This document applies to the latest higher software version.
When a subsequent software version changes the information in this document, a new issue will be
released.
1.1. Notice of liability
The information in this manual is distributed on an ’’as is’’ basis, without warranty. While every
precaution has been taken in the preparation of the manual, ABX DIAGNOSTICS shall have any liability to
any person or entity with respect to liability, loss, or damage caused or alleged to be caused directly or
indirectly by the instructions contained in this manual or by the computer software and hardware
products described herein.
1.2. Trademarks
Other product names mentioned within this publication may be trademarks or registered
trademarks of other companies.
1.3. Copyright ® 2002 by ABX DIAGNOSTICS
All rights reserved. No part of this book may be reproduced or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written
permission of ABX DIAGNOSTIC S.
ABX DI AGNOS TICS
Parc Euromédecine
Rue du caducée
B.P. 7290
34184 MONTPELLIER Cedex 4 - FRANCE
Tel: (33) (0)4 67 14 15 16
Fax: (33) (0)4 67 14 15 17
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2. Working conditions
2.1. Environment
The Pentra 80 should be operated in an indoor location only. Operation at an altitude over 3000
meters (9800 feet) is not recommended. Instrument is designed to be safe for transient voltages
according to INSTALLATION CATEGORY II and POLLUTION DEGREE 2.
Please ask your ABX Diagnostics representative service center for any information about the operating
location when it does not comply with the recommended specifications.
2.2. Location
The Pentra 80 should be placed on a clean and leveled table or work station. Please note that the
Pentra 80, printer and reagents weigh approximately 40 kilograms (88 lbs). Avoid exposure to sunlight.
Proper ventilation requires that a space of at least 20 cm (8 inches) must be left behind the instrument.
2.3. Grounding
INTRODUCTION
Proper grounding is required. Check that the wall ground (earth) plug is correctly connected to the
laboratory grounding electricity installation.
If there is no ground then use a ground stake. Current electricity Standards must be applied.
2.4. Humidity and temperature conditions
The Pentra 80 must function between 16 to 34°C (61 to 93°F). Maximum relative humidity 80% for
temperatures up to 31°C (88°F) decreasing linearly to 50% relative humidity at 40°C (104°F). If it is kept
at a temperature of less than 10°C (50°F), the instrument should be allowed to sit for an hour at the
correct room temperature before use.
2.5. Electromagnetic environment check
The Pentra 80 as been designed to produce less than the required level of electromagnetic
interferences in order to operate in conformity with its destination. The electromagnetic interferences
caused by the Pentra 80 are limited to a level allowing the correct operation of other instruments in
conformity with their destination.
In case of problems, check that the instrument is not placed in proximity of electromagnetic fields,
or short wave emissions (radars, X-rays, scanner, etc...).
2.6. Environment protection
Used accessories and consumables must be collected by a laboratory specialized in elimination
and recycling of this kind of material according to the legislation.
In order for the instrument to operate correctly, hight-quality reagents must be used.
ABX DIAGNOSTICS provides all the necessary reagents.
All these reagents have been registered by the A.F.S.S.A.P.S. «Agence Française de Sécurité Sanitaire des Produits de Santé» according to the procedure relative to laboratory reagents
used for biological analyses.
These reagents are used for in vitro diagnostics.
All these reagents are manufactured by:
ABX DIAGNOSTICS
Rue du caducée - Parc Euromédecine
34184 MONTPELLIER CEDEX - FRANCE
Tel: (33) 4 67 14 15 16 - Fax: (33) 4 67 14 15 17
4.1. ABX DILUENT
• Function: This diluent is necessary for the process involved in counting (and differentiating) the
blood cells. This reagent is used also to rinse the hydraulic parts of the instrument.
• Composition: Stabilized saline solution which contains an organic buffer, an antiseptic and
Sodium Azide < 0.1%.
• Description: Limpid and odourless aqueous solution.
• Physico-chemicalproperties: Boiling point: About 100°C, pH: neutral.
• Mesuring Principles: See user manual.
• Performances: See user manual.
• Results: See user manual.
• Directions for use: See user manual.
• Handling Precautions: Avoid skin and eye contact. Use laboratory gloves when handling the
reagents. If a large quantity of reagent is ingested a mucous irritation can result.
• Emergency First aid: If the eyes or skin come into contact with the reagent, rinse thoroughly with
water. If a large quantity is ingested, drink water immediately, and induce vomiting.
• Storageconditions: Stored at 18°C (65°F) to 25°C (77°F) away from light.
• ABX DIAGNOSTICS Part number: 0901020
4.2. ABX ALPHALYSE
• Function: This reagent is used to lyse blood cells and determine hemoglobin concentration.
• Composition:The reagent contains potassium cyanide at 0.03%, a quarternary ammonium salt
and a saline phosphate buffer containing sodium azide < 0.1%.
• Description: Aqueous solution, limpid.
• Physico-chemical properties: Boiling point: approximately 100°C. pH: basic, smells of cyanide.
• Mesuring Principles: See user manual.
• Performances: See user manual.
• Results: See user manual.
• Directions for use: See user manual.
• Handling Precautions: May be dangerous. Avoid contact with eyes, skin and clothing. Wear
laboratory gloves when handling the product. The product may be harmful if ingested. The product
can be absorbed through an open wound, or inhalation.
• Emergency First aid: If the eyes or skin come into contact with the reagent, rinse with water. If
the reagent is inhaled, breathe fresh air immediately. If a large quantity is ingested, drink water
immediately, and induce vomiting. Call anti-poison center, or contact doctor.
• Storage conditions: Stored at 18°C (65°F) to 25°C (77°F) away from light. Product will degrade if
exposed to air, keep cap / probe assembly securely tightened.
• ABX DIAGNOSTICS Partnumber: 0906004
4.3. ABX BIOLYSE
• Function: This reagent is used to lyse blood cells and determine hemoglobin concentration.
• Composition:Quarternary ammonium chloride.
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SECTION 1SPECIFICATIONS
• Description: Colorless, odorless.
• Physico-chemical properties: pH: 6.65
• Handling Precautions: May be dangerous. Avoid contact with eyes, skin and clothing. Wear
laboratory gloves when handling the product. The product may be harmful if ingested.
• Mesuring Principles: See user manual.
• Performances: See user manual.
• Results: See user manual.
• Directions for use: See user manual.
• Emergency First aid: If the eyes or skin come into contact with the reagent, rinse with water. If
the product is ingested, call immediately a doctor.
• Storage conditions: Stored at 18°C (65°F) to 25°C (77°F) away from light..
• ABX DIAGNOSTICS Part number: 0906005
4.4. ABX CLEANER
• Function: Washing agent.
• Composition: Enzymatic solution with proteolytic action.
• Description: Transparent liquid.
• Physico-chemical properties: Boiling point: around 100°C. pH: 9.6
• HandlingPrecautions: May be harmful. Avoid contact with eyes, skin and clothing.
• Mesuring Principles: See user manual.
• Performances: See user manual.
• Results: See user manual.
• Directions for use: See user manual.
• Emergency First Aid: In case the product comes into contact with the eyes, rinse with water. If
the product is ingested, call a doctor immediately.
• Storage conditions: Stored at 18°C (65°F) to 25°C (77°F).
• ABX DIAGNOSTICS Partnumber: 0903010
4.5. ABX EOSINOFIX
• Function: This reagent lyses RBCs, fixes leukocytes and gives a specific coloration to
• Description: Deep blue aqueous solution, smells of alcohol.
• Physico-chemical properties: pH: 6.9
• Handling precautions: Avoid contact with eyes, skin and clothing. Wear laboratory gloves when
handling the product. The product may be harmful if ingested or inhalted. Keep the bottle closed
when not in use.
• Mesuring Principles: See user manual.
• Performances: See user manual.
• Results: See user manual.
• Directions for use: See user manual.
• Emergency First Aid: If the eyes or skin come into contact with the reagent, rinse with water. If
the reagent is inhaled or ingested, call local anti-poison center or contact doctor.
• Storage conditions: Room temperature between 18°C (65°F) to 25°C (77°F).
• ABX DIAGNOSTICSPart number: 0206010
4.6. ABX BASOLYSE II
• Function: This reagent lyses RBCs for the leukocytes and differential count of the polynuclear
basophils.
• Composition: Acidic solution containing a lytic agent.
• Description: Colorless aqueous solution.
• Physico-chemical properties: pH: 2.4
• Handling precautions: Avoid contact with eyes, skin and clothing. Wear laboratory gloves when
handling the product. The product may be harmful if ingested or inhalated. Keep the bottle closed
when not in use.
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PENTRA 80 TECHNICAL MANUALRAA022AA
• Mesuring Principles: See user manual.
• Performances: See user manual.
• Results: See user manual.
• Directions for use: See user manual.
• Emergency First Aid: If the eyes or skin come into contact with the reagent, rinse with water. If
the reagent is inhaled, breath fresh air immediately. If a large quantity is ingested, drink water
immediately. Do not induce vomiting. Call local anti-poison center or contact doctor.
• Storage conditions: Room temperature between 18°C (65°F) to 25°C (77°F).
• ABX DIAGNOSTICS Part number: 0906003
4.7. Waste handling precautions
If required, waste can be neutralized before being discarded. Follow your laboratory’s protocol
when neutralizing and disposing of waste.
5. Limitations
5.1. Maintenance
In Chapter 8. Maintenance, specific maintenance procedures are listed. The maintenance
procedures identified are mandatory for proper use and operation of the ABX PENTRA 80.
Failure to execute any of these recommended procedures may result in poor reliability of the
system.
5.2. Blood specimens
Verification of any abnormal test result (including flagged results or results outside of the normal
range) should be performed using reference methods or other standard laboratory procedures for
conclusive verification of the results. The sections below list known limitations of automated blood cell
counters which use the principles of impedance and light absorbance as principles of measurement.
5.3. Known interfering substances
WBC:
• White Blood Cells (Leukocytes):WBC results that exceed the linearity limits of the system will
require dilution of the blood sample (Leukemia sample followed by a leukopenia). Re-assaying the
diluted sample will help to obtain the correct assay value.
• Unlysed Red Cells - In some rare instances, the erythrocytes in the blood sample may not be
completely lysed. These non-lysed red blood cells may be detected on the WBC histogram with an
L1 alarm or as an elevated baseline on the side (leading edge) of the lymphocytes population. Non-
lysed erythrocytes will cause a falsely elevated WBC count.
• Multiple myeloma - The precipitation of proteins in multiple myeloma patients may give high
WBC counts.
• Leukemia - A very low WBC count may result from this disease because of possible increased
fragility of the leukocytes leading to destruction of some of these cells during counting. These white
cell fragments will also interfere with the white cell differential parameters.
• Chemotherapy - Cytotoxic and immunosuppressive drugs may increase the fragility of the
leukocytes which may cause low WBC counts.
• Cryoglobulins - Increased levels of cryoglobulin that may be associated with myeloma,
etc, which can increase the WBC, RBC or Plt counts and the Hgb concentration. The specimen
must be warmed up to 37°C (99°F) in a bain marie for 30 minutes and analyzed again immediately
after (analyzer or manual method).
• Macrothrombocytes - in excessive numbers may affect and increase Leukocyte numeration.
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SECTION 1SPECIFICATIONS
RBC:
• Red Blood Cells (Erythrocytes): The red blood cell dilution contains all the formed elements in
the blood: erythrocytes, leukocytes and platelets. During erythrocytes counting (red blood cells),
platelets are not counted as their size falls below the minimum threshold.
• Agglutinated erythrocytes - May cause a low incorrect RBC count. Blood samples containing
the agglutinated red blood cells may be suspected by elevated MCH and MCHC values and shown
by examination of the stained blood film.
• Cold agglutinins - IgM immunoglobulins which are high in cold agglutinin disease may cause
lower RBC and Plt counts and increase MCV.
Hgb (Hemoglobin):
• Turbidity of the blood sample - Any number of physiological and/or therapeutic factors may
produce high incorrect Hgb results. To obtain accurate hemoglobin results when increased turbidity
of the blood sample occurs, determine the cause of the turbidity and follow the appropriate method
below:
• High WBC: An extremely high WBC will cause excessive light scatter. In these cases use
reference (manual) methods.The diluted sample should be centrifuged, and the supernatant fluid
measured with a spectrophotometer.
• High lipid concentration: A high concentration of lipids in the blood sample will give the plasma
a «milky» appearance. This condition can occur with hyperlipidemia, hyperproteinemia (as in
gammapathies) and hyperbilirubinemia. Accurate hemoglobin determinations can be achieved by
using reference (manual) methods and a plasma blank.
• Increased turbidity may also be seen in cases where the red blood cells are resistant to lysing.
This condition will cause an incorrect high Hgb result, but may be detected by observing the
abnormal MCH, MCHC values, and the increased baseline on the leading edge of the WBC
histogram. Erroneous hemoglobin results will cause the results of the MCH and MCHC to be
incorrect as well.
• Fetal bloods - The mixing of fetal and maternal bloods may produce a high inaccurate Hgb value.
Hct (Hematocrit):
• Red blood cells agglutination - May produce an inaccurate Hct and MCV values. Red blood cell
agglutination may be detected by observing abnormal MCH and MCHC values, as well as by
examination of the stained blood film In such cases, manual methods may be required to obtain an
accurate Hct value
MCV (Mean Corpuscular Volume):
• Red blood cell agglutination - May produce an inaccurate MCV value. Red blood cell
agglutination may be detected by observing abnormal MCH and MCHC values, as well as by
examination of the stained blood film. In such cases, manual methods may be required to obtain an
accurate MCV value.
• Excessive numbers of large platelets and/or the presence of an excessively high WBC count
may interfere with the accurate determination of the MCV value. In such cases, careful examination
of the stained blood film may reveal the error.
MCH (Mean Corpuscular Hemoglobin):
• The MCH is determined according to Hgb value and the RBC count. The limitations listed for the
Hgb and RBC will have an effect on the MCH and may cause inaccurate values.
MCHC (Mean Corpuscular Hemoglobin Concentration):
• The MCHC is determined according to the Hgb and Hct values. The limitations listed for the Hgb
and Hct will have an effect on the MCHC and may cause inaccurate values.
RDW (Red blood cell Distribution Width):
• The red blood cell distribution width is determined according to the RBC count.
• Nutritional deficiency or blood transfusion - May cause high RDW results due to iron and/or
cobalamin and /or folate deficiency.
Plt (Platelets):
• Very small erythrocytes (microcytes), erythrocyte fragments (schizocytes) and WBC fragments
may interfere with the proper counting of platelets and cause elevated Plt counts.
• Agglutinated erythrocytes - May trap platelets, causing an erroneously low platelet count. The
presence of agglutinated erythrocytes may be detected by observation of abnormal MCH and
MCHC values and by careful examination of the stained blood film.
• Giant platelets in excessive numbers - may cause a low inaccurate platelet count as these large
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PENTRA 80 TECHNICAL MANUALRAA022AA
platelets may exceed the upper threshold for the platelet parameter and are not counted.
• Chemotherapy - Cytotoxic and immunosuppressive drugs may increase the fragility of these
cells which may cause low Plt counts. Reference (manual) methods may be necessary to obtain an
accurate platelet count.
• Hemolysis - Hemolysed specimens contain red cell stroma which may increase platelet counts.
• A.C.D. blood - Blood anticoagulated with acid-citrate-dextrose may contain clumped platelet
which could decrease the platelet count.
• Platelet agglutination - Clumped platelets may cause a decreased platelet count and/or a high
WBC count. The specimen should be recollected in sodium citrate anticoagulant to ensure the
anticoagulated character depending on agglutination and reanalyzed only for the platelet count.
The final Plt result must be corrected for the sodium citrate dilution effect. However, these platelet
clumps do trigger flags L1, LL and LL1.
MPV (Mean Platelet Volume):
• Giant platelets that exceed the upper threshold of the Platelet parameter may not be counted as
platelets. Consequently, these larger platelets will not be included in the instrument’s calculation of
Mean Platelet Volume.
• Very small erythrocytes (microcytes), erythrocytic fragments (Schizocytes) and white blood cell
fragments may interfere with the proper counting and sizing of Platelets.
• Agglutinated erythrocytes - May trap Platelets, causing an incorrect MPV result. The presence
of agglutinated erythrocytes may be detected by observation of abnormal MCH and MCHC values
and by careful examination of the stained blood film.
• Chemotherapy - May also affect the sizing of Plts.
Blood samples collected in EDTA will not maintain a stable Mean Platelet Volume. Platelets
collected in EDTA swell depending on the time post-collection and storage temperature.