Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
APPROVAL OF SOPs USED IN CHP SCOPE OF WORK AT HOUSEHOLDS’ IN KENYA
Item
1. Author/s
Title
Names
Committee of
Experts (COE)
drawn from MOH at
National and
Counties, JKUAT &
Partners
Affiliate
Institution
Signature
(dd-mm-yyyy)
1. Mr. Alex Mutua
MOH/DFH/DN
CH
2. Mr. Peterson
Wachira
3. Mr. John
Kabuagi
4. Ms. Elizabeth
MOH/DCS
MOH/DFH/D
MP
LWALA
Community
Alliance
5.
2. QA
Review
Expert from MOH
Division of
Community Health
3. Approving Head; Division of
Authority Community Health
1. John Wanyungu
MOH Afya HQ
2. Beth Gikonyo
MOH Afya HQ
Dr. Maureen Kimani
MOH Afya HQ
Division of Community Health CHP-SOPs
Date
Page 1 of 17
Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
1.0 Purpose.
1.1 To describe the procedures for preparing, reading, recording and interpretting results of malaria
rapid Diagnostic tests for patients suspected of malaria.
2.0 Scope.
2.1 This SOP Shall inform CHPs on the procedures for proper blood sample collection using a finger
prick or heel prick, proper procedure for testing using mRDTs and the procedure for proper waste
management.
3.0 Abbreviations.
3.1 mRDTs: Malaria Rapid Diagnostic Test kits
3.2 CHPs: Community Health Promoters
3.3 MIP: Malaria in Pregnancy
3.4 SOP
3.5 N/A
4.0 Definition of terms
4.1 Uncomplicated malaria:
4.2 Severe malaria:
5.0 Responsibilities.
5.1 This SOP applies to all CHP personnel implementing promotive and preventive healthcare at
household level
5.2 It is the responsibility of CHP to ensure that they read, understand, attest to SOPs and consistently
follow the policies and procedures as described herein.
5.3 The CHO/CHA implementing the community health strategy including support supervisory,
mentorship and coaching of CHP.
6.0 Principle
6.1 mRDTs are simple malaria testing devices that detect the presence of malaria parasites in blood. The
test contains a chemical that reacts with blood. It has two lines, the control line and a test line. If
Division of Community Health CHP-SOPs
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Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
malaria parasites are present, the two lines appear, a control and a positive line. In the absence of
malaria parasites, only the control line will appear.
7.0 Materials and Equipment
7.1 MRDT kit
7.1.1 One Sterile lancets for piercing the finger
7.1.2 Alcohol swab
7.1.3 One Blood collection device
7.1.4 One mRDT cassette
7.1.5 One Buffer solution in bottle
7.1.6 Instructions for the test
7.1.7 One Silica gel to keep the kit dry
7.2 Non sterile gloves
7.3 Dry cotton wool or cotton gauze
7.4 Marker pens
7.5 Timer
7.6 CHP Biosafety Kit
7.7 Bench guard or any other appropriate material
7.8 Disinfectants
7.9 Smartphone for eCHIS or CHP Daily Activity Register
8.0 Sample required
8.1 Blood
9.0 Performance of procedure
9.1 Preparation to perform the mRDTs testing
9.1.1 Identify a suitable area to perform the testing
9.1.2 Gather the necessary materials in the testing area
9.1.3 Check the expiry date at the back of the test package
Division of Community Health CHP-SOPs
Page 3 of 17
Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
9.1.4 Ensure the mRDT packaging is NOT damaged by squeezing gently and listen for gushing air
9.2 Test procedure
9.2.1 Perform ONLY one mRDT at a time
9.2.2 Explain to the patient the procedure you are about to perform
9.2.3 Record patient details on cassette and in the treatment register
9.2.4 Wash and dry your hands, put on gloves on both hands before you start the test
9.2.5 Ask if the patient is left or right-handed then choose the hand less used by the patient
9.2.6 Swab and prick the third or fourth finger of the less used hand
9.2.7 For children aged 2 to 6 months use the heel for sample collection.
9.2.8 Heel Prick is also recommended for malnourished children whose fingers are very thin
9.2.9 Discard the used lancet in a safety box immediately after use
9.2.10 Apply gentle pressure and express the first drop of blood on the fingertip/heel
9.2.11 Wipe it away with a dry piece of cotton wool and express a second drop of blood
9.2.12 Collect the required amount using the blood collecting device
9.2.13 Transfer the collected blood into the sample well of the testing cassette
9.2.14 Add the required drops of buffer solution into the buffer well (check with the manufacturer’s
instructions /leaflet for the right number of drops)
9.2.15 Time the test immediately for the duration stated by the manufacturer e.g. 20 minutes.
9.2.16 Indicate the end time of the test on the cassette
9.2.17 Read results after the recommended time according to the manufactures’ instructions
9.2.18 Manage waste as per the biosafety and IPC guidelines
9.2.19 Record the results on the eCHIS and Community Unit Daily Activity Register (MOH 648)
9.3 Interpretation of Results
9.3.1 One red line (control) – negative
9.3.2 Two red line (Control and Test) – positive
Division of Community Health CHP-SOPs
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Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
9.3.3 No line – invalid test
9.3.4 More than two lines – invalid test
9.4 Precautions
9.4.1 Store and use mRDT kit as per manufacturer’s instructions
9.4.2 Don’t transport mRDTs exposed to direct sunlight
9.5 Biosafety in Malaria Testing at Community Level
Infection prevention and control measures in the community:
9.5.1 Observe hand hygiene according to SOP no. xxxxxxx
9.5.2 Use personal protective equipment (PPE) according to SOP no. xxxxxxx
9.5.3 Prevent needlestick and injuries from other sharp instruments
9.5.4 Observe respiratory hygiene and cough etiquette
9.5.5 Maintain environmental cleanliness by ensuring all surfaces used are cleaned and disinfected.
9.5.6 Manage medical waste appropriately:
a. Management of Biosafety kit: The infectious medical waste generated by CHPs in the
households shall be stored and transported using a specially designed CHPs Biohazard Kit
b. Once the waste container is received at the link health facility, the CHP will be provided with
a replacement biohazard sharps container and a new plastic waste disposal bag (bin liner) to
place in the safe waste container
10.0
Amendments/changes to documents
10.1
This SOP shall be reviewed every two years or when need arises to make sure that they are
up to date and reflects current practice.
Division of Community Health CHP-SOPs
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Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
11. Contingency Plan
11.1.Carry extra mRDT in the unlikely event that you may need to repeat a test
11.2.Repeat test in case the test lines don’t develop after the testing time elapse
11.3.For MIP, severe malaria and children under 2 months old refer to link facility
12.0 : Corrective action
12.1Repeat the steps in the procedure incase any step was missed.
12.2Refer to the interpretation chart for test outcomes
13.0Procedural notes
N/A
14.0References.
14.1Kenya Community Health Strategy 2020-2030
14.2 Kenya Malaria Strategy 2019-2023
14.3 Parasitological guidelines of malaria diagnosis 2020
14.4 Community case management strategy 2020
14.5 National guidelines for Diagnosis, Treatment and Prevention of Malaria in Kenya 6th Edition
Appendices
14.6 Appendix A: Document change history.
14.7 Appendix B: SOP Distribution log.
14.8 Appendix C: SOP Training Attestation Log.
14.9Appendix E: mRDTs job aid
14.6 Appendix A: Revision History
Division of Community Health CHP-SOPs
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Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
Superseded
Version
number
Review date;
None
N/A
(DD-MM-YYYY)
Revisions done and/or
nature of changes and
reason/s or rationale for
change
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
Reviewer’s
name
QA Review
1. Original document
1. N/A
Division of Community Health CHP-SOPs
Page 7 of 17
Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
14.7 Appendix B: Distribution
Total No. of Copies: 4
Location
Distribution date:17-01-2022
No.
copies
of Type of copies:
Hard copy
Soft copy
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
Division of Community Health CHP-SOPs
Page 8 of 17
Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
14.8 Appendix C
SOP attestation after training and orientation on both supervisory and community health promoters’ scope of
work that embodies this Standard Operating Procedure that shall ensure that all safety PPE use are guided by
this document. Attesting that you have been taken through the SOP and you understand the utilization and
compliance by signing as evidence of acceptance.
S/No. Official Names of
CHP
CHP
Identification
No.
Date of SOP
Date of reading and
Training/Orientation proof of compliance
the SOP
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Division of Community Health CHP-SOPs
Page 9 of 17
Signature
Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
14.9 Appendix E: mRDTs Procedure Job Aid
14.9.1 Sample mRDT kit
Division of Community Health CHP-SOPs
Page 10 of 17
Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
14.9.2 Job aids for test procedure
1. Setting up contents for testing for malaria
Division of Community Health CHP-SOPs
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Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
2. Labeling of the mRDT
3. Selecting the appropriate finger and pricking
Division of Community Health CHP-SOPs
Page 12 of 17
Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
4. Selecting the appropriate puncture site
5. Finger Prick Sample Collection
Division of Community Health CHP-SOPs
Page 13 of 17
Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
6. Heel Prick Sample Collection
7. Collect the right amount of blood into the collecting device
Division of Community Health CHP-SOPs
Page 14 of 17
Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
8. Transfer collected blood into the sample well
Add required amount of blood in the small well as shown in the photo above
9. Add the required amount of buffer into the buffer well
Add required amount of buffer in the bigger well as shown in the photo above and wait for
the duration provided in the manufacturers instructions.
Division of Community Health CHP-SOPs
Page 15 of 17
Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
10. Job aid for Interpretation of Results
Negative Results
Positive Results
Division of Community Health CHP-SOPs
Page 16 of 17
Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
Title: SOP for malaria testing using
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023
SOP No: MOH-DCH/CHP-301/2023
Version: 1
Supersedes: None
Invalid Results
11. Job aid for Biosafety Kit
Division of Community Health CHP-SOPs
Page 17 of 17