STANDARD OPERATING PROCEDURE CONFIDENTIAL

MINISTRY OF HEALTH, Title : The use of Humalyzer 3500 Instrument

Number: KBGA-DHL- Effective Date: Revision Date: Pages: 7
SOP012Vers01 20/01/2014 15/12/2014

KIBAGABAGA HOSPITAL Prepared and signed by : Authorised and signed by: Director of
LABORATORY GASANA Paul Kibagabaga hospital
DEPARTMENT

Revision History
Revised by Version number Effective date Description of change

1. PURPOSE

This SOP is aimed to provide guideline in order to ensure the quality of Clinical biochemistry results using
Humalyzer 3500 instrument and using it properly.

2. DEFINITIONS & ABBREVIATIONS

Humalyzer 3500: It is a semi- automated, programmable photometer intended for In Vitro Diagnostic use
by qualified laboratory staff only.
ARV: Antiretroviral (drug)
QC: Quality Control
RBC: Rwanda Biomedical Center
IHDPC: Institute of HIV/AIDS Disease Prevention and Control
NRL: National Reference Laboratory

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3. SCOPE

This SOP applies to all laboratory staff that perform clinical biochemistry tests using Human reagents or
other manufacturer for Humalyzer 3500 instrument. This document should also be read by all staff
implicated in the monitoring of patients on ARVs drugs.

4. RESPONSIBILITY

Responsibilities have been assigned as follows:

Task Person responsable

Ensure that all relevant people have read Director of Clinical Pathology Unit
this SOP, are trained accordingly and that Clinical biochemistry and hematology In-charge
this is documented appropriately
Conduct the preparation of samples Laboratory biotechnologists
Ensure adequate stock of reagents and Clinical biochemistry and hematology In-charge
needed consumables
Ensure that all procedures are performed Clinical biochemistry and hematology In-charge,
according to the SOP Laboratory biotechnologists
Ensure validation, recording and reporting Director of Clinical Pathology Unit
of results Clinical biochemistry and hematology In-charge
Ensure that the lab staff are applying Clinical biochemistry and hematology In-charge
efficiently the Universal Precautions in the
laboratory

5.EQUIPMENT AND SUPPLIES

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5.2 Supplies
-Reagents
5.1 Equipments
- Roll of thermal paper
-Electrical Centrifuges
-Touch stylus
-Pipette 100-1000µl, adjustable pipette
-Fuse 2A
-Pipette 10-50 µl adjustable pipette
-Main cable
- Pipette 20-100 µl adjustable pipette
-User manual
-Humalzer 3500 analyzer
-Waste tank
-UPS
-Water bath

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6. PROCEDURES

6.1. SPECIAL SAFETY PRECAUTIONS

6.1.1. The instrument should be located in a clean environment, placed on a stable surface and away
from direct sun light which could affect the operating temperature and the quantity of light measured by
the instrument.
6.1.2 Ensure that it is on a level surface.
6.2.3. Avoid positions subject to jerks or vibrations.
6.2.4. Make sure that the instrument is not placed close to air conditioning or heat sources
6.2.5. Avoid excessive dust.

6.2. SAMPLE ANALYSIS PROCEDURES

6.2.1. Starting up the Humalyzer 3500 analyzer

6.2.1.1 Start up the instrument from the main power switch located on the rear side of the instrument.
6.2.1.2. User name screen, enter the operator code by the internal or external keyboard then press SAVE
button. Now the software will proceed to main menu.
6.2.1.3 , To skip this option and proceed to main menu just press EXIT.
6.2.1.4 The main menu is composed of 6 options (Run method, Archives Management, Set up, Utility,
Printing, and Washing) which can be selected by scrolling over the messages.

6.2.2. Servicing the Humalyzer 3500 analyzer

6.2.2.1 After each session of measurements, it is recommended that to wash the flow cell with distilled
water and washing is possible every time: within the MAIN menu, within the RUN mode, within
the ABS mode.
6.2.2.2 For washing the flow cell press the Wash button so the pump will drain away the water at high
speed into the flowcell.
6.2.2.3 After the washing, it is necessary to repeat the operation without water so that the water
remaining inside the instrument can be expelled completely

6.2.3. .3Controlling the Humalyzer 3500 analyzer

6.2.3.1 Reconstitute the controls by adding indicated volume of distilled water or deionized water and
once the controls are reconstituted, they are kept in freezer of minus twenty(-20oC) and must be
put out of freezer for 5 minutes to reach room temperature before controlling.
6.2.3.2 From Main screen press Run Method message, the list of all tests present in memory will be
visualized.
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6.2.3.3 Use the page Up and page Down buttons to scroll the test list.
6.2.3.4 Use the up and down arrow buttons to select the test to be run, once the test is highlighted press
enter button.
6.2.3.5 Once the method is loaded, its parameter will be automatically printed. Controls are read like the
programmed tests.
6.2.3.6 If controls are not within their acceptable units disregard the test results and rerun once again.

6.2.4. Running the samples

6.2.4.1. Prepare samples

6.2.4.2. On first screen: User name screen, enter the operator code then press Save button
6.2.4.3. On second screen: password screen, enter the password code then press Save button
6.2.4.4. From Main screen press Run method message, the list of all tests present in memory will be
visualized.
6.2.4.5. Select test to be run
6.2.4.6. Click on Enter arrow or click on the test you want to run
6.2.4.7. Once the method is loaded, its parameter will be automatically printed
6.2.4.8. Prepare the reagents and samples following Manufacturer’s test kits
6.2.4.9. The blank is performed each time the absorbance zero is required from method parameter:
6.2.4.10. When the water or the reagent blank is chosen, the zero protocol is performed only once, at the
beginning of the running method.
6.2.4.11. Before pressing the PUSH button, after every standard, control or sample measurement, it is
necessary to fill the flow cell with zero solution again, after this operation it is possible to proceed to a
new standard or sample measurement.
6.2.4.12. To run the program, set up the test tube with the sample and press PUSH button
6.2.4.13. The instrument will fill the flow cell, take a measurement, and the expel the sample
6.2.4.14. Then the results will be printed out.

6.4. Maintenance

For maintenance of the Humalyzer 3500, refer to the user manual.

6.5. References

6.5.1. Humalyzer 3500 User Manual

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Signing page
We, staff members of Kibagabaga DHL do hereby certify that we have read, discussed (where
applicable) and understood the content of this SOP no KBGA-DHL-SOP012Vers01
We commit ourselves to abide by its spirit and shall strive to comply and make it complied with.

N° Staff Names Staff Signature Date

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10

11

12

13

14

15

I, …………………………………..…………………………..…being the lab manager of Kibagabaga

DHL, do hereby certify that all the staff, as listed above, have read, discussed and understood the SOP as
indicated herein.
Name and signature of head of LAB Date:
Amendement Page

Date Amendment Amendment Page Section(s) Author

number involved

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