MRDTS SOP - Kyaka Ver.1

Ministry of Health
Division of Community Health

MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
SOP No: 402
Title: SOP for malaria testing using Version: MOH-DCH-402/2023
Malaria Rapid Diagnostic Kits (mRDTs)
Effective Date: XX December 2023 Supersedes: None
APPROVAL OF SOPs USED IN CHP SCOPE OF WORK AT HOUSEHOLDS’ IN KENYA
Item Title Names Affiliate Signature Date

Institution (dd-mm-yyyy)
1. Author/s Committee of 1. Mr. Alex Mutua MOH/DFH/

Experts (COE) DNCH
drawn from MOH at
National and 2. Mr. Peterson MOH/DCS
Counties, JKUAT & Wachira
Partners 3. Mr. John MOH/DFH/
Kabuagi DMP
4. Ms. Elizabeth LWALA
Community
Alliance
5.
2. QA Expert from MOH 1. John Wanyungu MOH Afya HQ

Review Division of
2. Beth Gikonyo MOH Afya HQ
Community Health
3. Approving Head; Division of Dr. Maureen Kimani MOH Afya HQ
Authority Community Health
Division of Community Health CHP-SOPs Page 1 of 17

Ministry of Health
P.O Box 30016– 00100 1.0
NAIROBI
SOP No: 402
Purpose.
1.1 To describe the procedures for preparing, reading and recording results of malaria rapid Diagnostic
tests for patients suspected of uncomplicated malaria infection.
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
4.0 Definition of terms

4.1 . N/A
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.

Ministry of Health
P.O Box 30016– 00100
NAIROBI
SOP No: 402
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 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 One Sterile lancets for piercing the finger
7.2 Alcohol swab
7.3 One Blood collection device
7.4 One mRDT cassette
7.5 One Buffer solution in bottle
7.6 Instructions for the test
7.7 One Silica gel to keep the kit dry
Additional materials for mRDT testing
7.8 Non sterile gloves

7.9 Dry cotton wool or cotton gauze
7.10 Marker pens
7.11 Timer

Ministry of Health
P.O Box 30016– 00100
NAIROBI
SOP No: 402
7.12 CHV Biosafety Kit

7.13 Bench guard
7.14 Disinfectants
7.15 CHV Daily Activity Register
7.16 Printer and toners
7.17 Rim papers
7.18 Pen and ink
8.0 Sample required

8.1 Peripheral blood
9.0 Performance of procedure
9.1 Preparation to perform the mRDTs testing
● Identify a suitable area to perform the testing
● Gather the necessary materials in the testing area
● Check the expiry date at the back of the test package

Ministry of Health
P.O Box 30016– 00100
NAIROBI
SOP No: 402
● ● Ensure the mRDT packaging is NOT damaged by squeezing gently and feel
9.2 Test procedure
● Perform ONLY one mRDT at a time
● Explain to the patient the procedure you are about to perform
● Record patient details on cassette and in the treatment register
● Wash and dry your hands, put on gloves on both hands before you start the test
● Ask if the patient is left or right-handed then choose the hand less used by the patient
● Swab and prick the third or fourth finger of the less used hand
● For children aged 2 to 6 months use the heel for sample collection.
● Heel Prick is also recommended for malnourished children whose fingers are very thin
● Apply gentle pressure and express the first drop of blood on the fingertip/heel
● Wipe it away with a dry piece of cotton wool and express a second drop of blood

Ministry of Health
P.O Box 30016– 00100
NAIROBI
SOP No: 402
● ● Collect the required amount using the blood collecting device
● Transfer the collected blood into the sample well of the testing cassette
● Add the required drops of buffer solution into the buffer well (check with the manufacturer’s
instructions /leaflet for the right number of drops)
● Time the test immediately for the duration stated by the manufacturer e.g. 20 minutes.
● Indicate the end time of the test on the cassette
● Read results after the recommended time according to the manufactures’ instructions
● Manage waste as per the biosafety guidelines
● Record the results on the Community Unit Daily Activity Register (MOH 648)
9.3 Interpretation of Results
● One red line (control) – negative
● Two red line (Control and Test) – positive
● No line – invalid test

Ministry of Health
P.O Box 30016– 00100
NAIROBI
SOP No: 402
● ● More than two lines – invalid test
9.4 Precautions
● Keep and store at recommended temperature
● Avoid extreme temperature (very hot or deep freezing)
● Non-humid environment
● 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:
● Hand hygiene
● Use of personal protective equipment (PPE)
● Prevention of needlestick and injuries from other sharp instruments
● Respiratory hygiene and cough etiquette
● Environmental cleaning (Table)

Ministry of Health
P.O Box 30016– 00100
NAIROBI
SOP No: 402
● ● Management of household waste
● Management of Biosafety Kit
● The infectious household waste generated by CHVs shall be stored and transported using a specially
designed CHVs Biohazard Kit
● Once the waste container is received at the link health facility, the CHV 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.
11. Contingency Plan

11.1. Repeat test in case the test lines don’t develop after the testing time elapse
11.2. For MIP, severe malaria and children under 2 months old refer to link facility
12.0 : Corrective action

12.1 Use correct amount of blood
12.2 Use correct amount buffer
12.3 Use correct timing for testing procedure
13.0 Procedural notes

N/A

Ministry of Health
P.O Box 30016– 00100
NAIROBI
SOP No: 402
14.0 References.
14.1 Kenya 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.
14.9 Appendix E: mRDTs job aid
14.6 Appendix A: Revision History
Superseded Revisions done and/or

Review date; nature of changes and Reviewer’s
Version QA Review
(DD-MM-YYYY) reason/s or rationale for name
number change
None N/A 1. Original document
1. N/A

Ministry of Health
Division of Community Health 14.7
P.O Box 30016– 00100
NAIROBI
SOP No: 402
Appendix B: Distribution
Total No. of Copies: 4 Distribution date:17-01-2022

Location No. of Type of copies:
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.

Ministry of Health
14.8 Division of Community Health
P.O Box 30016– 00100
NAIROBI
SOP No: 402
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 Date of SOP Date of reading and Signature
CHP Identification Training/Orientation proof of compliance
No. the SOP
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.

Ministry of Health
P.O Box 30016– 00100 14.9
NAIROBI
SOP No: 402
Appendix E: mRDTs Procedure Job Aid
14.9.1 Sample mRDT kit
14.9.2 Job aids for test procedure
Setting up contents for testing for malaria

Ministry of Health
P.O Box 30016– 00100
NAIROBI
SOP No: 402
Labeling of the mRDT
Selecting the appropriate finger and pricking
Selecting the appropriate

puncture site

Ministry of Health
P.O Box 30016– 00100
NAIROBI
SOP No: 402
Finger Prick Sample Collection
Heel Prick Sample Collection
Collect the right amount of blood into the collecting device

Ministry of Health
P.O Box 30016– 00100
NAIROBI
SOP No: 402
Transfer collected blood into the sample well
Add the required amount of buffer into the buffer well

Ministry of Health
P.O Box 30016– 00100
NAIROBI
SOP No: 402
14.9.3 Job aid for Interpretation of Results
Negative Results

Ministry of Health
P.O Box 30016– 00100
NAIROBI
SOP No: 402
Positive Results
Invalid Results
14.9.4 Job aid for Biosafety Kit

MRDTS SOP - Kyaka Ver.1

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Ministry of Health

Division of Community Health

Effective Date: XX December 2023 Supersedes: None

APPROVAL OF SOPs USED IN CHP SCOPE OF WORK AT HOUSEHOLDS’ IN KENYA

Item Title Names Affiliate Signature Date

1. Author/s Committee of 1. Mr. Alex Mutua MOH/DFH/

2. QA Expert from MOH 1. John Wanyungu MOH Afya HQ

Division of Community Health CHP-SOPs Page 1 of 17

Effective Date: XX December 2023 Supersedes: None

3.1 mRDTs: Malaria Rapid Diagnostic Test kits

4.0 Definition of terms

Division of Community Health CHP-SOPs Page 2 of 17

Effective Date: XX December 2023 Supersedes: None

7.0 Materials and Equipment

Additional materials for mRDT testing

7.8 Non sterile gloves

Division of Community Health CHP-SOPs Page 3 of 17

Effective Date: XX December 2023 Supersedes: None

7.12 CHV Biosafety Kit

8.0 Sample required

9.0 Performance of procedure

9.1 Preparation to perform the mRDTs testing

● Identify a suitable area to perform the testing

● Gather the necessary materials in the testing area

● Check the expiry date at the back of the test package

Division of Community Health CHP-SOPs Page 4 of 17

Effective Date: XX December 2023 Supersedes: None

9.2 Test procedure

● Perform ONLY one mRDT at a time

● Explain to the patient the procedure you are about to perform

● Record patient details on cassette and in the treatment register

Division of Community Health CHP-SOPs Page 5 of 17

Effective Date: XX December 2023 Supersedes: None

● ● Collect the required amount using the blood collecting device

instructions /leaflet for the right number of drops)

● Indicate the end time of the test on the cassette

● Manage waste as per the biosafety guidelines

9.3 Interpretation of Results

● One red line (control) – negative

● Two red line (Control and Test) – positive

● No line – invalid test

Division of Community Health CHP-SOPs Page 6 of 17

Effective Date: XX December 2023 Supersedes: None

● ● More than two lines – invalid test

● Keep and store at recommended temperature

● Avoid extreme temperature (very hot or deep freezing)

● 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:

● Use of personal protective equipment (PPE)

● Prevention of needlestick and injuries from other sharp instruments

● Respiratory hygiene and cough etiquette

● Environmental cleaning (Table)

Division of Community Health CHP-SOPs Page 7 of 17

Effective Date: XX December 2023 Supersedes: None

● ● Management of household waste

● Management of Biosafety Kit

designed CHVs Biohazard Kit

10.0 Amendments/changes to documents

11. Contingency Plan

12.0 : Corrective action

13.0 Procedural notes

Division of Community Health CHP-SOPs Page 8 of 17