Naval Submarine Medical Research Laboratory

NSMRL REPORT 1191 2 FEBRUARY 1994

EVALUATION OF FIELD CONICAL LABORATORY EQUIPMENT FOR

FLEET MARINE SERVICES

P. L. Perrotta

C. Bolecek-Skeggs

E. M. Christ

D. W. Hobson

Released by:

P. K. Weathersby, CAPT, MSC, USN

Commanding Officer

Naval Submarine Medical Research Laboratory

20031216 195

Approved for public release; distribution unlimited
Evaluation of Field Clinical Laboratory Equipment for Fleet

Marine Service

P. L. Perrotta

C. Bolecek-Skeggs

E. M. Christ

D. W. Hobson

Naval Submarine Medical Research Laboratory

Report 1191

Naval Medical Research and Development Command

Research Work Unit 63706N M000095.005-5102

Approved and Released by

P.K. Weathersby, CAPT, MSC, USN

Commanding Officer

NAVSUBMEDRSCHLAB

Approved for public release; distribution unlimited
Summary Page

Problem:

The Medical Company of the Marine Corps Service Support Group

is tasked with the evaluation and procurement of clinical

laboratory equipment for field-use. Capabilities are required in

several broad areas which include testing of hematological,

chemical and blood gas parameters. Instruments intended for

hospital or clinic use are not designed to withstand the rugged

conditions encountered during military operations. The goal of

this project was to first identify and then test a variety of

commercially available laboratory instruments under severe

environmental and operational conditions.

Methods:

Clinical laboratory analyzers satisfying testing requirements

were identified and purchased. These instruments were evaluated

under each of the following conditions: ambient temperature range

(40OF to HQOF), combined heat/humidity, extreme storage

temperatures (-6OOF and I6OOF), simulated transport (vibration,

drop testing), altitude (8500 ft), salt/fog and sand/dust

operation.

Findings:

No single analyzer was capable of performing all of the

laboratory tests required by the Marine Corps Therefore, units

were evaluated within major diagnostic groups (e.g., hematology,

chemistry, coagulation, etc.). Results of operational testing are

presented for each of these classes of analyzers. Within a group

there are no absolute "winners" or "losers", but comparative data

is presented. In addition to these findings, the final decision on

which specific units to procure must also be based on other

considerations such as size, storage requirements, ease of use and

cost.

Application:

Information presented in this report will be used by Marine

Corps personnel involved with providing clinical laboratory

equipment to operational forces.

Administrative Information

This work was completed under Naval Medical Research

Development Command Research Work Unit 63706N-M000095.005-5102,

Evaluation of Field Clinical Laboratory Equipment for Fleet Marine

Service. The views expressed in this report are those of the

authors and do not reflect the official policy or position of the

Department of the Navy, Department of Defense, or the U.S.

Government. This report was approved for publication on 2 Feb 1994

and designated NSMRL Report 1191.

2
Abstract

We evaluated clinical laboratory equipment being considered

for purchase by the U.S. Marine Corps. This equipment will

provide clinicians with rapid access to laboratory data during

deployments. Capabilities were desired in the following areas:

hematology, chemistry, coagulation, blood gas analysis and

urinalysis. There is concern that severe conditions encountered

in the field may affect machine performance.

Analyzers were evaluated under each of the following

conditions: ambient temperature range (400F to 110°F), combined

heat/humidity, extreme storage temperatures (-60OF and ISOOp),

simulated transport (vibration, drop testing), altitude (8500

ft), salt/fog and sand/dust operation. Results are presented

separately for each class of analyzer. No singular "winner" or

"looser" stood out in any category. In general, instruments had

difficulty with warm and cold temperature operation.

This information can be used by Marine Corps personnel

involved with providing clinical laboratory equipment to

operational forces. Other factors which should be considered

include instrument size, storage requirements, ease of use and

cost.
Table of Contents

Summary Page 2

Abstract 3

Table of Contents 4

List of Tables 5

Introduction 6

Study Design and Methods 7

Results 14

Blood Gas Analyzers 16

Coagulation Analyzers 24

Hematology Analyzers 31

Chemistry Analyzers 3g

Electrolyte Analyzers 47

Urinalysis Analyzer 53

Discussion 59

References 61

List of Abbreviations 62

Appendix A -

Appendix B -

Appendix C -

Appendix D -

Laboratory Technician's Technical Profiles

Names and Manufacturers of Instruments Tested

Reference Ranges for Control Reagents

Results of Categorical Variable Analysis for

Urinalysis Analyzer
List of Tables

Blood Gas Analyzers

1. General Information 18

2. Summary of Test Offered and Costs 19

3. Comparison with Reference Analyzer 20

4. Temperature Condition Testing 21

5. Repeat Temperature Condition Testing 22

6. Transportation and Other Condition Testing .... 23

Coagulation Analyzers

7. General Information 26

8. Summary of Test Offered and Costs 27

9. Comparison with Reference Analyzer 28

10. Temperature Condition Testing 29

11. Transportation and Other Condition Testing .... 30

Hematology Analyzers

12. General Information 33

13. Summary of Test Offered and Costs 34

14. Comparison with Reference Analyzer 35

15. Temperature Condition Testing 36

16. Transportation and Other Condition Testing .... 37

Chemistry Analyzers

17. General Information 40

18. Summary of Costs 41

19. Summary of Test Offered 42

20. Comparison with Reference Analyzer 44

21. Temperature Condition Testing 45

22. Transportation and Other Condition Testing .... 46

Electrolyte Analyzers

23. General Information 48

24. Summary of Test Offered and Costs . 49

25. Comparison with Reference Analyzer 50

26. Temperature Condition Testing 51

27. Transportation and Other Condition Testing .... 52

Urinalysis Analyzer

28. General Information ....... 54

29. Summary of Test Offered and Costs 55

30. Comparison with Reference Analyzer 56

31. Temperature Condition Testing 57

32. Transportation and Other Condition Testing .... 58
Introduction

The Medical Company of the Marine Corps Field Service

Support Group provides medical support for military and

humanitarian missions. Clinical chemistry equipment can improve

the quality of medical care during these deployments by providing

clinicians with rapid access to laboratory data. This

information facilitates diagnostic and therapeutic decision

making for combat related injuries and non-combat illnesses.

Ideally, testing would include capabilities in the following

areas: hematology, chemistry, urinalysis, arterial blood gas

analysis and blood banking procedures.

Most clinical laboratory instruments available on the

Authorized Medical Allowance List (AMAL) have several

limitations. Many of the analyzers are large and heavy.

Reagents used by certain units require large amounts of storage

space, space which may need to be refrigerated. Several units

are not fully automated. Because military medical technicians

have various levels of experience, lack of automation could

increase the possibility of operator error.

The reliability of laboratory instruments could be adversely

affected by severe environmental conditions encountered during

use by the Marine Corps. Machines must survive minor impact and

vibration encountered during transportation. Generally,

temperature controlled storage space is not available. Once in

the field, analyzers must provide results that would be

clinically useful. Clinical laboratory instruments have not been

tested under these type of conditions.

Marine Corps medical personnel are now investigating the

operational use of clinical laboratory equipment. The

requirement was first specified by the Commanding General, Marine

Corps Research, Development, and Acquisition Command (1). This

tasking emphasized the importance of identifying equipment which

would meet the testing needs of the Marine Corps and then

evaluating these alternatives under realistic field conditions.

The primary objective of this project was to evaluate the

performance of currently available clinical laboratory equipment

operating under a variety of environmental and operational

conditions. Military laboratory technicians also assessed the

subjective aspects of instrument use. In addition to performance

characteristics, purchasing officials must also consider cost

(e.g., cost per analyzer, cost per test). Previous procurement

decisions have not included objective information on the

performance of equipment under realistic field use scenarios.
study Design and Methods

This study was conducted in four phases:

Phase 1: Identification and Procurement of Instruments

The Marine Corps required that instruments selected for

evaluation be commercially available. Therefore, no items under

development were considered. Instruments were to be capable of

performing one or more of the following tests (1):

1. Blood glucose (GLU)

2. Blood urea nitrogen (BUN)

3. Blood gasses (pC02, p02 and pH)

4. Sodium (NA)

5. Potassium (K)

6. Chloride (CL)

7. Carbon dioxide (CO2)

8. Hematocrit (HCT)

9. Hemoglobin (HGB)

10. Greatinine (CR)

11. Red blood cell count (RBC)

12. White blood cell count (WBC)

13. Routine and microscopic urinary analysis (UA)

14. Typing and crossmatching of whole blood (TCB)

15. Ova and parasite analysis (OPA)

16. Gram stain evaluations (GSE)

17. Rapid plasma reagin (RPR) determinations

A primary survey of Federal supply schedules identified

potential instruments. A secondary survey found additional items

not under Federal contracts. This involved reviewing commercial

literature, interacting with manufacturer representatives and

attending trade shows. At the conclusion of these surveys,

product literature was solicited from approximately 125 vendors.

This information included technical specifications and contract

information and was reviewed by a committee of medical and

technical personnel. The committee was composed of individuals

with the following expertise:

- Scientist/Investigator (Ph.D., Biomedical Engineering)

- Physician (Military)

- Cardio-Pulmonary Technician (Military)

- 4 Advanced Laboratory Technicians (Military)

- Civilian Laboratory Technician (prior Active Duty service)
General guidelines were followed during the initial

evaluation of the product literature. Smaller and lighter

analyzers were favored over heavier items. Automatically

calibrating units were preferable as were those whose reagents

required less storage space. The committee reviewed the product

information focusing on the following characteristics:

1. Weight

2. Size/Dimensions

3. Analyzer methodology

4. Calibration (automatic, semi-automatic, manual)

5. Type of reagents (cartridges, liquid, gas)

6. Tests performed by each analyzer

7. Cost per analyzer and cost per test

After evaluating the product literature, the committee

observed instrument demonstrations at the Naval Submarine Medical

Research Laboratory (NSMRL). Based on this initial survey, the

committee selected instruments which were procured for analytical

and operational performance evaluations in later phases of the

study.

Phase 2: Baseline Analytical Performance Evaluation

Instruments selected in Phase 1 were procured, set up and

calibrated using the manufacturer's recommended calibration

standards. Once calibrated, baseline data were collected from

commercially prepared blood or urine controls having known

results at levels considered "normal" or "abnormal." These

reference ranges were specified by the manufacturer of the

controls. For each analyzer, an effort was made to collect data

from ten samples of each control level each day for ten days (100

total samples per control level). The data was retained for

later comparison with data obtained during operational testing.

After collecting baseline control data approximately 100

human blood and urine samples were collected and analyzed by the

test instruments. Aliquots of these samples were submitted to

Naval Hospital Clinical Pathology laboratories at either Groton,

CT (NAVHOSP Groton) or Bethesda, MD (NNMC) to obtain laboratory

reference values for each parameter measured. Specifically, the

reference laboratory instrumentation consisted of the following:

Blood Gasesz

Arterial parameters on CIBA 178, 280 @ NNMC

Venous parameters on CIBA 280 @ NAVHOSP Groton
Coagulatiom

Ortho Diagnostics Coagulab 16S @ NAVHOSP Groton

Hematology:

Technicon Hi @ NAVHOSP Groton

Electrolytes and Clinical Chemistries'.

Baxter Paramax 720 @ NAVHOSP Groton

Urinalysis:

Manual dipsticks @ NAVHOSP Groton

Data sets were arranged in files by general instrument type

(e.g., clinical chemistry, electrolyte, hematology, etc.) using

computer spreadsheets. Each human sample record contained a

sample number, instrument identifier and data for each parameter

measured. Results of human sample testing were compared to

identify statistically significant differences in values obtained

by the test instrument and the reference analyzer. Following an

initial one-way analysis of variance (ANOVA) on the contrasting

data sets, multiple comparisons were performed using Tukey's

procedure (2). Statistically significant differences (P<0.05)

were reviewed by medical personnel to determine if they were

"clinically" significant. Clinically significant differences are

those that could result in errors in diagnosis or treatment of an

injury or illness. Statistics were performed on a VAX Computer

System running the SAS System, Release 6.07.

Phase 3: Operational Performance Evaluation

Each instrument was tested under a variety of environmental

conditions specified by the Marine Corps and in accordance with

military standards (3). Additional input was provided by

Commander, Marine Corps Systems Command (4). These conditions

were divided into the following categories:

Temperature Condition Testing;

- Cold Operation (400F, SO^F, SO^F)

- Warm Operation (llO^F, lOO^F, 900F)

- Combined Heat and Humidity (90-100OF/90% relative

humidity)
- Cold Storage (-6OOF)

- Warm Storage (I6OOF)

Transport and other Condition Testing;

- Simulated transport

Vibration (High Frequency Exposure)

Loose Cargo Test (Low Frequency Exposure)

Drop Testing

- Post-Altitude Operation (8,500 feet)

- Salty and Foggy environment (combined)

- Sandy and Dusty environment (combined)

Most of the environmental testing was performed at Fort

Detrick, Maryland in collaboration with their technical staff.

Several of the storage tests were performed at NSMRL. Detailed

descriptions of the test procedures follows:

Cold Operation

Analyzers were placed in an environmental chamber where the

ambient temperature was controlled at 40, 50, or eO^F. After the

unit equilibrated with ambient temperature it was operated in

accordance with manufacturer's specifications. Initial chamber

temperature was 40OF. If the unit did not function at 40OF the

chamber temperature was raised in 10 degree increments and the

test was repeated.

Warm Operation

This test was conducted as described under "Cold Operation"

except that the initial chamber temperature was llO^F. Ambient

temperature was decreased in 10 degree increments if the analyzer

was non-operational.

Combined Heat and Humidity

Analyzers were placed in an environmental chamber with a

relative humidity (RH) of 90 percent. Temperature was controlled

at 90, 100 or llO^F depending on the results of warm operation

testing. If a machine would not operate at llO^F but functioned

at lOO^F, the initial chamber temperature would be set at lOO^F.

If the unit did not operate the temperature was decreased in 10

degree increments and the test was repeated.

Cold and Warm Storage

In separate tests, units were placed in a chamber with

10
temperature controlled at either -60OF or I6OOF. After 6 hours

of storage the units were removed from the chamber and allowed to

return to normal ambient temperature (75-85°F). Machines were

tested after they were inspected for evidence of damage.

Simulated Transportation Testing

The goal of this test was to determine the ability of

analyzers to withstand vibration and shock during shipment and

deployment. The transportation test consisted of three portions

which were conducted in the following sequence: 1. High FrequencyVibration 2. Loose Cargo Vibration 3. Drop Test. Aftercompleting the Drop Test, the unit was tested for reliability.

Details of each of these tests follows:

High Frequency Vibration: Analyzers were packaged and

secured to a high frequency slip table. Packaging consisted

of 2 inches of 2-pound density foam inside either a steel

medical chest or a hard plastic shipping container. The

table produced a vibration profile that could occur in

common carriers, two-wheeled trailers and composite wheeled

vehicles. The vibration exposure lasted 30 minutes. The

units were then removed from the packing and inspected for

damage.

Loose Cargo Vibration: In the same packing

configuration described above, analyzers were placed on a

LAB Package tester. This test is designed to simulate

transport in a truck crossing rough terrain. The tester was

operated at 250-300 RPM for 45 minutes. Following the test,

units were inspected for loose parts and damage.

Drop (Shock) Test: Each analyzer was dropped a

vertical distance of 48 inches on to a 2 inch thick fir

platform backed by a concrete floor. Packing was that used

in the vibration testing. The units were dropped 5 times in

any combination of the bottom, 2 sides, 2 ends and the top

of the shipping container. The analyzer was then removed

from the packing and inspected for damage. Following

completion of the drop test, the unit was turned on and

tested with control solutions to access reliability after

simulated transport.

Post-Altitude Operation

While in the operating mode units were placed in an altitude

test chamber. Once a simulated altitude of 8500 feet was reached

power was removed from the analyzer and then restored. After the

unit was taken through its initialization procedures the altitude

was returned to sea level. Following removal from the chamber

and inspection, analyzers were again tested.

11
Salt/Fog Operation

Non-operating (powered down) analyzers were placed in a

salt/fog chamber for 30 minutes (3). The salt spray consisted of

a solution containing 5% salt by weight. The units were then

removed from the chamber and excess salt mist was removed from

the external surface. The machine was allowed to dry before

completing the testing.

Sand/Dust Operation

Non-operating (powered down) units were placed in a dust

chamber and exposed to a simulated dust storm for one minute (3).

The chamber used Fuller's Earth (Attapulgite) to simulate a storm

resulting in zero per cent visibility at 3 feet. The units were

tested after inspecting them for dust penetration and removing

excess dust.

In addition to information and data collected in Phases 1-3

of this study, summaries of instrument operational

characteristics were prepared by NSMRL medical laboratory

technical staff responsible for the operation and maintenance of

these machines. Their technical reviews focused on the

following! ease of set-up and operation, general durability

during testing, maintenance requirements, difficulties of repair,

availability of parts and technical support, availability of

reagents and controls and shelf-life of reagents. These

summaries are provided in Appendix A.

Phase 4: Summary and Reporting of Findings

In this phase, the findings from phases 2-4 were summarized

in a format which could be easily interpreted by Marine Corps

personnel. It was not possible to present the large volume of

data collected within the body of this report. Rather, primary

tests for each unit were summarized using a "Pass/Fail" method.

This system was used at each level for each testing condition. A

summary of the methodology and abbreviations used follows:

Hard Failure (HF): During certain portions of the

testing analyzers were severely affected and would not

operate. Specific error codes reported by individual units

are noted when available. Examples of this type of failure

include inability to properly calibrate the unit and damage

resulting from drop testing. "Hard Failures" includes cases

where 3 samples could not be run under a test condition.

Hard failures will be specifically addressed within the

results.

12
Pass (P): If a "Hard Failure" did not occur, three or

more samples were run at a each level. To receive a "Pass"

at a specific level an analyzer reported results within the

acceptable control range at least 65% of the time. To

receive an overall "Pass" for an individual test (e.g., WBC,

Na, etc.) at a particular test condition (e.g., cold

operation, altitude, etc.) an instrument must achieve the

65% goal for each level control.

Fail (F): A "Fail" is noted when at least 3 samples

were run on the analyzer but the results were within the

acceptable control ranges less than 65% of the time.

Instruments that failed only a single control level received

an overall "Fail" for that clinical test. For example, if

instrument A failed at level 1 control, but passed for

levels 2 and 3, it would receive a "Fl". Similarly, a F2,3

indicates failure at levels 2 and 3.

Not Tested (NT): In certain instances, analyzers could

not be tested under a specific condition for reasons other

than normal failures. For example, if a unit was damaged

during a previous test and could not be replaced, the

testing would be incomplete. A "Not Tested" is also used

when other breaks in protocol occurred and data was not

collected. These deviations in protocol will be addressed

specifically.

Not Applicable (NA): This category applied only to

operating temperature testing. If a machine "Passed" at

40OF it would not be tested at 50 or 60OF. Similarly, units

functioning at 100 or llO^F would not be tested at DO^F.

This was necessary to decrease the amount of time needed

within the environmental chambers and to limit the amount of

unnecessary data.

13
Results

Phase 1:

Based on information compiled in this phase, instruments

were selected that appeared suitable for field use based on their

physical size and clinical measurement capabilities. No

commercially available instrument capable of performing all

necessary tests was found. Automated instruments were not

identified for TCB, OPA, GSE and RPR. Automated analyzers

falling into six general classes would meet the measurement needs

stated by the project objectives. They are listed below along

with their primary testing requirements (please see the list of

abbreviations for acronyms):

1. Blood gas analyzers

Primary: PCO2, po2, pH

Secondary: Hgb, Hct, Na, K, Cl, Ca, Glu

2. Coagulation analyzers

Primary: PT, APTT

Secondary: TT, FIB

3. Hematology analyzers

Primary: WBC, RBC, Hgb or Hct, Pit

Secondary: MCV, MCHC, MCH, GRAN/LYMPH/MONO counts

4. Clinical chemistry analyzers

Primary: Glu, BUN, Cr

Secondary: Cholesterol, Liver Function Tests, Na,

K, Cl, CO2, Ca, UA, CK, Amyl, TBili,

Various Drug Levels

5. Electrolyte analyzers

Primary: Na, K, Cl

Secondary: CO2

6. Urinalvsis analyzers

Primary: Glu, Bili, Ketones, SG, pH, Protein,

Nitrates, Leukocytes

Specific analyzers from each of these groups were selected

for further testing. They are as follows:

14
Blood Gas Analyzers

1. Gemstat Mallinckrodt

2. CIBA 238 CIBA Corning

3. CIBA 288 CIBA Corning

4. NOVA 5 Nova Biomedical

Coaaulation Analvzers

1. Accustasis 2000 Sigma Diagnostics

2. Coagamate XM Organon Teknica

3. Factor VI International Technidyne

4. Biotrack 512 CIBA Corning

Hematoloav Analvzers

1. QBC Autoread Becton Dickinson

2. QBC Manual Becton Dickinson

3. Danaiti 510 Danam Corporation

4. Danam 820 Danam Corporation

5. CBC 5 Coulter Electronics

6. Celldyn 610 Abbott Diagnostics

Clinical Chemistrv Analyzers

1. COBAS Ready Roche Diagnostics

2. I-Stat I-Stat Corporation

3. Vision Abbott Diagnostics

4. Ektachem (modules) Eastman Kodak Co.

a. DT 60 II

b. DTSC

c. DTE

5. Reflotron Boehringer Mannheim

6. Nova 12 Nova Biomedical

Electrolvte Analvzers

1. 986S AVL

2. 644 CIBA Corning

3. Lytening 5 Baxter Diagnostics

Urinalysis

1. Clinitek 100 Miles Inc.

15
A more complete description of the 20 potential vendors is

provided in Appendix B. Reference ranges of control reagents

used by each analyzer are presented in Appendix C. The results

of Phases 2-4 are summarized for each class of instruments below.

Blood Gas Analyzers

Four blood gas analyzers were selected in phase I for

further testing (Table 1). The Gemstat and CIBA 238 are lighter

and more compact than the other two units. All measurements are

based on similar technologies and calibrate automatically. Each

analyzer performs the primary tests expected of this group (pH,

p02 and pC02), but the Gemstat, CIBA 288 and Nova Stat also

perform hemoglobin/hematocrit and serum electrolytes (Table 2).

There is a wide difference in cost per test among the analyzers

with the highest cost being $7.00/test for the Gemstat and the

lowest of $0.19 for the NOVA Stat 5.

Analytical performance evaluations using human blood samples

revealed no statistically significant (P<0.05) differences

between values obtained by the test instruments and the reference

analyzer under baseline conditions (Table 3). Standard deviation

were wide for both pC02 and p02 testing. This is because both

venous and arterial samples were used and blood was obtained from

hospitalized patients. These patients will exhibit wide

variation in these parameters based on their clinical status.

The Gemstat had the fewest number of failures during testing

at both 40OF and SO^F (Table 4). It received an overall "Fail"

for both of these conditions because of level 3 failures for p02

testing (143-177 mmHg). The CIBA 238, CIBA 288 and Nova Stat all

had multiple failures during 40 and SO^F operation. The CIBA 288

was the only unit to fail pH testing at 40OF. The Gemstat and

CIBA 238 operated adequately at SO^F for all primary clinical

tests and no units failed testing after being stored at -SO^F.

Compared to the other units, the Gemstat recorded the fewest

number of "Fails" when operated at lOO^F. It also operated

during combined high temperature/humidity testing. The Gemstat

was not tested at llO^F because it failed testing at lOO^F. The

CIBA 238 had a heater failure when tested at lOO^F. Data was

collected during QO^F operation of the CIBA 238 but results were

inadequate for p02(levels 2 and 3). The CIBA 238 received a

passing score for all tests at an elevated temperature and

humidity less than that used to test the Gemstat. The CIBA 238

was not tested at llO^F because a hard failure occurred at lOO^F.

The CIBA 288 failed at 90OF (for pC02) and lOO^F (pC02, pH).

Therefore, it was not tested at llO^F or high

temperature/humidity. The Nova Stat experienced an air-bath

temperature failure at 90OF and lOO^F and was not tested at llO^F

16
or under elevated temperature/humidity. All units functioned

adequately after storage at leO^F except the Nova Stat which had

a blower motor failure.

Temperature operation was repeated by allowing the control

reagents to remain at normal room temperature while the units

stayed in the environmental chambers (Table 5). This was not

done for the other groups of analyzers. The Nova Stat did not

undergo this additional testing because it could not be replaced

after being damaged during warm storage. With these changes,

only the Gemstat operated adequately at 400F with controls at

room temperature. The 238 functioned adequately at 50°F whereas

the 288 continued to fail level 3 p02 testing. The CIBA 288 also

failed at QO^F for pC02 tests and was therefore not tested at

IOQOF. A minor break in protocol occurred and the CIBA 238 was

not retested at IOOOF after it passed QO^F operation.

Each of the four machines operated under simulated

transportation and other operational conditions (Table 6) with

the exception of the CIBA 288 which had a pressure sensor failure

during altitude testing. After the CIBA 288 was returned to sea

level, it was functional and did not require replacement of the

pressure sensor. During the initial drop test of the Gemstat

analyzer an isolation transformer was broken. A replacement

machine was obtained and functioned satisfactorily during this

part of the test.

17
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Coagulation Analyzers

Four blood coagulation analyzers underwent operational

testing (Table 7). The Biotrack 512 is the smallest, lightest

and most portable of the machines. The reagent cartridges used

by the Biotrack 512 require the smallest amount of storage space

while the Factor VI's pre-packaged reagent tubes needed the most

storage space. No attempt was made to precisely quantify the

necessary amount of storage space. Each analyzer offered tests

of PT and PTT, while the Accustasis 2000 and Coagamate XM also

performed thrombin times and fibrinogen assays (Table 8). Time

required per test and cost per unit were similar, although the

Biotrack cost about $1,000 less.

During analytical performance testing, all coagulation

instruments performed in a statistically comparable fashion with

the reference analyzer except the Factor VI (Table 9). Factor VI

results were different statistically (P<0.05) than the reference

analyzer for both APTT and PT. The mean values obtained for both

these parameters were twice those of other instruments for APTT

and nearly four times those for PT. When the manufacturer was

consulted by the laboratory technician regarding this situation,

he was told that the normal ranges for APTT and PT values

measured on the Factor VI are different than other instruments.

Clearly, differences of this magnitude could result in clinically

significant differences in interpretation.

The Accustasis 2000 was the only unit to operate adequately

at both 40 and IIO^F (Table 10). It failed testing under

combined high temperature/humidity where results were inadequate

for PT and APTT. The test was not repeated at 90OF/90%RH. The

Accustasis also failed -SO^F storage testing. The Factor VI

passed testing during llO^F and 100OF/90%RH operation. The

Biotrack 512 only operated at SO^F and gO^F, reporting a "Room

Temperature Error" during 40, 50, 100 and llO^F operation. It

also could not tolerate elevated humidity and displayed a similar

error code. The Biotrack was the only machine which would not

operate (i.e.. Hard Failure) after being stored at ISO^F. The

Coagamate XM would not function at 40OF and llO^F, reporting a

"values out of range" error. It functioned adequately at lOO^F

ambient temperature but had difficulty at 50 and eO^F. Although

it initially failed during testing at 110OF/90%RH, retesting at

100OF/90%RH was successful. Storage temperatures did not affect

the Coagamate's performance. It should be noted that the

Coagamate failed level 2 APTT baseline testing by reporting a

scant 17/40 (43%) of samples within the reference range. The

Factor VI operated inadequately at lower temperatures, with

unsatisfactory results of control reagent testing at 40OF.

Interestingly, although data could be collected at 40OF, a fault

prompt occurred during 50OF operation and no data was obtained.

The Factor VI was the only unit to pass elevated humidity

testing.

24
There were no hard failures during the remainder of the

operational testing (Table 11). There were a variety of failures

noted for individual tests and conditions. The salt/fog and

sand/dust operation caused the greatest amount of difficulty for

this group of instruments. The Biotrack was the only unit to

pass all of these tests.

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HematoloaY Analyzers

Six hematology analyzers were evaluated (Table 12). The QBC

Autoreader was the smallest of the units tested. It required

less time for calibration and the least amount of storage space

for reagents. Although it normally uses whole blood controls in

a clinic setting, the unit can also be calibrated with a "check

rod" system which does not use whole blood. Additionally, it was

the only unit which did not use whole blood controls. All

analyzers perform white blood cell counts and measures of either

hemoglobin or hematocrit (Table 13). The QBC Autoreader, Danam

820, QBC Manual and Celldyn 610 also perform platelet counts.

Time to complete a single test was similar for each machine and

analyzer cost ranged from $5,000 to $11,000.

Analytical performance results demonstrated several

statistically significant (P<0.05) differences between values

obtained by the reference analyzer and test instruments (Table

14). These differences are summarized for each of the primary

parameters (and instrument) as follows: WBC (CBC 5 and Danam

510), Hot (CBC 5 and QBC Autoread) and RBC (CBC 5). No

significant differences were found for platelet counts and Hgb.

Although these differences were statistically significant, none

were considered clinically significant.

None of the machines operated properly at 40OF because the

cold environment caused crystallization of the reagents (Table

15). Several samples were run at 40OF for the QBC Manual, Danam

510 and CBC 5, but the results were unreliable and required

multiple runs for each sample. Although these units operated

marginally at 40OF their overall performance was not considered

adequate. The QBC Autoreader and Danam 510 were the only

analyzers to pass testing at SO^F. It should be noted that Hgb

testing was not completed at SO^F for the 510 because of

logistical problems. The CBC-5 was not tested at SO^F or eO^F

despite a single test failure at 40°F.

The QBC Autoreader and the QBC Manual were the only

analyzers capable of running samples at 110°F. The QBC

Autoreader received an overall "Fail" because of inadequate

performance for HCT and HGB tests. These two units were also the

only units to pass testing under high humidity/temperature, with

the QBC Manual capable of operating at the most extreme condition

(110OF/90%RH). During testing of the QBC Autoreader at

1100F/90%RH, the plastic stoppers became tacky which caused the

machine to jam. The Danam 510 reported a "room temperature too

high" error code during lOO^F operation.

The QBC Manual was not tested after -60 or leO^F storage

because the unit was damaged after the drop test and could not be

replaced. All of the other machines operated after warm and cold

storage except the CBC 5 because its bellows became warped during

31
storage. When the bellows were replaced the machine operated,

but it was not re-tested after ISOOp storage. The QBC Autoreader

recorded level 2 failures for all primary tests after -eO^F

storage.

During the vibration exposure, the Celldyn 610 experienced

an electronic failure and did not undergo drop testing (Table

16). A transducer broke during drop testing of the CBC 5

constituting a "Hard Failure". As previously mentioned, the QBC

Manual was damaged during the drop test and could not complete

environmental testing including salt/fog and sand/dust operation.

The CBC 5 reported a "flow-time error" during altitude testing.

The remainder of the machines operated under conditions of

vibration, altitude, salt/fog and sand/dust except for several

specific failures noted in Table 16.

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Baseline 40° 50° 60° 90° 100° IIQO TEMP/HUMID

(Op/RH)

-60O

STORAGE

F

160O

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QBC P HF P NA NA NA F P (100/90) P

AUTOREADER

WBC P P P P F2 P

Hct P P F2 P F2 P

Hgb P P Fl,2 P F2 P

Pit P P P P F2 P

QBC MANUAL P F F F NA NA P P (110/90) NT NT

WBC P Fl,2 Fl Fl P P

Hct P F2 Fl,2 P P P

Pit P Fl,2 Fl P P P

DANAM510 F F P* NA P HF NA F (90/90) P P

WBC P P P P P P P

Hct P P P P P P P

Hgb P F2,3 NT P F2 P P

RBC Fl P P P P P P

DANAM820 P HF NT P P HF NA F (90/90) P P

WBC P P P P P P

Hct P P P P P P

Hgb P P P Fl P P

RBC P P P P P P

Pit P P P Fl P P

CBC5 P F NT NT F* F* NA NA P HF

WBC P F2 F2 F2 P

Hct P P F2 Fl,2 P

Hgb P P F2 F2 P

RBC P P P P P

CELLDYN 610 P HF HF HF HF NA NA NA P P

WBC P P P

Hct P P P

Hgb P P P

RBC P P P

Pit P P P

* Hgb testily was not performed

# Level 3 testing not completed

P=pass; F=fail; NT=not tested; NA=not applicable; HF=hard failure

36
TABLE 16 - TRANSPORTATION AND OTHER CONDITION TESTING OF HEMATOLOGY ANALYZERS

VIBRATION/ ALTITUDE SALT+ SAND+

CARGO/DROP FOG DUST

QBCAUTOREADER P P* P P

WBC P P P P

Hct P P P P

Hgb P NT P P

Pit P P P P

QBC MANUAL

WBC

Hct

Pit

HE P

P

P

P

NT NT

DANAM 510 P P P P

WBC P P P P

Hct P P P P

Hgb P P P P

RBC P P P P

DANAM 820 F P P E

WBC F2 P P P

Hct P P P P

Hgb P P P Fl

RBC P P P P

Pit P P P P

CBC5 HE HE P E

WBC P P

Hct P P

Hgb P F2

RBC P P

CELLDYN 610 HE P P P

WBC P P P

Hct P P P

Hgb P P P

RBC P P P

Pit P P P

* Hgb testing not performed

P=pass; F=fail; NT=not tested; HF=hard failure

37
Chemistry Analyzers

Six clinical chemistry analyzers were procured for testing.

The I-Stat, a hand-held instrument powered by 9 yolt batteries,

was impressiyely small, lightweight (19.0 oz) and compact. The

NOVA 12, weighing 90 lb., was the most bulky (Table 17). The IStat had the highest average cost per test ($12.00/test), whereas

the Reflotron had the lowest ($1.40/test) (Table 18). The Cobas

Ready had the highest cycle time.

The tests performed by these units are shown in Table 19.

The Cobas Ready, Vision, Reflotron analyzers and DT 60 II/DTSC

modules provide the widest analytic capabilities. Included are

liver and renal function tests, cholesterol panels and drug level

testing.

Although phase II analytical performance evaluations

revealed statistically significant (P<0.05) differences between

several values obtained by the test analyzers and the reference

instrument, none of these differences were judged to be

clinically relevant by the physicians (Table 20).

The NOVA 12 was non-operational upon arrival at Fort Detrick

for environmental testing. Following discussions with the Marine

Corps project officer regarding repair of this instrument, it was

decided to eliminate the NOVA 12 from further consideration due

to its apparent lack of transportation durability and relatively

heavy weight. Therefore, operational testing was performed with

only five instruments.

Immediately before operational testing, the manufacturers of

the I-Stat provided an enhanced version of their standard

instrument. The enhanced version incorporated internal hardware

and software changes that were purported to allow the unit to

operate successfully at a wider ambient temperature range than

the standard unit. Both the standard and enhanced versions of

the I-Stat instrument were tested for operational performance

although the majority of tests were performed with the enhanced

model. Tables indicate which version of the I-Stat was tested.

The Cobas Ready and Vision were the only units to perform

adequately at 40OF (Table 21). The Ektachem was considered

overall non-operational at 40OF because two of the three modules

(DT 60 II and DTE) failed to operate properly. Although 10

samples were run with the Enhanced I-Stat at 40OF, this analyzer

displayed error codes during 5 of these tests and then shut down

completely. Both of these units passed testing at SO^F. All of

units experienced "Hard Failures" during testing at 110 and lOO^F

except the Cobas Ready. Although the Cobas Ready provided

results at lOO^F, values were out of range for level 1 and 2 BUN

testing. All machines operated successfully at 90OF except the

Vision which failed level 1 BUN testing. All machines operated

38
properly at elevated temperature and humidity except the Vision.

The Vision was the only instrument that failed after storage

at -eO^F. All chemistry analyzers passed the ISO^F storage test

except the Reflotron which was not tested because of the

inability to obtain reagents. The manufacturer of the Reflotron

then canceled their reagent contract with the Navy. It should

also be noted that creatinine testing (a primary test of the

chemistry analyzers) of the Reflotron was not completed because

of this problem.

All instruments tested, except the Ektachem, passed the

vibration, drop, altitude, salt/fog, and sand/dust tests (Table

22). Following the drop test, the Ektachem printer was nonoperational and because the printer is a controlling element of

the data logic flow for all three modules, none of the Ektachem

modules were able to function when the printer was disabled by

the test. This constituted a hard failure.

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TABLE 21 TEMPERATURE CONDITION TESTING OF CHEMISTRY ANALYZERS

Baseline 400 50° 60O 90° lOQO IIQO TEMP/HUMID

(Op/RH)

-60°

STORAGE

160°

STORAGE

COBAS READY P P NA NA P F HF P (90/90) P P

Glu P P P P P P P

BUN P P P Fl,2 P P P

Cr P P P P P P P

I-STAT (Enhanced) P HF P NA P HF HF P (90/90) P P

Glu P P P P P P

BUN P P P P P P

VISION P P NA NA F HF HF HF HF P

Glu P P P P

BUN P P Fl P

Cr P P P P

EKTACHEM P HF P NA P HF NA P (90/90) P P

(DT60)

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BUN P P P P P P

Or P P P P P P

REFLOTRON P HF HF F P HF HF P(90/90) NT NT

Glu P F2 P P

BUN P P P P

Cr* NT NT NT NT

NOVA 12 NT NT NT NT NT NT NT NT NT NT

* Creatinine not tested because of lack of reagents

P=pass; F=Fail; NT=not tested; HF=hard failure

45
TABLE 22 - TRANSPORTATION AND OTHER CONDITION TESTING OF CHEMISTRY ANALYZERS

VIBRATION/ ALTITUDE SALT+ SAND+

CARGO/DROP FOG DUST

COBAS READY P P P P

GIu P P P P

BUN P P P P

Cr P P P P

I-STAT (Enhanced) P P P P

Glu P P P P

BUN P P P P

VISION P P P P

Glu P P P P

BUN P P P P

Cr P P P P

EKTACHEM HP P P P

(DT60)

GL P P P

BUN P P P

Cr P P P

REFLOTRON P P P P

Glu P P P P

BUN P P P P

Cr* NT NT NT NT

NOVA 12 NT NT NT NT

* Not tested because of lack of reagents

P=pass; F=fail; NT=not tested; HF=hard failure

46
Electrolyte Analyzers

Three electrolyte analyzers underwent operational testing

(Table 23). Although similar in overall dimensions, the Lytening

5 at 11.0 lb. was less than half the weight of the AVL 986S and

slightly lighter than the Ciba 644 instruments. All instruments

use ion selective electrodes and calibrate automatically.

The AVL 986S is more expensive than the other two

instruments but it does offer an additional CO2 parameter (Table

24). The Lytening 5 had the fastest cycle time per test (7-15

sec). Cost per test was identical for all three instruments.

Analytical performance testing with human serum samples

(Table 25) revealed statistically significant (P<0.05)

differences in the following parameter (and instrument)

combinations relative to reference analyzer values: Na (986S),

Cl (AVL 986S and Ciba 644). The only potentially clinically

relevant difference occurred for Cl results obtained with the AVL

986S which were consistently higher than the reference analyzer.

The results of operational evaluation indicated that all

three instruments functioned adequately at temperature extremes

except for the AVL 986S which failed at single levels for Na and

Cl testing (Table 26). This unit was not tested at lOO^F or

90OF. The Ciba 644 was the only unit to pass testing at the

extreme of combined temperature and humidity. The AVL 986S

failed at 2 levels for Cl testing at 1100F/90%RH and was not

tested at a lower temperature and relative humidity. Level 3

testing (for Na, K and Cl) was not completed for the Lytening 5

at 1000F/90%RH because an electrode error code was displayed

after the completion of level 1 and 2 samples. This could be

considered a "hard failure". Warm and cold storage did not

present a problem for these units except that the Lytening 5

failed level 3 testing for potassium after I6OOF storage. It

should be noted that only level 1 potassium reagents were used to

test the Ciba 644 after -6OOF storage.

The results of all remaining tests demonstrated that this

class of instruments generally had outstanding operational

characteristics (Table 27). The single exception was the

Lytening 5 which failed the drop test (shorting of a circuit

board).

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Urinalysis Analyzer

Only one automated urinalysis instrument, the Clinitek 100,

was identified by the initial review for evaluation (Table 28).

This analyzer offers all basic studies required of this class of

instruments (Table 29). In addition to the test unit, samples

were run at the NAVHOSP Groton reference laboratory (Reference)

and manually by a laboratory technician at NSMRL (Manual). The

methods used by NAVHOSP Groton and NSMRL were the same. Primary

comparisons were made between the test analyzer and both

reference values.

Using human urine samples, the Clinitek yielded analytical

performance results for the specific gravity and pH parameters

which were not significantly different (P>0.05) than reference

values (Table 30). For some of the qualitative parameters (Keto,

Blood, Pro, and Uro) results from categorical statistical

evaluations indicated that the Clinitek 100 results differed

significantly (P<0.05) from those obtained by the reference

laboratory. Data for categorical variables is presented in

Appendix D. The difference for ketone analysis would have no

clinical relevance. For blood testing the Clinitek read 1 sample

as containing a "large" amount of blood and 1 as "medium" whereas

the reference laboratory found the samples were negative for

blood. Only 1 test for protein of 95 samples run could have had

minor clinical relevance (Clinitek read >30mg/dl and the

reference analyzer read negative). The test unit read various

levels of urobilinogen for 74 samples that the reference analyzer

noted as normal. Remaining categorical tests for bilirubin and

nitrates were not statistically different from the reference

analyzer.

The Clinitek 100 produced satisfactory test results under

all temperature condition testing except for a minor failure at

40<^F operation (Table 31). This was consistent with baseline

testing, where the Clinitek reported only 59/102 pH values within

the control range for pH. We cannot identify the acid/base

disturbance which caused this failure. Transportation and other

operational condition testing presented no difficulties for the

Clinitek (Table 32).

53
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Discussion

We found no single analyzer that could perform the majority

of tests desired by the Marine Corps. Additionally, the units

tested did not operate ideally under simulated field conditions.

It will be necessary to procure several analyzers with specific

clinical capabilities. Although there is a degree of overlap

between specific categories of machines, most analyzers are

designed to provide a specific group of related tests.

The final selection of any analyzer must take into account a

number of factors such as cost per analyzer, cost per test and

size/weight restrictions as well as performance during simulated

field conditions. These factors must be weighed by those

responsible for procuring these instruments for the Marine Corps.

Our intent was not to provide a "cost-effectiveness" analysis of

these instruments, but instead to present test results in a clear

and concise manner to facilitate final purchasing decisions.

Although the scope of operational testing was clearly defined, we

had no basis for which to rank in order of importance those

stated conditions. Also, it was unclear if there were any

conditions that these machines must operate under, with failure

to perform resulting in disqualification.

This study suffered from several design problems.

Initially, there were no pre-established criteria for the

"passing" or "failing" of machines during the operational

testing. The experience of the laboratory technician appeared to

influence the test results as more experienced technicians could

often trouble-shoot small problems and keep the instrument

running. This was especially evident during testing under

conditions of temperature extremes. It was noted that the

smaller machines could be "put under an arm" allowing them to

operate during cold exposure, even if only briefly. Except

during testing of blood gas analyzers, no effort was made to

determine if temperature was affecting the analyzer, the control

solutions or both of these.

The comparison of machines within each group was complicated

by the fact that analyzers used different single control

solutions. Individual controls were supplied by the analyzer's

manufacturer. The acceptable levels of each control were

different for each machine and not all levels were available for

every analyzer. This opens up the potential bias that a

manufacturer might deliberately set a more tolerant "acceptable"

control range. There were several problems encountered finding a

single standardized control that could be used within each class

of analyzer so this effort was abandoned. Further efforts in

this area should consider standardized controls or more reliance

on human samples.

59
Except in a limited number of instances, it was not possible

to compare the performance of analyzers within a group. Many

units simply failed under a given condition (e.g., did not

operate, an inadequate number of data points) or were not tested

for other reasons. If a machine operated at llOOp, it usually

was not tested at 90OF or lOOOp. This was necessary to decrease

the number a days within the environmental chamber. Obviously,

it is unfair to compare a machine tested at 110*^F and one

evaluated at lOOOp. Since analyzers perform different batteries

of tests, it is not possible to compare all possible test and

condition combinations (e.g., NA during lOO^F operation).

Instead, we focused on primary tests for each category of

machines.

One potential method of minimizing these difficulties would

be to develop a standardized testing procedure which could

minimize the variation in technique among operators. These

procedures would also simplify machine comparisons. It is unfair

to "rank" machines during operational testing if the decision

process used during the data collection process was unique to a

machine. By clearly defining what constitutes a "hard" failure

(the unit would not turn on, not report results or give readings

out of range) it would be possible to weed out inappropriate

units early in the process. Analyzers that survive the initial

round of testing could undergo more extensive evaluation.

Additional analyzers considered for procurement should

demonstrate capabilities which are similar to or exceed those of

the units tested. An expedited review process could be developed

to evaluate new technologies or advanced versions of existing

equipment. It would be reasonable to focus on the temperature

tolerance of units because most of the failures we encountered

occurred during temperature testing. Most units operated

satisfactorily during other aspects of testing. We believe that

useful information could be gained in a short time by minimizing

the amount of data collected and focusing on critical aspects of

operational relevance.

In general, the analyzers that we evaluated were not

designed to operate under these severe conditions. Although some

problems could be corrected with small changes in design, others

would require serious modifications. Close collaboration with

companies committed to continual improvement of their products

would be an effective method of minimizing in-house research and

development efforts.

Finally, there continues to be rapid progress in clinical

laboratory testing and biomedical instrumentation. Advances

should be closely followed by those involved in maintaining

laboratory capabilities for military operations. New

technologies will certainly be developed which may better

withstand the rugged conditions found in the field.

60
References

1. Commanding General, Marine Corps Research, Development and

Acquisition Command Itr 4400 Ser SSC/GP-42A of 18 May 1989.

2. Tukey JW. Comparing individual means in the analysis of

variance. Biometrics 1949:5:99-114.

3. Military Standard Environmental Test Methods and Engineering

Guidelines (MILSPEC) July 1989.

4. Commander, Marine Corps Systems Command Itr 6700 Ser

SSCGP/MED of 18 Aug 1992.

Acknovrledgements

The authors are indebted to the laboratory technicians who

without there perseverance and ingenuity this project would not

have been possible. They include HMl R. Hutchinson, HMl K. King

and Mr. L. Mooney.

61
List of Abbreviations

%

Alb

AlkP

ALT

Amyl

APTT

art

AST

Bill

BUN

Ca

Choi

CK

CKMB

Cl

CO2

Cr

CRP

dl

Fib

GGT

Glu

GRAN%

GRAN#

GSE

Hct

HDL

Hgb

K

KetO

LDH

LDL

Leu

LYM%

LYM#

MCH

MCHC

MCV

niEg

Mg

mg

N

Na

Nit

NH3

OPA

OSM

pH

Phos

Pit

PCO2

Percent

Albumin

Alkaline Phosphatase

Alanine Aminotransferase

Amylase

Activated Partial Thromboplastin Time

Arterial blood sample

Aspartate Aminotransferase

Bilirubin

Blood Urea Nitrogen

Calcium

Cholesterol

Creatinine Kinase

MB Fraction of Creatinine Kinase

Cloride

Carbon Dioxide

reatinine

C-Reactive Protein

deciliter

Fibrinogen

Gamma-GlutamyItrans ferase

Glucose

Granulocyte percent

Granulocyte number

Gram Stain Evaluation

Hematocrit

Hight density lipoprotein

Hemoglobin

Potassium

Ketones

Lactate dehydrogenase

Low density lipoprotein

Leukocytes

Lymphocyte percent

Lymphocyte number

Mean Cell Hemoglobin

Mean Cell Hemoglobin Concentration

Mean Corpuscular volume

milli-equivalent

Magnesium

milligrams

Number of samples

Sodium

Nitrate

Ammonia

Ova and Parasite analysis

Osmolality

pH (ACID/BASE)

Phosphorus

Platelets

Partial pressure carbon dioxide

62
p02 Partial pressure oxygen

Pro Protein

PT Prothrombin time

RBC RED BLOOD COUNT

RPR Rapid plasmin reagin (Syphilis test)

S.D. Standard deviation

ser serum sample

SG Specific gravity

T4 Thyroid hormone

TBili Total bilirubin

TCB Type and crossmatch of whole blood

TP Total Protein

Trig Triglycerides

TT Thrombin Time

UA Uric Acid

Urobil Urobilinogen

V Volts

wb whole blood sample

WBC White Blood Cell count

63
64
APPENDIX A

LABORATORY TECHNICIAN'S

INSTRUMENT TECHNICAL PROFILES

APPENDIX A - 1
Blood Gas Analyzers

gEMgTAT

This analyzer is relatively small, compact and easy to

operate. Reagents are provided in a self-contained cartridge

form that eliminates the use of gas tanks. Cartridges provide

sufficient reagent for 50 samples or until 72 hours after the

cartridge was inserted. Cartridges are stored at room

temperature. Installation and simple repairs are not

complicated. Laboratory technicians with average skills can

operate this unit. During the initial drop test an isolated

transformer became disconnected. A replacement instrument did

not experience this problem after repeating the drop test.

CIBA 238

This unit is small, compact unit and lightweight. All

reagents are contained in a pack which includes both buffer and

wash solutions. Analyzer requires one gas tank for operation (a

"mini" size is available). Installation and troubleshooting is

aided by flow chart instructions which were found to be

uncomplicated. A heater failure occurred during lOO^F operation.

The machine subsequently functioned when returned to room

temperature.

CIBA 288

This relatively large unit requires five different reagents

and two gas tanks during operation. Installation and

troubleshooting of unit is more complicated than the other units

tested despite a well written operator's manual. It did not

operate during altitude testing presenting a pressure sensor

failure message at high altitude. The analyzer did operate

normally after returning to sea level.

NOVA STAT 5

This analyzer is very large, heavy and requires a reagent

pack and two gas tanks for operation. Installation and

troubleshooting procedures are more complicated than the other

units evaluated, necessitating an operator with a higher than

average skill. The NOVA STAT 5 reported air bath temperature

failure error codes during high temperature testing before the

analyzer ceased to function. After storage at ISOOp the blower

assembly failed so that the analyzer was unable to reach the

normal operating temperature of 370F.

APPENDIX A - 2
COAGULATION ANALYZERS

ACCUSTASIS 2000

This instrument is small, compact and rugged. It is similar

to the fibrometer except that it uses turbo-densitometry for clot

detection. Most reagents are premixed and easily transportable,

however, they do require refrigeration. Operation could be

improved with the addition of a second time clock. Technical

support could be improved.

COAG-A-MATE XM

This analyzer is slightly larger and heavier than the other~

units tested in this group. It has the ability to perform

several tests simultaneously. The reagents require more skill to

reconstitute and APTT testing requires a higher operator skill

level than average. Difficulties were encountered during both

high and low temperature operation due to the inability of

reagents to coagulate. The COAGAMATE requires a technician with

above average skills who has received proper instrument

instruction.

FACTOR VI

The FACTOR VI is relatively small, lightweight and compact.

This unit requires individually wrapped tubes and a new reagent

vial for every four samples tested resulting in the need for

large amounts of refrigerated storage space. When tested in

extreme temperature conditions of llO^F and 90OF the sample tubes

sometimes overheated causing the coagulation levels to be above

the expected control ranges. Operation requires too many

technical steps to process samples efficiently and the skill

level of the operator must be above average.

BIOTRACK 512

This unit is relatively small, compact and lightweight,

using a newer technology which makes the analyzer basically

reagent free. It is easily portable and reagents require very

little storage space. The operation is not complicated. The

BIOTRACK will not operate in extreme heat and cold. It failed to

function at 40°F and 110OF/90%RH, directly affecting the laser

lights (2) and LED's with radical temperature changes. The

instrument was not affected by extreme storage temperatures.

Redesign of the cartridge to allow more room for sampling ease

would be helpful. Cartridge equilibration requires an incubation

period of 45 seconds per sample. Total sample time for PT is

APPENDIX A - 3
approximately 70 seconds, and approximately 3 minutes for APTT,

A minimal amount of excess equipment is required.

HEMAT0L06Y ANALYZERS

QBC AUTOREAD and OBC MANIIAT,

These analyzers did not function at 40OF because the

layering of phases was not distinct. These instruments are

unable to make readings when cell layers are poorly defined.

During human sample testing 2 samples out of 100 could not be

analyzed by the machines because of the absence of layering.

This was probably caused by anemia in these subject's specimens

which affected red cell distribution in the tube. These results

would need to be verified by further testing, using an

alternative hematology method.

These units did not function smoothly at high temperature

and high humidity because the rubber closures at the end of tubes

became tacky and caused the tubes to stick in the instrument.

The AUTOREAD was unable to read tubes at 110OF/90%RH because it

continually jammed (although it did operate at 100OF/90%RH).

HC 510 and HC 820

Extremes in temperature affected the reagents of these

instruments which are isotonic solutions. Cold temperatures

(below SOOp) cause salt to precipitate out of solution, changing

the conductivity of reagents which results in machine alerts and

unreliable test results. High temperatures (above 900F) cause

evaporation of solutions which also changes the concentration of

salts in solution and affects test results. Both instruments are

easy to operate and extremely reliable in a stable environment.

They are also reliable after being moved once they are

restabilized and recalibrated.

CPC 5

The bellows of this instrument were damaged after being

stored in high temperature conditions. The bellows control the

amount of reagent and samples that are aspirated for analysis.

It also would not function during high frequency testing because

a capacitor was lost from the main computer card. Extremes in

temperature affected isotonic reagents as described above for the

HC 510 and HC 820. This unit would not give results at high

temperatures (QO^F), although it produced a few results for

certain tests at low temperatures (400F).

APPENDIX A - 4
CELLDYNE 610

The dilutor of this analyzer was affected by exposure to

extreme temperatures. The expansion and contraction of seals

during operation in hot and cold temperatures caused inaccurate

aspiration and subsequent dispensing of reagents and samples. An

unprotected reagent inlet tip on the dilutor was broken after

storage at -600F. This instrument would not pass initial

internal checks after the high frequency test. A power source

assembly needed to be replaced during testing.

CHEMISTRY ANALYZERS

I-STAT

The I-STAT is a relatively small, lightweight and compact

hand-held unit that requires no maintenance, no manual

calibration and uses only an electronic simulator to verify

proper operation of the unit. It is powered by two 9-volt

batteries and is capable of storing the results of fifty patient

samples at a time. These results can be reviewed in any order

and printed using a hand-held printer unit that is also battery

operated. The I-STAT can also be interfaced with a computer

system if desired.

This system requires only a pre-packaged, pre-measured

reagent cartridge to achieve patient results. Reagents and

controls require a minimum amount of refrigeration space. A 65ul

patient sample is needed. The I-STAT analyzes patient samples in

90 seconds and samples are easily repeated. It is recommended

that a storage case (e.g. Playmate cooler) that could protect the

unit from these conditions be considered.

COBAS READY

The COBAS READY is a small, compact and reasonably

lightweight instrument. It utilizes a dry chemical reagents in a

stick form. These are prepackaged, compact and do not require

refrigeration. Calibration is achieved through an innovative

"credit card" type program. Calibration fluids and controls

require a small amount of refrigerated storage space.

This unit is capable of performing six individual tests or

one "profile" at a time requiring approximately seven minutes per

cycle for the parameters tested. A minimal patient sample is

needed and operation can be learned during a small amount of

training. The instrument can be left unattended during operation

APPENDIX A - 5
and hard copy results are automatically printed when each cycle

is complete.

Minimal damage was sustained during the drop test. This

model requires very little maintenance and is user friendly.

Since this unit was purchased and tested, Roche/Baxter has

ceased producing and marketing this instrument. Production has

been resumed by a new company, Hichem, located in Lincoln, Rhode

Island. The unit is now marketed under the name "SPOT CHEM"

which requires updated software to utilize new reagents

manufactured by Hichem versus reagents used by the COBAS READY.

This unit should be investigated as a suitable replacement for

the COBAS READY.

The VISION is heavier and larger than the other units

tested, however, it is unique in its operation. It has a selfcontained centrifuge and uses a pre-measured reagent pack. No

additional reagents are necessary for the operation of this piece

of equipment with the exception of controls and calibration

fluids which require a small amount of refrigerated storage

space. The prepackaged reagent packs also require refrigeration.

This unit is capable of performing up to ten tests (with the

exception of prothrombin time) in any test combination with a

minimum of patient sample needed. It is precalibrated on

installation and does not need to be recalibrated until control

lot number changes or the instrument is transported. Calibration

was well maintained during testing and it can operate unattended

during the cycle.

The VISION requires minimal maintenance and troubleshooting

is rarely necessary. If repairs are needed, they are usually

facilitated by using an exchange program with the manufacturer.

It was noticed during environmental testing that the VISION has

limited temperature tolerance. Cold storage was not well

tolerated and caused sensor failure. This unit was replaced and

testing continued. The VISION is easy to use and can be operated

with a small amount of training.

REFLOTRON

The REFLOTRON is a light weight and compact unit which

operates with or without the keyboard. Reagents utilize a dry

chemical technology in strip form that does not require

refrigeration. A minimal patient sample is needed to complete

testing. Controls are lyophilized and require refrigeration.

This unit performs one test at a time, requiring

approximately three minutes per test strip. Minimal maintenance

APPENDIX A - 6
is required. Calibration requires only a "CHECK STICK". Storage

tests were not completed on this unit.

The REFLOTRON appeared to function slowly. This instrument

was not well supported by the company during our testing. It was

very difficult for us to obtain reagents. Reflotron's purchasing

department's lack of responsiveness made it impossible to

complete the last two testing conditions.

KODAK DT 60 II

The DT 60 II is heavier and bulkier than the other

instruments in this category. It utilizes three modules, the DT

60 II, DTE, and DTSC, all of which are dependent on the DT 60 II

module for operation. It utilizes dry chemistry technology

provided in prepackaged, prepared slide format that requires

refrigeration. Controls and calibrators require refrigeration

and/or freezer space. Recalibration is required when the

instrument is unplugged and moved and it has no memory

capabilities. Calibration requires approximately 60 minutes to

complete for our testing needs.

The DTSC and DTE modules can perform only one test at time,

with one in waiting status, while the DT60 II module can analyze

three to six samples at a time. Each test requires approximately

three minutes. They utilize pre measured electronic and manual

pipettes but it was noted that the plastic pipette tips do not

stay securely on pipettes and reagents tend to stick on the tip

resulting in numerous dispensing errors. The slides do not move

smoothly on the tracks, often becoming out of alignment causing

the corners of the slides to become caught in the mechanism

resulting in numerous error codes and wasted slides. Opening

covers to the modules for slide adjustments results in loss of

time and causes additional warming of the modules.

This unit does not operate in extreme high or low

temperatures, reporting temperature too hot or temperature too

low error codes. The printer was damaged during the drop test

sequence. Although all modules were operational after this

portion of testing, the instrument could not display results.

During 160°F storage the DTSC module experienced warping of

plastic casing and rubber chain links causing mechanical

breakdowns during the testing sequence. The unit overheated at

approximately 1000 feet during altitude testing.

NOVA 12 CRT

This analyzer is large and bulky. It requires a prepackaged

reagent pack for operation and the control solutions require

refrigerated storage space. The NOVA 12 utilizes three membraned

ISE electrodes which require frequent replacement. It requires

APPENDIX A - 7
more maintenance and troubleshooting than other units in this

category.

This unit operated in the laboratory under controlled

conditions after significant amounts of daily maintenance and

repair. It experienced frequent BUN and Glu membrane

replacements and reagent flow error requiring time consuming

troubleshooting and repair sessions before daily operation could

be resumed.

On transport to the environmental testing chambers, this

analyzer would not achieve satisfactory calibration and/or ceased

to operate completely. It could not be tested under any

environmental condition. Repair technicians were present and

repairs initiated on four separate occasions during the

environmental test period.

ELECTROLYTE ANALYZERS

AVL 986 S

The AVL 986 s is a small, compact and relatively lightweight instrument. Installation and disassembly is

uncomplicated. It operates using a single membraned ISE

electrode. Liquid reagents are supplied in small prefilled

bottles that are readily accessible and easily replaced.

Operation is simple and once one is familiar with the software

tree, can be performed easily by the average technician.

Trouble-shooting is easy to manage and maintenance is simple.

Daily electrode maintenance must be performed before routine

operations can be started. This usually involves about ten

minutes of a technicians attention.

Controls are provided in ampule form and require a minimal

amount of refrigerated storage space. Bottled reagents require a

small amount of shelf space but are stored at room temperature.

Warping of the plastic cover was noted after heat storage

test and the housing cracked after drop test. However, the unit

continued to function during both of these tests. This analyzer

can be assembled and disassembled in approximately ten to fifteen

minutes. Electrodes can be assembled and placed into position in

approximately five minutes or less.

This unit is self-calibrating and no manual calibration was

required during environmental testing. It would calibrate within

one or two cycles after set-up. It is recommended that hinges

replace magnets on the front panel because magnets become loose

from the housing with continued use.

APPENDIX A - 8
LYTENING 5

The LYTENING 5 is a small, compact and light-weight

instrument. It operates with single membraned ISE electrodes.

Replacement of the reference electrode membrane and reference

tablets is required every two weeks. Maintenance is simple to

perform, however, special attention is required when replacing

the reference electrode.

Reagents are supplied in pre-filled bottles that are housed

on the outside of the instrument and are easily replaced.

Controls are provided in ampule form that requires little storage

space. Neither reagents or controls require refrigeration.

During temperature condition testing the reagents would change

temperature rapidly because of lack of thermal protection,

causing the electrodes to have difficulty analyzing samples. A

large amount of moisture would collect under the front cover and

in the electrode sleeves which could cause malfunctioning. The

fluids inside the reference electrode would become very hot and

perforate the membrane cap.

After storage at -60OF, the printer ceased to function.

This instrument is dependent on the printer for communication and

will not analyze samples if the printer is not capable of

retrieving results from the system. The printer assembly can be

easily replaced by the operator or biomedical repair person.

Few problems resulting in down time were encountered. It is

recommended that a cover be placed over the reagent compartment

to aid in temperature control if this unit is considered for

field use.

CIBA 644

The CIBA 644 is a small, compact, and lightweight instrument

with prepared reagent packs housed on the outside of the unit.

Controls are furnished in an ampule form that requires a small

amount of shelf space. No refrigeration is required. This unit

has interchangeable electrodes with no membranes. Electrodes are

interchangeable with those from any CIBA analyzer in the 200 or

600 series. Basic maintenance is required only when the reagent

pack is changed approximately once weekly depending on usage.

This involves approximately ten minutes.

The CIBA 644 is self-calibrating and requires no manual

calibrations. Reagents are housed on the outside of the

instrument and are unprotected from extreme environmental changes

which may cause analytical difficulties because of rapid

fluctuations in the temperature of solutions passing through the

electrodes. A cover over the reagent compartment could lessen

this problem. Troubleshooting and maintenance of the instrument

can be accomplished by the average technician.

APPENDIX A - 9
It was noted that the installation and transportation of the

instrument was accomplished with ease over a short period of

time. The unit would usually calibrate within one or two cycles

after assembly.

URINALTSIS ANALYZER

CLINITEK 100

This unit is lightweight, compact and user friendly. It

utilizes dry chemical strips as reagents. The printer had

difficulty after sand exposure. Maintenance requirements are

minimal and troubleshooting is rarely necessary. It can be

operated with minimal instruction and does not require the

operators attention during the test cycle.

APPENDIX A - 10
APPENDIX B

NAMES AND MANUFACTURERS OF

INSTRUMENTS TESTED

APPENDIX B - 1
Blood Gas Analyzers

Ciba 288

+ Ciba 238

Ciba-Corning Diagnostics

63 North Street

Medford, MA 02052

Nova Stat 5 Nova Biomedical

200 Prospect Street

Waltham, MA 02254-9141

Gemstat Mallinckrodt Sensor Systems

122 Eisenhower Place

Ann Arbor, MI 48108 9

Coagulation Analyzers

f

Biotrack 512 Ciba Corning Diagnostics

63 North Street

Medfield, MA 02052

Accustasis 2000 Sigma Diagnostics

P.O. Box 14508

St. Louis, MO 63178

Coageunate-XM Organon Teknika

100 Akyo Avenue

Durham, NC 27704

Factor VI Baxter Diagnostics, Inc.

1430 Waukegan Road

McGaw Park, IL 60085-6787

Hematology Analyzers

QBC Manual

+ QBC Autoread

Benton Dickinson, Primary Care

Diagnostics

7 Loveton Circle, P.O. Box 370

Sparks, MD 21151-0370 »

Cell-Dyn 610 Abbott Diagnostics Division

850 Maude Ave

Mountain View, CA 94043 •

Danam HC 510

+ HC 820

Danam Electronics

4230 Shilling Way

Dallas, TX 75237

CBC 5 Coulter Electronics

Corporation

1090 Northchase Parkway

Marietta, GA 30067

APPENDIX B - 2
Chemistzy Analyzers

Nova 12 CRT Nova Biomedical

200 Prospect Street

Waltham, MA 02254-9141

Vision Abbott Diagnostics

One Abbott Road

Abbott Park, IL 60064-3500

I-Stat I-Stat Canada, Ltd

436 Hazeldean Road

Kanata, Ontario K2L1T9

Cobas Ready Roche (Baxter Scientific)

One Sunset Avenue

Monclair, NJ 07042-5199

Reflotron Boehringer-Mannheim Corporation

9115 Hague Road

Indianapolis, IN 46256

DT60 II Eastman Kodak Company

343 State Street

Rochester, NY 14650

Electrolyte Analyzers

Ciba 644 Ciba Corning Diagnostics

63 North Street

Medfield, MA 020502

Lytening 5 Baxter Healthcare Corporation

Scientific Products Division

1430 Waukegan Road

McGaw Park, IL 60085-6787

AVL 986S AVL Scientific Corporation

33 Mansell Court, P.O. Box 337

Rosewell, GA 30077

Urinalysis Analyzer

Clinitek 100 Miles Laboratories, Inc.

Diagnostic Division

P.O. Box 3100

Elkhart, IN 46515-3100

APPENDIX B - 3
APPENDIX B - 4
APPENDIX C

REFERENCE RANGES FOR CONTROL REAGENTS

APPENDIX C - 1
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RESULTS OF CATEGORICAL VARIABLE ANALYSIS

FOR URINALYSIS ANALYZER

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I
UNCLASSIRED _

SECURITY CLASSIFfCATION OF THIS

REPORT DOCUMENTATION PAGE

1 a. REPORT SECURITY CLASSIFICATION

2a. SECURITY CLASSIFICATION AUTHORITY

2b. DECLASSIFICATION/DOWNGRADING SCHEDULE

4. PERFORMING ORGANIZATION REPORT NUMBER(S)

NSMRLReport 1191

6a. NAME OF PERFORMING ORGANIZATION 6b. OFFICE SYMBOL

Naval SubmarineMedical Research (IfApplicable)

6c. ADDRESS (City, State, Zip Code)

Box900, Naval SiimarineBaseNLON,

Gioton,Cr06349-5900

8a. NAME OF FUNDING/SPONSORING

ORGANIZATION

Same as 7a

8b. OFFICE SYMBOL

(IfApplicable)

8c, ADDRESS (City, State, Zip Code)

SameasTb

Form Approved

0MB No. 074-0188

1 b. RESTRICTIVE MARKINGS

3. DISTRIBUTION/AVAILABILITY OF THE REPORT

i^ppDvedfbrpublic release; distribution unKmfed

5. MONITORING ORGANIZATION REPORT NUMBER(S)

NA

7a. NAME OF MONITORING ORGANIZATION

Naval MedkalReseaidi andDevelopmentQmmand

7b. ADDRESS (City, State, Zip Code)

8901 WisocmanAvenue

Belhes(to,MD20889-5606

9. PROCUREMENT INSTRUMENT IDENTIFICATION NUMBER

10. SOURCE OF FUNDING NUMBERS

PROGRAM

ELEMENT NO.

637D6N

PROJECT NO.

M000095

TASK NO.

005

WORK UNIT

ACCESSION NO.

DN241527

11. TITLE (Include Security Classification)

Evaluation offidddinicallabMatHyequpnentfa:FketN^rine^^

12. PERSONAL AUTHOR(S) P.LPeiDtta,CBoleo±-ac^gS»EM.C3irist,andD. W.HobsMi

13a. TYPE OF REPORT

Tiitprim

16. SUPPLEMENTARY NOTATION

13b. TIME COVERED

PROM TO

14. DATE OF REPORT (year, MantftOaK) 15. PAGE COUNT

17. COSATI CODES

FIELD GROUP SUB-GROUF

18. SUBJECT TERMS (Continue on reverse ifnecessary and identify by block number)

Oinicallaboratotyequipmait, Fieldlaboratory

19. ABSTRACT (Continue on reverse ifnecessary and identify by block number)

We evaluated clinical laboratory equipment being considered for purchase by the U.S. Marine Corps. This

equipment will provide clinicians with rapid access to laboratory data during deployments. Capabilities were

desired in the following areas: hematology, chemistry, coagulation, blood gas analysis and urinalysis. There

is concem that severe conditions encountered in the field may affect machine performance.

Analyzers were evaluated under each ofthe following conditions: ambient temperature range (40oF to

llOoF), combined heat/humidity, extreme storage temperatures (-6O0F and I6O0F), simulated transport

(vibration, drop testing), ahitude (8500 ft), salt/fog and sand/dust operation. Results are presented separately

for each class of analyzer. No singular "winner" or "looser" stood out in any category. In general,

instruments had difficulty with warm and cold temperature operation.

This information can be used by Marine Corps personnel involved with providing clinical laboratory

equipment to operational forces. Other factors which should be considered include instrument size, storage

rt^qiiirpments ease of use and cost.

20. DISTRIBUTION/AVAI LABILITY OF ABSTRACT

_^UNCLASSIFIEDAJNLIMITED^SAME AS „DTIC USERS

22a. NAME OF RESPONSIBLE INDIVIDUAL

Susan D. MMity, PuHkations OflBce

21. ABSTRACT SECURITY CLASSIFICATION

22b. TELEPHONE (Include Area Code)

(203)445^3967

22c. OFFICE SYMBOL

DD R>rm 1473, JUN 86 Previous editions are obsolete.

S/N 0102-LF-014-6603

SECURITY CLASSIFICATION OF THIS

PAGE

I iM/«i A^^ieien