AMPLIRUN TOTAL A RELIABLE QUALITY CONTROL SOURCE FOR NUCLEIC ACID TESTS
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1 AMPLIRUN TOTAL A RELIABLE QUALITY CONTROL SOURCE FOR NUCLEIC ACID TESTS
2 Take Control, Molecular Control.
3 AMPLIRUN TOTAL RESPIRATORY INFECTIONS TUBERCULOSIS INFECTIONS GASTROINTESTINAL INFECTIONS MONONUCLEOSIS INFECTIONS SEXUALLY TRANSMITTED INFECTIONS TORCH INFECTIONS VECTOR-BORNE INFECTIONS AMPLIRUN TOTAL 1
4 FULL PROCESS CONTROLS DESIGNED TO MONITOR THE ACCURACY AND PRECISION OF THE COMPLETE ANALYTICAL PROCESS Nucleic Acid Extraction Amplification Data Analysis AmpliRun Total REGULATORY REQUIREMENTS REINFORCE THE NEED TO USE THIRD PARTY CONTROLS Use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer. ISO 15189:2012 Medical Laboratories. Requirements for Quality and competence. Controls independent of those produced by the manufacturer of the test or analyser should be used. National Association of Testing Authorities (NATA) Australia. AS 4633 (ISO 15189) Supplemental Requirements for accreditation in the field of Medical testing. Quality control materials should be different from the calibrator materials to ensure that the QC procedure provides an independent assessment of the measurement procedure s performance in its entirety, including the procedure for calibration of the measurement. Clinical and Laboratory Standards Institute (CLSI). C24-A3 Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline Third Edition, For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. Clinical Laboratory Improvement Amendments (CLIA). Code of Federal Regulations Title 42 Part 493 Laboratory requirements Standard: Control procedures.
5 AMPLIRUN TOTAL THIRD PARTY CONTROLS Achieve independent assessment of your diagnostic devices and methods, comply with lab accreditation and improve patient care. FEATURES Whole pathogen controls with complete genome. Quantified controls (low positive). Shelf life: up to 2,5 years from date of manufacture. Lyophilized presentation to ensure stability and avoid extra transport costs. Monodose format. Non-infectious microorganisms. For IVD use. MATRICES Applicable for a range of matrices: plasma, swab, sputum, exudate, urine, stool and CSF. MULTIPLE PLATFORM COMPATIBILITY GeneXpert (Cepheid), BD MAX (Becton Dickinson), Panther (Hologic), Filmarray (BioFire), or Liaison MDX (Diasorin Molecular), among others. CUSTOM SOLUTIONS Vircell R&D team has both the experience and capacity to design, develop, and deliver customized biological controls for all kind of instruments and assays. We can produce variations of the existing products in terms of concentration or purification requirements, or we can customize entire new panels to meet your unique needs. EXTERNAL RUN CONTROLS Vircell is a leading provider of independent external run controls for Nucleic Acid Testing (NAT) with a long-term trajectory in infectious disease diagnostics. AmpliRun Total Controls are designed to be used as run controls for routine customer use to guarantee efficient nucleic acid extraction, amplification and detection. These inactivated whole-organism positive controls are provided in a matrix that mimics different human samples formulated to produce low level positive results at a clinically significant concentration. The control should be extracted and amplified alongside unknown samples and treated in an identical manner to a clinical specimen. Each single-use vial is intended to help laboratories monitor and maintain consistent, accurate and meaningful performance of their molecular infectious diseases assays. Quality control practices are essential in the routine molecular diagnostic laboratories for infectious diseases to ensure accuracy and reproducibility of lab test results. Start guaranteeing today the integrity and confidence of your results with AmpliRun Total Controls. AMPLIRUN TOTAL 3
6 RESPIRATORY INFECTIONS AMPLIRUN TOTAL ATYPICAL BACTERIAL PNEUMONIA CONTROL (SWAB) Code: MBTC022 Analytes: Bordetella pertussis, Chlamydophila pneumoniae, Chlamydophila psittaci, Coxiella burnetii, Legionella pneumophila, Mycoplasma pneumoniae Matrix: Swab Copies/vial: 2,000 to 10,000 AMPLIRUN TOTAL FLU A/FLU B/RSV CONTROL (SWAB) Code: MBTC028 Analytes: Influenza A, influenza B, RSV Matrix: Swab Copies/vial: 2,000 to 10,000 AMPLIRUN TOTAL RESPIRATORY VIRAL PANEL CONTROL (SWAB) Code: MBTC020 Analytes: Adenovirus 4, coronavirus, influenza A H3N2, influenza B, novel influenza A H1N1, parainfluenza 1, parainfluenza 2, parainfluenza 3, RSV (subtype A), RSV (subtype B) Matrix: Swab 4 AMPLIRUN TOTAL
7 TUBERCULOSIS INFECTIONS AMPLIRUN TOTAL MDR-TB VERIFICATION & CONTROL PANEL (SPUTUM) Code: MBTC027 Analytes: 2 vials x Mycobacterium tuberculosis 2 vials x Mycobacterium tuberculosis RIF resistant rpob mutation (S531L) 2 vials x Mycobacterium tuberculosis RIF resistant rpob mutation (H526D) 2 vials x Mycobacterium tuberculosis INH RESISTANT katg mutation (S315T) 2 vials x Mycobacterium tuberculosis INH RESISTANT inha mutation (C15T) Matrix: Sputum Copies/vial: 20,000 to 50,000 (5x2) AMPLIRUN TOTAL MTB CONTROL (SPUTUM) Code: MBTC013 Analytes: Mycobacterium tuberculosis Matrix: Sputum Copies/vial: 20,000 to 50,000 AMPLIRUN TOTAL MTB INH RESISTANT CONTROL (SPUTUM) Code: MBTC015 Analytes: 5 vials x Mycobacterium tuberculosis katg mutation (S315T) 5 vials x Mycobacterium tuberculosis inha mutation (C15T) Matrix: Sputum Copies/vial: 20,000 to 50,000 (2x5) AMPLIRUN TOTAL MTB RIF RESISTANT CONTROL (SPUTUM) Code: MBTC014 Analytes: 5 vials x Mycobacterium tuberculosis rpob mutation (S531L) 5 vials x Mycobacterium tuberculosis rpob mutation (H526D) Matrix: Sputum Copies/vial: 20,000 to 50,000 (2x5) AMPLIRUN TOTAL 5
8 GASTROINTESTINAL INFECTIONS AMPLIRUN TOTAL CLOSTRIDIUM DIFFICILE CONTROL (STOOL)* Code: MBTC026 Analyte: Clostridium difficile RT027 Matrix: Stool Copies/vial: 10,000 to 25,000 Fill volume: AMPLIRUN TOTAL GASTROINTESTINAL BACTERIAL PANEL CONTROL (STOOL) Code: MBTC021 Analytes: Campylobacter jejuni, Clostridium difficile, Escherichia coli (EHEC), Salmonella enteritidis, Shigella flexneri, Yersinia enterocolitica Matrix: Stool Copies/vial: 10,000 to 25,000 Fill volume: MONONUCLEOSIS INFECTIONS AMPLIRUN TOTAL EBV CONTROL (PLASMA) Code: MBTC019 Analyte: Epstein-Barr virus (International Units - EBV B95-8 strain) Matrix: Plasma Fill volume: 6 AMPLIRUN TOTAL
9 SEXUALLY TRANSMITTED INFECTIONS AMPLIRUN TOTAL CT/NG CONTROL (EXUDATE) Code: MBTC006 Analytes: Chlamydia trachomatis, Neisseria gonorrhoeae Matrix: Exudate Copies/vial: 2,500 to 10,000 Copies/ml: 5,000 AMPLIRUN TOTAL CT/NG CONTROL (URINE) Code: MBTC003 Analytes: Chlamydia trachomatis, Neisseria gonorrhoeae Matrix: Urine Copies/vial: 2,500 to 10,000 Copies/ml: 5,000 AMPLIRUN TOTAL CT/NG/TV/MGE CONTROL (SWAB) Code: MBTC024 Analytes: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium Matrix: Swab Copies/vial: 20,000 to 50,000 AMPLIRUN TOTAL HSV-1/HSV-2/VZV CONTROL (EXUDATE) Code: MBTC016 Analytes: Herpes simplex virus & Varicella-zoster virus Matrix: Exudate AMPLIRUN TOTAL 7
10 TORCH INFECTIONS AMPLIRUN TOTAL CMV CONTROL (PLASMA) Code: MBTC018 Analytes: Cytomegalovirus (International Units - hcmv Merlin strain) Matrix: Plasma AMPLIRUN TOTAL HSV-1/HSV-2 CONTROL (CSF) Code: MBTC009 Analytes: Herpes simplex virus 1 & 2 Matrix: CSF AMPLIRUN TOTAL HSV-1/HSV-2 CONTROL (PLASMA) Code: MBTC012 Analytes: Herpes simplex virus 1 & 2 Matrix: Plasma VECTOR-BORNE INFECTIONS AMPLIRUN TOTAL ZIKV-DENV-CHIKV CONTROL (PLASMA) Code: MBTC023 Analytes: Zika virus, dengue virus (1-4), chikungunya virus Matrix: Plasma Fill volume: 8 AMPLIRUN TOTAL
11 Ordering Information Placing orders When ordering, please specify: Company name. Ship to and bill to address. Product catalogue number and description. Unit size and quantity. Special shipping conditions, if any. Free samples policy Samples are available free of charge for testing purposes. Please contact your Area Manager to ask for our sample request form. Order cancellation Requests for cancellation should be submitted one week in advance for cell culture products. For the rest of the product lines, three days advanced notice is required. Terms and Conditions Prices Product price shall be the prices specified in our current price list on the date of order. We reserve the right to revise our prices at any time with at least 1 month prior notice. Unless we state otherwise in writing, all prices are ex-works. The validity period for preorders/orders awaiting prepayment will be one month. After that time, order confirmation is required. Technical Support For technical assistance and product information, please visit our website or contact our Technical Service Department at customerservice@vircell.com We strive to answer all s within 24 hours, and most are answered in substantially less time.
12 RESPIRATORY INFECTIONS AMPLIRUN TOTAL ATYPICAL BACTERIAL PNEUMONIA CONTROL (SWAB) AMPLIRUN TOTAL FLU A/FLU B/RSV (SWAB) AMPLIRUN TOTAL RESPIRATORY VIRAL PANEL CONTROL (SWAB) MBTC022 MBTC028 MBTC020 MYCOBACTERIAL INFECTIONS AMPLIRUN TOTAL MDR-TB VERIFICATION & CONTROL PANEL (SPUTUM) AMPLIRUN TOTAL MTB CONTROL (SPUTUM) AMPLIRUN TOTAL MTB INH RESISTANT CONTROL (SPUTUM) AMPLIRUN TOTAL MTB RIF RESISTANT CONTROL (SPUTUM) MBTC027 MBTC013 MBTC015 MBTC014 GASTROINTESTINAL INFECTIONS AMPLIRUN TOTAL CLOSTRIDIUM DIFFICILE CONTROL (STOOL)* AMPLIRUN TOTAL GASTROINTESTINAL BACTERIAL PANEL CONTROL (STOOL) MBTC026 MBTC021 MONONUCLEOSIS INFECTIONS AMPLIRUN TOTAL EBV CONTROL (PLASMA) SEXUALLY TRANSMITTED INFECTIONS AMPLIRUN TOTAL CT/NG CONTROL (EXUDATE) AMPLIRUN TOTAL CT/NG CONTROL (URINE) AMPLIRUN TOTAL CT/NG/TV/MGE CONTROL (SWAB) AMPLIRUN TOTAL HSV-1/HSV-2/VZV CONTROL (EXUDATE) MBTC019 MBTC006 MBTC003 MBTC024 MBTC016 PME003-12/18 TORCH INFECTIONS AMPLIRUN TOTAL CMV CONTROL (PLASMA) AMPLIRUN TOTAL HSV-1/HSV-2 CONTROL (CSF) AMPLIRUN TOTAL HSV-1/HSV-2 CONTROL (PLASMA) MBTC018 MBTC009 MBTC012 VECTOR-BORNE INFECTIONS AMPLIRUN TOTAL ZIKV-DENV -CHIKV CONTROL (PLASMA) MBTC023 Parque Tecnológico de la Salud, Avicena Granada, Spain.
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