STANDARD OPERATING PROCEDURE CONFIDENTIAL

MINISTRY OF HEALTH
Title: Pregnancy Test Strip

Number: Effective date: Pages: 5

KIBAGABAGA HOSPITAL
LABORATORY DEPARTMENT
KBGA-DHL-SOP010Vers01 6/6/2013
Revision date:
6/6/2014
Prepared by : GASANA Paul Authorised and signed by
Director kibagabaga Hospital

History of revision
Number of version Effective date Reason

1. INTRODUCTION

Pregnancy is a physiological state of a woman resulting from the fusion of an ovum from the
woman and a sperm from a man. To confirm early pregnancy, a laboratory test is required and
can be done by the detection of the hCG hormone using a dipstick in the urine or serum of the
patient.

2. DEFINITIONS AND ABBREVIATIONS

 hCG: human Chorionic Gonadotropin

 DHL: District Hospital Laboratory
 PPE: Personal Protective Equipment
 KBGA: Kibagabaga
 SOP: standard operating procedure
 PPE: personal protective equipment
- Pregnancy: The fertilization and development of one or more offspring, known as a fetus
or embryo, in a woman's uterus

3. OBJECTIVE

To elaborate the standard method of performing a pregnancy test in KBGA district laboratory

4. USERS

This SOP is used laboratory technicians in KBGA district hospital.

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5. RESPONSIBILITIES
ACTIVITY RESPONSIBLE PERSON
Ensure that all users have been trained, understand Hospital director
content of this sop and is documented. Laboratory Manager
Ensure that all necessary materials are available and of Laboratory Manager
good quality. laboratory technicians

Ensure the quality of samples. Laboratory Manager

Laboratory technicians
Ensure proper performance of pregnancy test Laboratory Manager
laboratory technicians
Ensure the validation and reporting of results. Laboratory Manager
Laboratory technicians
Discard waste properly Laboratory Manager
laboratory technicians

6. PROCEDURE

Biosafety

Urine and blood specimens may contain infectious agents. Therefore, they must be handled
carefully to prevent accidental transmission of diseases.

6.1 Materials

a. Appropriate PPE
b. Clean container for urine collection
c. Permanent marker
d. cleaning paper
e. Waste bins
f. Blood collection tubes
g. Disinfectant

6.2 Reagents

Pregnancy test strips

6.3 Samples

Urine or blood of the patient.

6.4 Quality Control

a. Check the expiry date of strips

b. Check the storage conditions
c. Use a known positive sample (positive control)
d. Use a known negative sample (negative control)

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6.5 Test Procedure

a. Wear gloves
b. Crosscheck the sample identification and that on the worksheet
c. Open the sample container
d. Open the strip container.
e. Immerse the test strip vertically in the sample container without exceeding the line(red)
indicated.
f. Remove the strip after three seconds and place on a flat non-absorbent surface.
g. Read the result after the time indicated on the kit.
h. Discard used strips in the waste bin
i. Disinfect the bench
j. Decontaminate and discard urine and/ or blood samples

6.6 Interpretation of results

a. Positive result: the appearance of two distinct red lines in the test window (T) and control
(C)
b. Negative result: the appearance of a single red line in the control window (C)
c. Result invalid: no appearance of red line in the control window (C)

7. REFERENCES:

http://www.google.rw/search?hl=en&output=search&sclient=psy-
ab&q=pregnancy+wikipedia&btnK=&rlz=1R2RNTN_enRW334 cfr notes d’immuno-
serologie
RBC/IHDPC-NRL Division. Integrated training module, English version. December 2011

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Signing page
We, staff members of …………………………………………..do hereby certify that we have
read, discussed (where applicable) and understood the content of this SOP KBGA-DHL-
SOP010 Vers01 We commit ourselves to abide by its spirit and shall strive to comply and
make it complied with.
N° Staff Names Staff Signature Date
1
2
3
4
5
6
7
8
9
10
11
12
13

I, …………………………being the head of Lab manager , 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:

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Amendment Page
Date Amendment Amendment Page Section(s) Author
number involved

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