificity and sensitivity. The panel may also be used for training and proficiency testing of laboratory personnel.

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OptiQual® HIV-1 RNA Controls

The OptiQual® HIV-1 RNA Controls assist in monitoring over time the performance of nucleic acid test procedures for the determination of HIV-1 RNA. These controls contain inactivated HIV-1 positive plasma diluted in EDTA-based normal human plasma in order to closely mimic a patient sample. They are traceable to the World Health Organization (WHO) 2nd International Standard for HIV-1 RNA.

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OptiQual® HIV-1 RNA High Control

The OptiQual® HIV-1 High Control provides the highest concentration available to help monitor the performance of the upper dynamic range of quantitative real time HIV-1 NAT assays. This control contains the non-infectious 8E5 HIV-1 strain to provide maximum safety in the lab, and it provides results traceable to the World Health Organization (WHO) 2nd International Standard for HIV-1 RNA.

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OptiQual® HIV-1 Genotype Control:
RT/PR Mutant 1

The OptiQual® HIV-1 Genotype Control, RT/PR Mutant 1 is intended for use in assessing the performance of commercially available and laboratory developed test procedures designed to identify drug resistant genotypes of HIV-1. These controls have been carefully formulated to mimic naturally occurring specimens containing one or more drug resistance mutations in the HIV-1 genome.

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NAC HIV-1 RNA Controls

(Available outside the US only)

The NAC HIV-1 RNA Controls assist in monitoring over time the performance of nucleic acid test procedures for the determination of HIV-1 RNA. These controls contain inactivated HIV-1 positive plasma diluted in normal human plasma in order to closely mimic a patient sample.

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EBV DNA Validation Kit

EBV Validation Kits offer a complete package of standards, controls and a protocol for assessing the analytical performance of nucleic acid test (NAT) procedures that test for Epstein-Barr Virus (EBV) DNA. Each kit contains OptiQuant® Panels, OptiQual® Controls and a protocol that contains step-by-step instructions and guidance in data analysis.

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OptiQuant® EBV DNA Quantification Panel

The OptiQuant® EBV DNA Quantification Panel provides a consistent, linear standard across multiple test methods, enabling clinical laboratories and diagnostic manufacturers to assess the performance of nucleic acid test procedures for the qualitative and quantitative determination of Epstein-Barr Virus (EBV) DNA. Panel members contain quantitative dilutions of EBV in a proprietary matrix designed to closely mimic cerebrospinal fluid (CSF).

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OptiQual® EBV DNA Controls

The OptiQual® EBV DNA Controls assist in monitoring over time the performance of nucleic acid test procedures for the determination of Epstein-Barr Virus (EBV) DNA. Each positive control contains active virus that is diluted in a proprietary physiological matrix that mimics naturally occurring human specimens containing EBV DNA found in cerebrospinal fluid (CSF).

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CMV DNA Validation Kit

CMV Validation Kits offer a complete package of standards, controls and a protocol for assessing the analytical performance of nucleic acid test (NAT) procedures that test for human cytomegalovirus (CMV) DNA. Each kit contains OptiQuant® Panels, OptiQual® Controls and a protocol that contains step-by-step instructions and guidance in data analysis.

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OptiQuant® CMV DNA Quantification Panel

The OptiQuant® CMV DNA Quantification Panel provides a consistent, linear standard across multiple test methods, enabling clinical laboratories and diagnostic manufacturers to assess the performance of nucleic acid test procedures for the qualitative and quantitative determination of human cytomegalovirus (CMV) DNA.

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OptiQual® CMV DNA Controls

The OptiQual® CMV DNA Controls assist in monitoring over time the performance of nucleic acid test procedures for the determination of human cytomegalovirus (CMV) DNA. These controls have been carefully formulated to mimic naturally occurring human specimens, and can be used to monitor all procedural steps in any test procedure designed for measuring CMV DNA in human serum, plasma or whole blood.

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OptiQual® HSV-1 DNA Controls

The OptiQual® HSV-1 DNA Controls assist in monitoring over time the performance of nucleic acid test procedures for the determination of Herpes Simplex Virus-1 (HSV-1) DNA. Each positive control contains active virus that is diluted in a proprietary physiological matrix that mimics naturally occurring human specimens containing HSV-1 DNA found in cerebrospinal fluid (CSF).

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OptiQual® HSV-2 DNA Controls

The OptiQual® HSV-2 DNA Controls assist in monitoring over time the performance of nucleic acid test procedures for the determination of Herpes Simplex Virus-2 (HSV-2) DNA. Each positive control contains active virus that is diluted in a proprietary physiological matrix that mimics naturally occurring human specimens containing HSV-2 DNA found in cerebrospinal fluid (CSF).

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OptiQual® HPV DNA Control

The OptiQual® HPV DNA Control assists in monitoring over time the performance of nucleic acid test procedures that test for Human Papillomavirus (HPV) DNA. This control consists of human cells containing high risk HPV genotype 16 DNA, and is compatible with specimens that are obtained through Pap smears or biopsies and preserved in Cytyc ThinPrep® Pap Test™ PreservCyt® Solution.

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OptiQual® HPV Genotype Panel

The OptiQual® HPV Genotype Panel assists users in assessing the analytical performance of molecular diagnostic test procedures designed to detect different HPV genotypes. Each panel member contains whole cells with an integrated HPV genome, expressing the E6/E7 mRNA and thus mimicking a true oncogenic patient sample for full process control. Additionally, each panel member is sold separately, enabling users to select the specific panel members needed to fulfill a laboratory’s quality requirements. The panel members are manufactured in accordance with ISO 17511, providing excellent consistency and reproducibility in results from lot to lot.

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OptiQual® Enterovirus Controls

The OptiQual® Enterovirus Low Positive Control is the first ready-to-use external run control intended for use in assessing the performance of nucleic acid test procedures for the qualitative determination of Enterovirus RNA. OptiQual® EV Low Positive Control is the first standardized control in the field of Enterovirus testing, with units expressed in Enterovirus Units per milliliter (EVU/mL).

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OptiQual® MRSA DNA Control

OptiQual® MRSA Positive DNA Control is the first standardized External Quality Control for Methicillin Resistant Staphylococcus aureas (MRSA) molecular testing. The “non-sticky” strain used in OptiQual® MRSA Positive Control is less likely to clump together or adhere to surfaces, making this control more consistent from run to run, and safer to use.

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PeliSpy MultiMarker Control

(Available outside the US only)

PeliSpy Multi-Marker Run Controls are intended for use in assessing the performance of immunoassay test procedures for the qualitative determination of HBsAg, anti-HIV, anti-HBc, anti-HCV, anti-HTLV-I and anti-HTLV-I/II. Each Type contains a unique formula that is optimized for a particular assay system.

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PeliCheck HBsAg Panel

The PeliCheck HBsAg reference panel is intended for sensitivity evaluation of procedures for the detection of hepatitis B surface antigen (HBsAg). PeliCheck HBsAg reference panels were designed for use as a tool for validation and training of operators.

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PeliCheck anti-HCV Panel

The PeliCheck anti-HCV reference panel is intended for sensitivity evaluation of procedures for the detection of antibodies against Hepatitis C virus (HCV). PeliCheck anti-HCV reference panels were designed for use as a tool for validation and training of operators.

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PeliCheck anti-HIV-1/2 Panel

The PeliCheck anti-HIV reference panel is intended for sensitivity evaluation of procedures for the detection of antibodies against Human Immunodeficiency Virus-1 (HIV-1) and Human Immunodeficiency Virus-2 (HIV-2). PeliCheck anti-HIV reference panels were designed for use as a tool for validation and training of operators.

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PeliCheck anti-HTLV-I/II Panel

The PeliCheck anti-HTLV reference panel is intended for sensitivity evaluation of procedures for the detection of antibodies against human T-cell leukemia virus type I and II (anti-HTLV I/II). PeliCheck anti-HTLV reference panels were designed for use as a tool for validation and training of operators.

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OptiChallenge™ Inhibition Panel

The OptiChallenge™ Inhibition Panel seven member panel is the first to provide quantified amounts of commonly recognized and accepted inhibitors including heparin, lipids, bilirubin, and haemolyzed plasma. This panel can be used in a variety of ways, including assay validation, instrument evaluation, commercial and in-house assay characterization, and troubleshooting.

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OptiQual® Negative Control

The OptiQual® Negative Control provides clinical laboratories and diagnostic test manufacturers with a well-characterized, pre-screened negative specimen for use in the evaluation and quality control of nucleic acid test procedures. The control contains plasma that was previously tested and found to be negative for HCV RNA, HBV DNA, HIV-1 RNA, antibodies to HIV-1 and HIV-2, HBsAg, antibodies to HCV, and antibodies to HTLV I/II.

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VeriSure Pro Negative Control

The VeriSure® Pro Negative Control is intended to provide a means of estimating precision and reproducibility of nucleic acid tests, and can assist in identifying increases in random or systematic error. VeriSure® Pro Negative Control was previously tested and found to be negative for HBV DNA, HCV RNA, HIV-1 RNA, West Nile Virus (WNV) RNA, antibodies to HIV-1 and HIV-2, HBsAg, antibodies to HCV and antibodies to HTLV I-II.

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PeliSpy® Pro Negative Control

(Available outside the US only)

The PeliSpy® Pro Negative Control is intended to provide a means of estimating precision and reproducibility of nucleic acid tests, and can assist in identifying increases in random or systematic error. PeliSpy® Pro Negative Control was previously tested and found to be negative for HBV DNA, HCV RNA, HIV-1 RNA, West Nile Virus (WNV) RNA, antibodies to HIV-1 and HIV-2, HBsAg, antibodies to HCV and antibodies to HTLV I-II.

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VeriSure® Pro HBV Control

VeriSure® Pro HBV DNA External Quality Control is intended to provide a means of estimating precision and reproducibility of nucleic acid tests for detection of Hepatitis B Virus (HBV) DNA. Developed to closely resemble a donor sample, this control is ready to use on automated assay systems and contains whole, inactivated virus to monitor for the entire NAT process, from extraction to amplification and detection.

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PeliSpy® Pro HBV Control

(Available outside the US only)

PeliSpy® Pro HBV DNA External Quality Control is intended to provide a means of estimating precision and reproducibility of nucleic acid tests for detection of Hepatitis B Virus (HBV) DNA. Developed to closely resemble a donor sample, this control is ready to use on automated assay systems and contains whole, inactivated virus to monitor for the entire NAT process, from extraction to amplification and detection.

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VeriSure® Pro HCV Control

VeriSure® Pro HCV RNA External Quality Control is intended to provide a means of estimating precision and reproducibility of nucleic acid tests for detection of Hepatitis C Virus (HCV) RNA. Developed to closely resemble a donor sample, this control is ready to use on automated assay systems and contains whole, inactivated virus to monitor for the entire NAT process, from extraction to amplification and detection.

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PeliSpy® Pro HCV Control

(Available outside the US only)

PeliSpy® Pro HCV RNA External Quality Control is intended to provide a means of estimating precision and reproducibility of nucleic acid tests for detection of Hepatitis C Virus (HCV) RNA. Developed to closely resemble a donor sample, this control is ready to use on automated assay systems and contains whole, inactivated virus to monitor for the entire NAT process, from extraction to amplification and detection.

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VeriSure® Pro HIV-1 Control

VeriSure® Pro HIV-1 RNA External Quality Control is intended to provide a means of estimating precision and reproducibility of nucleic acid tests for detection of HIV-1 RNA. Developed to closely resemble a donor sample, this control is ready to use on automated assay systems and contains whole, inactivated virus to monitor for the entire NAT process, from extraction to amplification and detection.

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PeliSpy® Pro HIV-1 Control

(Available outside the US only)

PeliSpy® Pro HIV-1 RNA External Quality Control is intended to provide a means of estimating precision and reproducibility of nucleic acid tests for detection of HIV-1 RNA. Developed to closely resemble a donor sample, this control is ready to use on automated assay systems and contains whole, inactivated virus to monitor for the entire NAT process, from extraction to amplification and detection.

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VeriSure® Triplex HCV/HBV/HIV-1 Control

The VeriSure® Triplex HIV-1/HCV/HBV External Quality Control was developed for use with qualitative assays for the detection of HIV-1 RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA, respectively. This control intended to provide a means of estimating accuracy, and has the potential for detecting systematic deviations of nucleic acid test procedures.

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Blood Bank Training Panel

The Blood Bank Training Panel is designed for use in operator training assessment, assay performance evaluation, and comparing results across platforms and laboratories that test for HIV-1 RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA. These Training Panels can be used along with VeriSure® Pro external run controls as part of a complete quality control program.

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MPx Operator Training Panel

The MPx Operator Training Panel can be used to train laboratory personnel on the s201 Taqscreen MPX and Ampliscreen Resolution testing. The three panel members contain target materials for HIV-1, HCV, and HBV, and are intended to be used to simulate positive patient samples through the entire MPx assay process.

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VeriSure® Pro WNV RNA Controls

VeriSure® Pro WNV RNA Positive and Negative External Quality Controls are intended to provide a means of estimating precision and reproducibility of nucleic acid tests for detection of West Nile Virus (WNV) RNA. Developed to closely resemble a donor sample, these controls are ready to use on automated assay systems and help to monitor for the entire NAT process, from extraction to amplification and detection.

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WNV Training Panel

The WNV Training Panel is designed for use in operator training assessment, assay performance evaluation, and comparing results across platforms and laboratories that test for West Nile Virus (WNV) RNA. These Training Panels can be used along with VeriSure® Pro WNV external run controls as part of a complete quality control program.

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PeliSpy Multi-Marker Controls

(Available outside the US only)

PeliSpy Multi-Marker Run Controls are intended for use in assessing the performance of immunoassay test procedures for the qualitative determination of HBsAg, anti-HIV, anti-HBc, anti-HCV, and anti-HTLV-I/II. Each Type contains a unique formula that is optimized for a particular assay system.

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Dilution Matrix

NAT Dilution Matrix provides manufacturing firms, clinical laboratories, and blood banks with well-characterized, pre-screened negative diluent for use in making these preliminary dilutions. The use of a standard dilution matrix also allows testing laboratories and other end users to compare results obtained at different times, by different operators, or by different methodologies, and ensure that the sample diluent is not contributing to testing variability. NAT Dilution Matrix contains defibrinated, delipidized normal human plasma screened for HBV DNA, HCV RNA, HIV-1 RNA, antibodies to HIV-1 and HIV-2, HIV-1 antigen, HBsAg, antibodies to HCV and HTLV I - II.

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OptiMatrix Ultra

OptiMatrix Ultra is a defibrinated and delipidized normal human plasma based matrix that has been specifically designed to limit naturally occurring materials that may have an affect on assay results. OptiMatrix is intended for use in the laboratory environment when preparing specimens for plasma based analysis. It has been tested and found non-reactive for HBsAg, anti-HBc, anti-HBs, anti-HCV, anti-HIV-1 group O, anti-HIV-2, anti-HTLV I/II, as well as for HBV DNA, HCV RNA, and HIV-1 RNA.

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OptiMatrix

OptiMatrix is an EDTA-based normal human plasma matrix that closely mimics human fresh, frozen plasma. OptiMatrix is intended for use in the laboratory environment when preparing specimens for plasma based analysis. It has been tested and found non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, anti-HIV-1/2, HBsAg, anti-HBc, anti-HBs, anti-HCV and anti-HTLV I/II.

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EDCNet

EDCNet (Electronic Data Collection – internet-based reporting) provides a subscriber the ability to directly enter and then graph data generated from quality control (QC) results used to monitor serological or nucleic acid tests. EDCNet has the following objectives:

  • Built-in validation rules to minimize incorrect data entry
  • Customized screens to a given laboratory’s testing protocol
  • Shewart (Levy-Jennings) charts
  • Early detection of QC result trends
  • Vertical scatter graphs for comparison of results between laboratories
  • Vertical bar graphs for the evaluation of assay performance
  • Tabular reports for storage of hard copy reports

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OptiQual® HHV DNA Negative Control

The OptiQual HHV DNA Negative Control is a well-characterized, pre-screened negative specimen intended for use in assessing the performance of nucleic acid test procedures for the determination of Human Herpes Viruses. The product is a proprietary physiological buffer system that is negative for antibodies to HIV-1/2, HBsAg, and for HSV-1, HSV-2, and EBV DNA.

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OptiQual® Enterovirus Controls (CE)

(Available outside the US and Canada only)

The OptiQual Enterovirus Positive and Negative Controls are the first ready-to-use external run controls intended for use in assessing the performance of nucleic acid test procedures for determination of Enterovirus RNA. Units are expressed in EVU established in accordance with ISO 17511, which allows for the standardised comparison of test results across laboratories, assays, and manufacturers.

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OptiQuant® CMVtc Calibration Panel

A scientific study using the OptiQuant® CMVtc Calibration Panel demonstrated that a common calibrator for CMV DNA assays needs to be commutable, or behave like a patient sample, in order to ensure results for patients’ samples will be comparable independent of the medical laboratory that produced the results. The OptiQuant® CMVtc DNA Calibration Panel provides traceable results in accordance with ISO 17511 and is shown to be commutable between different CMV DNA assays.

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OptiQuant®-S HCV Quantification Panel

Based on the revolutionary SynTura™ Technology, the OptiQuant-S HCV Quantification panel provides laboratories with the largest reportable range commercially available and is developed for use on various automated HCV NAT systems. Use the OptiQuant-S HCV panel to establish or verify performance specifications for accuracy, precision, reportable range, and analytical sensitivity and specificity.

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OptiQual MSSA Positive Control

OptiQual MSSA Positive Control is the first standardized quality control for MSSA molecular testing, and may be used to independently ensure accuracy and precision through all phases of MSSA DNA testing. This control can also be used as a negative specificity control for MRSA testing, monitoring whether the assay is specific for the mecA gene that distinguishes MRSA from MSSA. This convenient, ready to use product contains whole MSSA bacterial particles, providing a safe method of monitoring the entire PCR process including the extraction procedure.

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OptiQual GBS Positive Control

As the first standardized control for molecular GBS testing, the OptiQual GBS Positive Control is used to assess the performance of qualitative molecular tests, thus helping laboratories fulfill CLIA guidelines. The OptiQual GBS Positive Control accurately monitors consistency of nucleic acid testing results over time and across reagent lots, assay formats, assay platforms, testing laboratories, and operators.

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Custom Products

AcroMetrix provides a variety of custom solutions targeted to meet your specific needs not addressed by our Catalog products:

  • Assay controls (Internal control, External control)
  • Development panels (Linearity, Limit of Detection, …)
  • Clinical studies Control materials
  • Lot release QC materials
  • Commercial implementation materials used for Validation, Verification, Training, Troubleshooting, Certification

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OptiQuant BKV Quantification Panel

The OptiQuant® BKV Quantification Panel is designed to help clinical laboratories assess the performance of molecular diagnostic test procedures for the determination of BK virus DNA. The panel features a wide dynamic range, effectively mimics a true patient sample, and is manufactured in accordance with ISO Standard 17511 to ensure consistent and reproducible results.

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OptiQuant 2009 H1N1 Quantification Panel

The OptiQuant 2009 H1N1 Quantification Panel is intended for use as a standard to assess the performance of quantitative and qualitative molecular diagnostic test procedures for 2009 H1N1 determination. 2009 H1N1 is a novel strain of influenza detected first in April of 2009, and molecular testing is recommended to distinguish this strain from seasonal influenza. This product is For Research Use Only. Not for use in diagnostic procedures.

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OptiQual® 2009 H1N1 Positive Control

The OptiQual 2009 H1N1 Positive Control is intended for use in assessing the performance of nucleic acid test procedures for the determination of 2009 H1N1. 2009 H1N1 is a novel strain of influenza detected first in April of 2009, and molecular testing is recommended to distinguish this strain from seasonal influenza. This product is For Research Use Only. Not for use in diagnostic procedures.

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OptiQual® Respiratory Negative Control

The OptiQual Respiratory Negative Control is intended for use in assessing the performance of nucleic acid test procedures for the determination of the presence of Respiratory viruses. Routine use of external run controls enables laboratories to monitor day-to-day test variation, lot-to-lot performance of test kits, and operator variation, and can assist in identifying increases in random systematic error. This product is For Research Use Only. Not for use in diagnostic procedures.

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