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8/9/2019 Amino Acid Analyzers http://slidepdf.com/reader/full/amino-acid-analyzers 1/17  5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA  Tel +1 (610) 825-6000  Fax +1 (610) 834-1275  Web www.ecri.org  E-mail [email protected] UMDNS Information This Product Comparison covers the following device term and product code as listed in ECRI Institute’s Universal Medical Device Nomenclature System™ (UMDNS™):   Analyzers, Laboratory, Body Fluid, Amino Acid [15-090] Amino Acid Analyzers  Scope of this Product Comparison This Product Comparison covers automated amino acid analyzers that can be used in the clinical laboratory. The major components are listed in the chart; however, several manufacturers make other configurations available. The two most commonly used high-performance liquid chromatography (HPLC) techniques for amino acid analysis, ion-exchange and reversed-phase liquid chromatography (LC), are discussed. (See the Product Comparison titled Chromatography Systems, Liquid, High-Performance for more information on the principles of HPLC.) Purpose Amino acid analyzers detect and quantify primary and secondary amino acids in physiologic fluids such as plasma and urine to confirm diagnoses and monitor treatment of inborn metabolism errors and of other disorders. These disorders are usually genetically produced errors in protein metabolism and can have serious complications if not detected and treated early. The most common of disorder is phenylketonuria (PKU), in which an enzyme deficiency results in increased concentrations of phenylalanine. PKU occurs an average of once in every 10,000 births and is associated with mental retardation, seizures, and eczema. Other aminoacidurias include tyrosinemia, alkaptonuria, homocystinuria, and branched-chain ketoaciduria (maple syrup urine disease), in which an enzyme defect in the decarboxylation of branched-chain α-keto acids increases concentrations of leucine, isoleucine, valine, and alloisoleucine. Changes in amino acid levels can also be caused by starvation, injury, sepsis, liver or renal failure, and cancer. Amino acid analyzers can also detect neurochemically active amino acids (aspartate, glutamate, and α- aminobutyric acid) in cerebrospinal fluid and can be used to assess the nutritional status of patients before surgery as well as to follow the progress of their treatment. Principles of operation Amino acids are organic compounds containing an amino group (NH2) and a carboxyl group (COOH), which are linked by peptide  bonds to form proteins. Many are synthesized by the body, while others are supplied in the diet. The important feature in separating amino acids is their basic structure: they are highly polar substances Comprehensive of Biomedical Engineering Site (www.dezmed.com   W   W   W  .   D   E   Z   M   E   D  .   C   O   M

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5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA  Tel +1 (610) 825-6000  Fax +1 (610) 834-1275  Web www.ecri.org  E-mail [email protected]

UMDNS Information

This Product Comparison covers the followingdevice term and product code as listed in ECRIInstitute’s Universal Medical Device NomenclatureSystem™ (UMDNS™): 

  Analyzers, Laboratory, Body Fluid, Amino Acid [15-090]

Amino Acid Analyzers

 

Scope of this Product Comparison

This Product Comparison covers automated amino acid analyzers that can be used in the clinical laboratory.

The major components are listed in the chart; however, several manufacturers make other configurations

available. The two most commonly used high-performance liquid chromatography (HPLC) techniques for amino

acid analysis, ion-exchange and reversed-phase liquid chromatography (LC), are discussed.

(See the Product Comparison titled Chromatography Systems, Liquid, High-Performance for more informationon the principles of HPLC.)

Purpose

Amino acid analyzers detect and quantify primary

and secondary amino acids in physiologic fluids such as

plasma and urine to confirm diagnoses and monitor

treatment of inborn metabolism errors and of other

disorders. These disorders are usually genetically

produced errors in protein metabolism and can have

serious complications if not detected and treated early.

The most common of disorder is phenylketonuria(PKU), in which an enzyme deficiency results in

increased concentrations of phenylalanine. PKU occurs

an average of once in every 10,000 births and is

associated with mental retardation, seizures, and eczema. Other aminoacidurias include tyrosinemia,

alkaptonuria, homocystinuria, and branched-chain ketoaciduria (maple syrup urine disease), in which an enzyme

defect in the decarboxylation of branched-chain α-keto acids increases concentrations of leucine, isoleucine,

valine, and alloisoleucine. Changes in amino acid levels can also be caused by starvation, injury, sepsis, liver or

renal failure, and cancer.

Amino acid analyzers can also detect neurochemically active amino acids (aspartate, glutamate, and α-

aminobutyric acid) in cerebrospinal fluid and can be used to assess the nutritional status of patients before

surgery as well as to follow the progress of their treatment.

Principles of operation

Amino acids are organic compounds containing an amino group

(NH2) and a carboxyl group (COOH), which are linked by peptide

 bonds to form proteins. Many are synthesized by the body, while

others are supplied in the diet. The important feature in separating

amino acids is their basic structure: they are highly polar substances

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Figure 2. Difference between α - and β- amino acids

and exist in aqueous solutions as dipolar ions called

zwitterions, which have both negatively and

positively charged groups. The amino acids’

functional group (R), as shown in Figure 1, is used to

distinguish one amino acid from another; the figure

illustrates amino acid separation. Primary, orα , aminoacids have the amine group attached to the α , or first,

carbon atom adjacent to the carboxyl group;

secondary, or ß, amino acids have the amine group

attached to the ß, or second, carbon atom (see Figure

2). Some analyzers separate only primary amino acids,

while others separate both primary and secondary

amino acids.

Before chromatographic analysis, the peptide bonds

are dissolved in a solvent, and the sample is typically

reacted with phenyl isothiocyanate in a buffer to form a phenylthiocarbamyl (PTC) derivative. The PTC amino

acids are converted to phenylthiohydantoin amino acid derivatives that are then separated by chromatography

and react with a reagent, such as ninhydrin, forming a colored compound.

Chromatography separates sample components based on differences in their relative affinities for different

media, which are divided into two phases: stationary and mobile. Automated amino acid analysis requires HPLC,

which uses a liquid mobile phase forced through a column by a high-pressure pump. Sample injection can be

automatic or manual. The column contains the stationary phase, which in HPLC is composed of a liquid bound to

a solid or a liquid through which the mobile phase percolates.

There are five basic HPLC techniques: adsorption, partition or bonded phase, reversed phase, ion exchange,

and size exclusion. Adsorption chromatography separates components by differences in solubility and binding

strength to the adsorbent. In partition-phase chromatography, the stationary and mobile phases are immiscible

liquids, and the components are separated according to their solubility ratios in the two phases. Reversed-phase

chromatography is similar to the partition technique, except that the polarities of the two liquids are reversed.

Ion-exchange chromatography uses ion-exchange resins for the stationary phase and a buffer solution as the

mobile phase. Size-exclusion chromatography uses a porous packing material that retains larger molecules while

allowing smaller ones to pass through, thereby separating components by molecular size.

The basic components of an HPLC system are a solvent reservoir, high-pressure pump, sample injector,

analytical column, detector, data recorder, and microprocessor. The solvent reservoir contains the mobile phase.

The pump, either single- or dual-piston reciprocating, contains a cam or gears that drive a piston into and out of

the pump. In the fill mode, the piston is withdrawn from the chamber, and liquid is drawn from the solvent

reservoir into the pumping chamber. In the pumping mode, the inlet check valve closes, and the outlet valve

opens as the piston drives the liquid into the column. A disadvantage of this type of pump is the pulsing nature

of the solvent flow; however, most systems

incorporate a damping mechanism that controls

this effect. The pumps in amino acid analyzersmost frequently use pressures from 1,000 to 3,000

pounds per square inch (psi).

The sample injector introduces the sample into

the column. The fixed-loop injector, the most

widely used type, is filled using a noncalibrated

syringe; the sample volume is dictated by the size

and internal diameter of the sample loop.

Figure 1. Basic structure of an amino acid

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Variable-volume injectors use a calibrated syringe to inject a precise volume into the loop.

The analytical column contains the stationary phase and is the most important part of the separation system.Usually composed of stainless steel that can withstand pressures up to 10,000 psi, the column ranges from 10 to

150 cm in length and from 2 to 5 mm in internal diameter. Column packing material should have minimum dead

volume (i.e., be tightly packed) and ensure maximum efficiency (i.e., narrow peaks on the chromatogram). Two

types of columns—the precolumn and the guard column—protect the analytical column. The precolumn is

located between the pump and the injection valve; in amino acid analysis, it separates derivatized amino acids.

The guard column, located between the injector and the analytical column, prolongs the life of the analytical

column by collecting any particulate matter or debris that would otherwise accumulate there. HPLC columns are

highly efficient when used with small (3, 5, or 10 μm), porous particles. Particle size must be as uniform as

possible for efficient columns and optimal operating pressures. Spherical and irregularly shaped particles are

available; columns packed with these seem to be more durable and can operate at lower pressures.

In ion-exchange LC, the stationary phase is an ion-exchange resin that separates compounds by the sign andmagnitude of their ionic charges. An aqueous solution is used as the mobile phase. The resins are highly

polymerized supports consisting of hydrocarbons with ionized functional groups. Available in the form of beads

or granular particles, they have an exchangeable counterion, which carries a charge opposite from that of the

functional group (i.e., cation exchangers contain acidic groups, and anion exchangers contain basic groups). The

sample cation (X+) of the cation exchange resin (often used for amino acids) competes with the mobile-phase ions

(Y+) for ionic sites on the support. Figure 3 shows how the counterions are replaced by sample cations and bind to

the functional groups. The neutral molecules and anions flow through the column and separate from the attached

sample cations. Another ion of higher affinity or large amounts of the same counterion can be used to elute the

Figure 3. The principle of ion-exchange resins

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sample cations, releasing the weakly bound cations first. This method also incorporates a postcolumn reaction of

ninhydrin with free amino acids, so the results can be detected in the visible range. Elution can also be adjusted

 by controlling the pH of the mobile phase, depending on the stationary phase and sample ion that are being used

in the column.

In reversed-phase LC, a derivatizing reagent is usually added to the sample before it enters the column. The

mobile phase is polar and the stationary phase is nonpolar, thereby allowing the amino acids to separate by theirpolar functional groups (amines), which in normal phase would adsorb too strongly to the silica. The nonpolar

packings are hydrocarbons chemically bound to a silica base, allowing the more polar compounds to separate

first. One type of packing is octadecyl (C18 hydrocarbon bonded to silica particles), referred to as ODS (octadecyl

silica). The polar mobile phase can consist of acetonitrile, aliphatic alcohols, water, tetrahydrofuran, or mixtures

of these solvents.

The detector quantifies compounds as they elute from the column by relying on changes in the bulk property

of the mobile phase and the sample constituents, such as the refractive index (color change), or on some

characteristic property of the sample constituent, such as fluorescence or ultraviolet absorption. The most widely

used detector is the fixed- or variable-wavelength ultraviolet-visible photometer, which can detect nanogram

quantities. Another detector, the fluorometer, has a high sensitivity for fluorescent compounds and can determine

picogram quantities.

Reported problems

Problems can occur when buffers are contaminated with microorganisms, mainly Pseudomonas species, that

exhibit dihydrolase activity for arginine and decarboxylase activity for ornithine and lysine. This contamination

can lead to a loss of arginine and can also affect other amino acid recoveries.

The storage of specimens for even 24 hours can alter the plasma amino acid levels; therefore, specimens should

 be analyzed as soon as possible. Because some derivatizing reagents are unstable, derivatized amino acids must

 be assayed rapidly, and repeat testing may not yield reproducible results. Inaccurate results can also be caused by

contamination from a previous sample when using fixed-loop valves. The valve must be flushed with 5 to 10 loop

volumes before loading.

The various standardization procedures have some limitations. External standardization is subject to variablesample losses— both during the preparative steps and before chromatography analysis—as well as sample

injection variability. Under normal conditions, the internal standard should not be present in the sample: the

difficulty involved in accurately measuring two peaks could limit precision.

The use of uncoated glassware in automated analyzers may pose a safety hazard to laboratory personnel

 because of the risk of breakage from solvent or buffer bottles. One reported case involved a borosilicate glass

 bottle in an amino acid analyzer that exploded. The agency that reported the incident, the Scottish Home and

Health Department, a branch of the U.K. Department of Health, also recommends that laboratories considering

the use of plastic-coated glassware check with the supplier to determine whether the glassware is suitable for its

intended applications, since different plastic coatings resist chemicals differently, have assorted properties at

varied temperatures and pressures, and have distinct aging properties.

Purchase considerations

ECRI Institute recommendations

The accompanying comparison chart includes ECRI Institute’s recommendations for minimum performance

requirements for amino acid analyzers. The specifications have been rated using three categories: Required,

Preferred, and Optional. A rating of Required indicates that this specification is the minimum necessary for the

analyzer to perform its indicated function. The Preferred rating is used for specifications that enhance either test

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operations or ease of use and, therefore, effectiveness. The Optional rating indicates a specification that does not

affect the analyzer performing its inherent function, but the presence of these options will provide wider

applications of use by offering greater testing options or minimizing user interaction, allowing the analyzer to be

effectively operated under a wide variety of circumstances.

Facilities purchasing amino acid analyzers should take into consideration the automated features of the

instrument. Certain automatic features are desirable to facilitate sample analysis. For example, automatic sampleinjection is preferred to manual injection. Automatic sample injection eliminates the possibility of operator error

and ensures that all samples are treated in the same manner. Automated flushing after sample analysis ensures

that the analyzer is properly prepared for each subsequent sample and that no crossover contamination will

interfere with readings. It is recommended that clinical laboratory analyzers be able to interface with a laboratory

information system (LIS) in order to more easily collect and report diagnostic test results. The analyzer should

also be capable of displaying results and other information both on a monitor and as a printout.

The sample column should be made with a rustproof material to ensure longevity of the column. The column

should generally have a length of 10 to 150 cm and a width of 2 to 5 mm. The particle size should be as uniform as

possible to ensure adequate separation of the sample. Dual-piston, single-piston, and syringe eluent pumps are all

generally acceptable. The pump should have a pressure limit of at least 2,000 psi.

Other considerations

Ideally, before making a purchase, facilities should evaluate the amino acid analyzers they are considering in

their own clinical environment for a few weeks. On-site evaluation enables laboratories to verify the

characteristics of the instrument reported by the manufacturer (e.g., pump flow accuracy, detector sensitivity and

stability) with the workload and sample types that the laboratory normally handles.

Because of the risk of infection involved with handling any body-fluid specimen, purchasers should consider

devices that minimize operator contact with specimens.

Final regulations of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) were published by the

U.S. Department of Health and Human Services in February 1992. Under the CLIA regulations, all clinical

laboratories are required to obtain federally issued certificates. To acquire a certificate, a lab must meet all

relevant standards, which are determined by the complexity of the tests being performed. The standards set forth by CLIA apply to areas such as patient test management, quality control (QC), proficiency testing, personnel

qualifications, and quality assurance (QA) programs. Certification fees vary according to complexity level and

test volume. There are different levels of complexity outlined in the CLIA regulations with corresponding

calibration and quality control requirements. These requirements have changed as of January 2003. More

information can be found at the following Web site: http://www.cms.gov/clia. 

Before purchasing new equipment or upgrading existing equipment, laboratories should thoroughly

investigate the CLIA regulations that apply to their facility and to the devices being considered. In certain

situations, purchasing or upgrading a device may change the complexity category of the procedures. This could

require additional staff training and certification, as well as changes in QC, proficiency testing, QA programs, and

other laboratory procedures.

An important consideration is the system’s computer interface capabilities. The effectiveness of the interfacewith the existing LIS or the hospital’s central computer system is crucial for inputting test data, verifying testing

accuracy, and maintaining QC, calibration, proficiency testing, and patient files according to CLIA guidelines.

Although CLIA does not mandate computerized reporting systems in hospital laboratories, it does require

laboratories to have a system in place to ensure compliance with CLIA performance standards for QC and QA of

patient testing instruments and procedures. An effective LIS interface is a fast and efficient way to manage the

large volume of test data that a laboratory generates each day as well as a convenient method of organizing and

storing data needed to comply with CLIA and other inspection agencies’ requirements. (See the Product

Comparison titled Information Systems, Laboratory for more information.)

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Cost containment

The following performance features can be used to assess an analyzer’s overall usefulness as well as its long -

term operating costs:

  Column resolution. The ability of an LC column to separate a sample into its component amino

acids, as determined by a given control. Poor column resolution leads to costly duplicate and

corroborative testing on other instruments or, if the broad error range is not recognized, may

cause incorrect patient diagnoses.

  Sample retention. The time it takes to process a sample in the chromatography column. Long

retention times lead to lengthy sample turnaround times, which can reduce long-term laboratory

productivity and revenue.

   Analytical range. The concentration range over which the detector can measure a particular amino

acid compound. Purchasers should check these values carefully under conditions in their own

laboratories because actual ranges may vary significantly from those stated by the manufacturer.

  Response/noise ratio. The ability of the instrument to distinguish between the signal of the amino

acid being analyzed and extraneous signals from other sources (e.g., column residue, interfering

compounds). Analyzers with low response/noise ratios produce inconclusive test results,

frequently requiring duplicate testing.  Specificity. The ability of the detector to measure only the compound selected. If an analyzer

cannot discriminate between a selected amino acid and another substance with similar

properties, it includes them both in the analyte measurement. Instruments that measure a

substance nonspecifically can provide results that may lead to a false diagnosis, requiring costly

verification on other instruments.

  Precision. A high degree of precision, which is a measure of how closely a test result can be

reproduced, not only provides a more sensitive determination of changes in the patient’s

condition but also reduces the need for much duplicate testing to verify the accuracy of initial test

results. Precision is expressed numerically in terms of the coefficient of variation (CV), with a

small CV indicating a highly precise instrument.

  Stability. Analyzers that give readings with a high degree of precision for extended periods of usehave very stable calibration curves. These units may be less costly to operate than analyzers with

more labile curves because they do not require recalibration as often; the unit thus uses fewer

calibration controls and runs fewer nonpatient analytical tests.

Onboard reagent stability is an important consideration because some reagents lose their efficacy a short time

after they are inserted into the analyzer. Reagents that must be discarded because they have lost their effective

strength or have been contaminated will increase testing costs.

  Carryover. The residue left over from a previous sample in a sample injector loop. This results

from incomplete flushing of the loop with a wash solution. Carryover can cause erroneously high

or low readings in samples and can result in duplicate testing or even unit shutdown if the

problem cannot be corrected by adjusting the washing cycle.  Downtime. The time during which the analyzer is undergoing routine maintenance or is shut

down for troubleshooting and repairs. A unit that requires frequent maintenance or has a poor

reliability record cannot consistently handle a normal workload and will cost the laboratory

money to service (even with a good service contract), as well as lose testing revenue. Under these

circumstances, a reliable backup analyzer is a necessity.

Buyers should try to obtain a written guarantee from the device supplier specifying the length of time the

device is likely to operate at normal usage before it will require servicing. The guarantee should contain financial

penalties against the supplier if the device fails beforehand or if it fails again prematurely after servicing.

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Current analyzer users are valuable sources of information on the quality, reliability, and overall efficiency of

the instruments. Buyers should ask manufacturers to supply an unedited list of their customers when considering

an instrument.

  Upgrading/interfacing. Potential purchasers should consider whether the analyzer can accept

future hardware upgrades and if the unit can interface with other laboratory instruments (e.g.,

chemistry analyzers) that can provide additional parameters. Included in an estimate of recurringexpenses should be the cost of upgrading the software annually.

  Flexibility. Some amino acid analyzers can be used for other applications, such as therapeutic

drug monitoring and assaying for vitamins, certain hormones, and physiologic indicators (e.g.,

creatinine). Instruments with this kind of flexibility have an increased value to the laboratory

 because of their wide range of uses as backup units to more dedicated instruments and as

alternative testing devices for running corroborative tests. They also help reduce the number of

workstations in the laboratory.

Hospitals should negotiate the best price for consumables (e.g., reagents, calibration gases, controls), training

programs, and service contracts at the time of purchase. They should also retain the option to accept or reject the

service contract at the end of the warranty period.

Stage of development

Technological advancements in HPLC have led to improved techniques in amino acid analysis and to a greater

variety of HPLC equipment, which, in turn, has enhanced market interest. Reversed-phase LC has become widely

accepted because it can reduce turnaround time without loss of sensitivity. In addition, some of the newer HPLC

derivatizing reagents can develop stable derivatives with amino acids. Online derivatization systems enhance

sensitivity and reduce manual input.

Advanced microprocessors have allowed the development of completely automated amino acid analysis

systems and have helped reduce turnaround time. Computer workstations allow automatic generation of

calibration curves from standards, automation of the chromatography system, rapid data input and test result

storage, and data communication with other computer systems in the laboratory and hospital. Analyzer

technology has become sufficiently versatile to adapt to batch analysis and is therefore useful in diagnosticapplications and for research.

Bibliography

Burtis CA, Ashwood ER, eds. Tietz fundamentals of clinical chemistry. 5th ed. Philadelphia: WB Saunders; 2001.

Centers for Disease Control and Prevention, Centers for Medicare & Medicaid Services. Medicare, Medicaid, and

CLIA programs; laboratory requirements relating to quality systems and certain personnel qualifications [final

rule]. Fed Regist 2003 Jan 24;68(16):3639-714.

Henry JB. Clinical diagnosis and management by laboratory methods. 20th ed. Philadelphia: WB Saunders; 2001.

Hersh LS, ed. New developments in clinical instrumentation. Boca Raton (FL): CRC Press; 1981.

Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement

Amendments of 1988 (CLIA)—HCFA [final rule with comment period]. Fed Regist 1992 Feb 28;57(40):7002-186.

Narayanan S. Principles and applications of laboratory instrumentation. Chicago: ASCP Press; 1989.

Schoeff LE, Williams RH, eds. Principles of laboratory instruments. St. Louis: Mosby-Year Book; 1993.

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Supplier information

BIOCHROM

Biochrom Ltd [391206]

22 Cambridge Science Park Milton Road

Cambridge CB4 4FJ

EnglandPhone: 44 (1223) 423723 Fax: 44 (1223) 420164

Internet: http://www.biochrom.co.uk 

E-mail: [email protected] 

GBC SCIENTIFIC

GBC Scientific Equipment Inc [108495]

151 N State St Suite A PO Box 339

Hampshire, IL 60140

Phone: (847) 683-9870, (866) 442-2724 Fax: (847) 683-9871

Internet: http://www.gbcsci.com 

E-mail: [email protected] 

GBC Scientific Equipment Pty Ltd [139347]

12 Monterey Road

Dandenong 3175

Australia

Phone: 61 (3) 92133666 Fax: 61 (3) 92133677

Internet: http://www.gbcsci.com 

E-mail: [email protected] 

HITACHI

Hitachi High-Technologies America Inc [409074]

10 N Martingale Suite 500

Schaumburg, IL 60173

Phone: (847) 273-4141 Fax: (847) 273-4407Internet: http://www.hitachi-hhta.com

E-mail: [email protected] 

Hitachi High-Technologies Europe (UK) [409777]

Craven House 40 Uxbridge Road Ealing

London W5 2BS

England

Phone: 44 (20) 73066727 Fax: 44 (20) 85665435

Internet: http://www.hht-eu.com

E-mail: [email protected] 

Hitachi High-Technologies Europe GmbH [409776]

Berliner Strasse 91

Ratingen D-40880

Germany

Phone: 49 (2102) 453156 Fax: 49 (2102) 436858

Internet: http://www.hht-eu.com 

E-mail: [email protected] 

Hitachi High-Technologies Corp [409075]

1-24-14 Nishi-Shimbashi Minato-ku

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Tokyo 105-8717

 Japan

Phone: 81 (3) 35047111 Fax: 81 (3) 35047123

Internet: http://www.hitachi-hitec.com 

E-mail: [email protected] 

JASCO

 JASCO Corp [137956]

2967-5 Ishikawa-cho Hachioji

Tokyo 192-8537

 Japan

Phone: 81 (426) 464111 Fax: 81 (4) 26464120

Internet: http://www.jasco.co.jp

E-mail: [email protected] 

 JASCO Eastern Europe Inf [418523]

Karolina utca 29-31

Budapest H-1113

Hungary

Phone: 36 (1) 4669579 Fax: 36 (1) 2093538Internet: http://www.jasco.co.jp 

E-mail: [email protected] 

 JASCO Europe srl [152763]

via Confalonieri 25

Cremella (LC) I-23894

Italy

Phone: 39 (039) 956439 Fax: 39 (039) 958642

Internet: http://www.jasco-europe.com 

E-mail:  [email protected] 

 JASCO Inc [102714]8649 Commerce Dr

Easton, MD 21601-9903

Phone: (410) 822-1220, (800) 333-5272 Fax: (410) 822-7526

Internet: http://www.jascoinc.com 

E-mail: [email protected] 

JEOL

 JEOL (Australasia) Pty Ltd [333604]

Unit 9 750-752 Pittwater Road

Brookvale 2100

Australia

Phone: 61 (2) 99058255 Fax: 61 (2) 99058286

Internet: http://www.jeol.com.au E-mail: [email protected] 

 JEOL (Europe) SA Poland [418633]

Oddziat w Warszawie ulica Szpitalna 1 pok 13

Warszawa PL-00-020

Poland

Phone: 48 (22) 8261252 Fax: 48 (22) 8261252

Internet: http://www.jeol.com 

E-mail: [email protected] 

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10 ©2007 ECRI Institute. All Rights Reserved.

 JEOL Ltd [140223]

Shin-Suzuharu Building 3/Fl 2-8-3 Akelbono-cho Tachikawa

Tokyo 190-0012

 Japan

Phone: 81 (4) 25283363 Fax: 81 (4) 25283386

Internet: http://www.jeol.com E-mail: [email protected] 

 JEOL USA Inc [105627]

11 Dearborn Rd

Peabody, MA 01960

Phone: (978) 535-5900 Fax: (978) 536-2205

Internet: http://www.jeol.com 

E-mail: [email protected] 

KNAUER

Wissenschaftliche Geraetebau Dr Ing Herbert Knauer GmbH [179828]

Hegauer Weg 38

Berlin D-14163Germany

Phone: 49 (30) 8097270 Fax: 49 (30) 8015010

Internet: http://www.knauer.net 

E-mail: [email protected] 

WATERS

Waters Corp [186647]

34 Maple St

Milford, MA 01757

Phone: (508) 478-2000, (800) 252-4752 Fax: (508) 872-1990

Internet: http://www.waters.com 

E-mail: [email protected] 

Note: The data in the charts derive from suppliers’ specifications and have not been verified through

independent testing by ECRI Institute or any other agency. Because test methods vary, different products’

specifications are not always comparable. Moreover, products and specifications are subject to frequent changes.

ECRI Institute is not responsible for the quality or validity of the information presented or for any adverse

consequences of acting on such information.

When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect supplier

discounts. And although we try to indicate which features and characteristics are standard and which are not,

some may be optional, at additional cost.

For those models whose prices were supplied to us in currencies other than U.S. dollars, we have also listed the

conversion to U.S. dollars to facilitate comparison among models. However, keep in mind that exchange rates changeoften.

Need to know more

For further information about the contents of this Product Comparison, contact the HPCS Hotline at +1 (610) 825-6000, ext.

5265; +1 (610) 834-1275 (fax); or [email protected] (e-mail).

Last updated October 2007

Comprehensive of Biomedical Engineering Site (www.dezmed.com

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©2007 ECRI Institute. All Rights Reserved 11

Policy Statement

The Healthcare Product Comparison System (HPCS) is published by ECRI Institute, a nonprofit organization.

HPCS provides comprehensive information to help healthcare professionals select and purchase diagnostic and

therapeutic capital equipment more effectively in support of improved patient care.

The information in Product Comparisons comes from a number of sources: medical and biomedical

engineering literature, correspondence and discussion with manufacturers and distributors, specifications from

product literature, and ECRI Institute’s Problem Reporting System. While these data are reviewed by qualified

health professionals, they have not been tested by ECRI Institute’s clinical and engineering personnel and are

largely unconfirmed. The Healthcare Product Comparison System and ECRI Institute are not responsible for the

quality or validity of information derived from outside sources or for any adverse consequences of acting on such

information.

The appearance or listing of any item, or the use of a photograph thereof, in the Healthcare Product Comparison

System does not constitute the endorsement or approval of the product’s quality, performance, or value,  or of

claims made for it by the manufacturer. The information and photographs published in Product Comparisons

appear at no charge to manufacturers.

Many of the words or model descriptions appearing in the Healthcare Product Comparison System are

proprietary names (e.g., trademarks), even though no reference to this fact may be made. The appearance of any

name without designation as proprietary should not be regarded as a representation that is not the subject of

proprietary rights.

ECRI Institute respects and is impartial to all ethical medical device companies and practices. The Healthcare

Product Comparison System accepts no advertising and has no obligations to any commercial interests. ECRI

Institute and its employees accept no royalties, gifts, finder’s fees, or commissions from the medical device

industry, nor do they own stock in medical device companies. Employees engage in no private consulting work

for the medical device industry.

About ECRI Institute

ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research

in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 40

years, ECRI Institute marries experience and independence with the objectivity of evidence-based research.

More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety

improvement, risk and quality management, healthcare processes, devices, procedures, and drug technology.

ECRI Institute is one of only a handful of organizations designated as both a Collaborating Center of the World

Health Organization and an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and

Quality. For more information, visit http://www.ecri.org. 

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12 ©2007 ECRI Institute. All Rights Reserved.

Product Comparison Chart

MODEL ECRI INSTITUTE'SRECOMMENDEDSPECIFICATIONS1 

BIOCHROM GBC SCIENTIFIC HITACHI

 Amino Acid Analyzers Biochrom 30 Aminomate L-8800 A

WHERE MARKETED Worldwide Worldwide WorldwideFDA CLEARANCE Yes Yes NoCE MARK (MDD) Yes Yes YesPERFORMANCE

Type of reaction Postcolumn ninhydrin Precolumn FMOC Postcolumn NINAmino acids detected Primary, secondary Primary, secondary, imino Primary, secondary Depends on analysis, amino

sugars with special columnNo. of components Not specified 35+ Depends on analysisAnalysis time, min Sample dependent 30 20-150, varies

SAMPLE INJECTORModel Midas LC 1650 Built-inType (fixed or variableloop)

Variable Variable Variable

Manual or automatic  Automatic, preferred Automatic Automatic AutomaticSample type Plasma, urine (preferred) Protein hydrolysate,

physiologic fluidsProtein, peptide,hydrolysates, feedhydrolysates, serum,plasma, IV fluids, beers,wines, juices

Protein hydrolysates,physiologic fluids

Sample volume, µL 1-5,000 1-200 0.1-100Sample capacity 84 160 200 1.5mL vialsVial size 100 µL, 200 µL; 2 mL 2 mL, 4 mL 1.5 mLAutoflushing Preferred User definable Optional Yes

DERIVATIZING REAGENT Ninhydrin FMOC NinhydrinOnline/manual Online (preferred) Online Online Online

COLUMNModel or variations Biochrom ODS-hypersoil Protein hydrolysate,

physiologic fluidsConstruction Rust-free material Polyetheretherketone

(PEEK), aluminumStainless steel Stainless steel

Length, cm/internaldiameter, mm

10-150/2-5 200/4.6, 100/4.6 15/4.6 Multiple available

Particle size, µm Uniform Not specified 5 3

Sorbent type Not specified Not specified Ion exchangeELUENT PUMP

Model Biochrom LC 1150 Built-inPump type Dual or single piston,

syringeDual piston Dual piston Dual piston

No. of pumps  At least 1 2 1 2Flow range, mL/min 0.08-2.16 0-9.99 0.001-9.999Increment of flowsetting, mL/min

0.016 0.01 0.001

Flow precision, % 0.1 0.1 .075Flow accuracy, % 0.5 0.1 2Pressure limit, psi ≥2,000  2,160 6,000 5600Gradient (continuous ormultistep)

Multistep Continuous Selectable

No. of eluents 6 4 4

This is the first of two pagescovering the abovemodel(s). Thesespecifications continue ontothe next page.

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Product Comparison Chart

MODEL ECRI INSTITUTE'SRECOMMENDEDSPECIFICATIONS1 

BIOCHROM GBC SCIENTIFIC HITACHI

 Amino Acid Analyzers Biochrom 30 Aminomate L-8800 ADATA REDUCTION

Model LIS computer interface(optional)

Biosys EZChrom Elite EZChrom Elite

No. of channels 2 Multiple 2Display Monitor, printer Color monitor Color monitor Color monitorChromatograms, no.stored

Hard drive/networkdependent

80 GB hard drive, 4bytes/data point

Infinite with read, CD-RW

DETECTORModel Biochrom LC 1255s Built-inType Vis Fluorescence UV/Vis, optional

fluorescenceFilter/grating Filter Grating GratingReference wavelength,nm

NA Not specified 656.1

Available wavelengths,

nm

440-570 200-600, optional 900 440, 570 fixed

Light source Tungsten DC arc xenon DeuteriumDrift, AU/hr <0.001 Not specified <0.001Noise, AUFS <0.001 Not specified <0.001Cell volume, µL 8 12, optional 2 3.2Cell pathlength, mm 15 Not specified Not specifiedAvailable absorbancerange, AUFS

Not specified Not specified 0.001-2.2

Autozero Yes Yes YesOthers available Fluorescence UV/Vis, electrochemical,

conductivity, RI, PDAFluorescence

POWER REQUIREMENTS 115/220 V, 50/60 Hz 240, 220, 115 V, 50/60 Hz 115 V, 50/60 HzLIST PRICE $100,000 Not specified $76,000

 YEAR FIRST SOLD 1969 1995 2005NUMBER OF UNITS SOLD >1,000 >400 Not specifiedFISCAL YEAR Not specified July to June April to March

OTHER SPECIFICATIONS None specified. IBM compatible; titaniumcorrosion-resistant path. Linear or step gradientsavailable; built-in automaticwash function; 3 pmoldetection using ninhydrin;postcolumn reaction columnminimizes peak diffusion;Windows 2000/XP operatingsystem.

LAST UPDATED October 2007 September 2006 September 2006Supplier Footnotes 1These recommendations

are the opinions of ECRIInstitute's technologyexperts. ECRI Instituteassumes no liability fordecisions made based onthis data.

Model Footnotes

Data Footnotes

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Product Comparison Chart

MODEL JASCO JEOL KNAUER WATERSOPA Amino Acid AnalysisSystem

 AminoTac JLC-500/V Smartline Amino Acid Analyzer A0426 : A0515

MassTrak Amino Acid Analysis Solution

WHERE MARKETED Not specified Asia, Europe Worldwide WorldwideFDA CLEARANCE Not specified No Not specified Not specifiedCE MARK (MDD) Yes Yes Yes YesPERFORMANCE

Type of reaction Pre-/postcolumnderivatization

Ninhydrin Precolumn OPA or FMOC Precolumn AQC

Amino acids detected Primary and secondary Primary and secondary Primary (and secondarywith FMOC)

Primary and secondary

No. of components Not specified ≤46  ≤20  42Analysis time, min Not specified 30 (protein hydrolyzed) or

120 (physiologic fluid)30 32

SAMPLE INJECTORModel  AS-2059 Built-in (JEOL) Spark Triathlon autosampler ACQUITY SMType (fixed or variableloop)

Selectable Variable Variable Variable

Manual or automatic  Automatic Automatic Automatic Automatic

Sample type Protein hydrolysates,physiologic fluids

Protein hydrolysates, freeamino acids (plasma, urine)

Protein hydrolysates,feedstuffs, physiologicfluids, others

Urine and plasma

Sample volume, µL Variable mode standard 0.1-200 µL, optional 1-2,000 µL

1-200 35-10,000 0.5-1

Sample capacity 120, optional 224 96 96 96Vial size 2 mL, optional 0.6 and 0.3

mL180 µL, 1.6 mL 1.8, 4, 10 mL 0.9 mL

Autoflushing Yes Yes Yes YesDERIVATIZING REAGENT OPA/ninhydrin Ninhydrin OPA or FMOC Not specified

Online/manual Online Online Online ManualCOLUMN

Model or variations  AA pack Na+ Cation exchanger Knauer column forprecolumn OPA or FMOC

Mass Trak AAA

Construction Stainless steel Stainless steel Stainless steel Stainless steelLength, cm/internaldiameter, mm

6/10 4/4, 3- or 4-segment 300/4 : 250/4.6 15/2.1

Particle size, µm 5 4 5 : 4 1.7Sorbent type Cation-exchanged resin Polymeric ion exchange ODS2 C18 : ODS2 C8 C-18

ELUENT PUMPModel PU-2089 Built-in (JEOL) Knauer Smartline 1000 ACQUITY BSMPump type Double-plunger/SSQD

methodFlow-sensor feedback,single piston

Dual piston, stainless steel 2 independently driven,software-controlled pistons

No. of pumps 1 2 1 2Flow range, mL/min 0.001-10 0.001-1 0.001-9.999 0.01-2Increment of flowsetting, mL/min

0.001 0.001 0.001 0.001

Flow precision, % ≤1  <1 0.1 0.15Flow accuracy, % 1% or 2 µL/min <1 0.5 1Pressure limit, psi 7,250 0.1 MPa/min 5,000 5,800 15,000Gradient (continuous ormultistep)

Continuous Multistep Continuous Continuous

No. of eluents 4 Up to 5 Up to 4 4

This is the first of two pagescovering the abovemodel(s). Thesespecifications continue ontothe next page.

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Product Comparison Chart

MODEL JASCO JEOL KNAUER WATERSOPA Amino Acid AnalysisSystem

 AminoTac JLC-500/V Smartline Amino Acid Analyzer A0426 : A0515

MassTrak Amino Acid Analysis Solution

DATA REDUCTIONModel JASCO Borwin/HSS2000

workstationWindows 95 ChromGate or ClarityChrom

softwareEmpower 2

No. of channels 2 2 4 Not specifiedDisplay CRT Color monitor TFT monitor Color monitorChromatograms, no.stored

Not specified Depends on disk size Depends on disk size Not specified

DETECTORModel FP-2020 Built-in (JEOL) Shimadzu RF-10AXL ACQUITY TUVType Fluorescence Visible Fluorescence UV/visibleFilter/grating Grating Grating Not specified GratingReference wavelength,nm

Zero order, 220-900 690 330 Not specified

Available wavelengths,nm

Zero order, 220-700 440, 570 200-650 190-700

Light source 150 W xenon lamp Halogen Xenon Deuterium arc lamp

Drift, AU/hr Not specified Not specified Not specified <5.0 x 10-4Noise, AUFS SNR >350 for Raman peak

of waterNot specified Not specified 6 x 10-6 AU

Cell volume, µL 16 2 12 0.5Cell pathlength, mm Not specified 3 Not specified 10Available absorbancerange, AUFS

Not specified 0.0001-2 Not specified 0.00001-4

Autozero Yes Yes Yes YesOthers available None specified Fluorescence detector Knauer Smartline PDA

Detector 2800None specified

POWER REQUIREMENTS 100-240 V 100-230 V, 50/60 Hz 90-260 V, 50/60 Hz Not specifiedLIST PRICE Not specified Not specified $55,000 : $60,000 $95,000

 YEAR FIRST SOLD Not specified 1985 1987 2008NUMBER OF UNITS SOLD Not specified 195 Not specified Not specifiedFISCAL YEAR September to August April to March Not specified January to DecemberOTHER SPECIFICATIONS None specified. Fully automated walkaway

system; 10 customer-madeanalysis methods; safetyaids; measure of amino acidresidue. Meetsrequirements of GLP.

For precolumn

derivatization; automatedreagent preparation withTriathlon autosampler.Meets requirements of GLPand TUV.

Includes standards,

reagents, vials, column, andmobile phases with pre-defined analysis andreporting methods;documentation installation,training and support arealso provided.

LAST UPDATED October 2007 October 2007 October 2007 October 2007Supplier Footnotes

Model Footnotes

Data Footnotes

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Product Comparison Chart

MODEL WATERSUPLC Amino Acid AnalysisSolution

WHERE MARKETED WorldwideFDA CLEARANCE Not specifiedCE MARK (MDD) YesPERFORMANCE

Type of reaction Precolumn AQCAmino acids detected Primary and secondaryNo. of components 32Analysis time, min 8.5

SAMPLE INJECTORModel  ACQUITY SMType (fixed or variableloop)

Variable

Manual or automatic  AutomaticSample type Protein hydrolysates, culture

media, fermentation broth,feed/food hydrolysates

Sample volume, µL 0.5-1Sample capacity 96Vial size 0.9 mLAutoflushing Yes

DERIVATIZING REAGENT  AccQ-FluorOnline/manual Manual

COLUMNModel or variations  AccQ-Tag UltraConstruction Stainless steelLength, cm/internaldiameter, mm

10/2.1

Particle size, µm 1.7Sorbent type C-18

ELUENT PUMPModel  ACQUITY BSMPump type 2 independently driven,

software-controlled pistonsNo. of pumps 2Flow range, mL/min 0.01-2Increment of flowsetting, mL/min

0.001

Flow precision, % 0.15Flow accuracy, % 1Pressure limit, psi 15,000Gradient (continuous ormultistep)

Continuous

No. of eluents 4

This is the first of two pagescovering the abovemodel(s). These

specifications continue ontothe next page.

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Product Comparison Chart

MODEL WATERSUPLC Amino Acid AnalysisSolution

DATA REDUCTIONModel Empower 2No. of channels Not specifiedDisplay Color monitorChromatograms, no.stored

Not specified

DETECTORModel  ACQUITY TUVType UV/visibleFilter/grating GratingReference wavelength,nm

Not specified

Available wavelengths,nm

190-700

Light source Deuterium arc lampDrift, AU/hr <5.0 x 10-4

Noise, AUFS 6 x 10-6 AUCell volume, µL 0.5Cell pathlength, mm 10Available absorbancerange, AUFS

0.00001-4

Autozero YesOthers available Photodiode and

fluorescencePOWER REQUIREMENTS Not specifiedLIST PRICE $79,500

 YEAR FIRST SOLD 2006NUMBER OF UNITS SOLD Not specifiedFISCAL YEAR January to DecemberOTHER SPECIFICATIONS Includes comprehensive

chemistry package, methoddocumentation, installation

and training. Specificallytested for AAA analysis.Validation, compliance, andquality programs available.

LAST UPDATED October 2007Supplier Footnotes

Model Footnotes

Data Footnotes

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