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: MOH-DCH/CHP-301/2023
Title: SOP for malaria testing using Version: 1
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 16

Ministry of Health
Division of Community Health 1.0
P.O Box 30016– 00100
NAIROBI
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.

Ministry of Health
P.O Box 30016– 00100
NAIROBI
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 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

Ministry of Health
P.O Box 30016– 00100
NAIROBI
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
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

Ministry of Health
P.O Box 30016– 00100
NAIROBI
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

Ministry of Health
P.O Box 30016– 00100
NAIROBI
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

Ministry of Health
MOH Afya Headquarters, Cathedral Rd. 10.0
P.O Box 30016– 00100 10.0
NAIROBI 10.0
SOP No: MOH-DCH/CHP-301/2023 10.0
Title: SOP for malaria testing using Version: 1 10.0
Malaria Rapid Diagnostic Kits (mRDTs) 10.0
10.0
Effective Date: XX December 2023 Supersedes: None 10.0
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. 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
12.1 Repeat the steps in the procedure incase any step was missed.
12.2 Refer to the interpretation chart for test outcomes
13.0 Procedural notes

N/A
14.0 References.
14.1 Kenya Community Health Strategy 2020-2030

Ministry of Health
P.O Box 30016– 00100
NAIROBI
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
P.O Box 30016– 00100
NAIROBI
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
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
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
Labeling of the mRDT
Selecting the appropriate finger and pricking
Selecting the appropriate

puncture site

Ministry of Health
P.O Box 30016– 00100
NAIROBI
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
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
14.9.3 Job aid for Interpretation of Results
Negative Results

Ministry of Health
P.O Box 30016– 00100
NAIROBI
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 16

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 16

Effective Date: XX December 2023 Supersedes: None

7.0 Materials and Equipment

7.1 MRDT kit

Division of Community Health CHP-SOPs Page 3 of 16

Effective Date: XX December 2023 Supersedes: None

7.7 Bench guard or any other appropriate material

8.0 Sample required

9.0 Performance of procedure

9.1 Preparation to perform the mRDTs testing

Division of Community Health CHP-SOPs Page 4 of 16

Effective Date: XX December 2023 Supersedes: None

9.3 Interpretation of Results

Division of Community Health CHP-SOPs Page 5 of 16

Effective Date: XX December 2023 Supersedes: None

9.3.3 No line – invalid test

9.5 Biosafety in Malaria Testing at Community Level

Division of Community Health CHP-SOPs Page 6 of 16

11. Contingency Plan

12.0 : Corrective action

12.2 Refer to the interpretation chart for test outcomes

13.0 Procedural notes

14.1 Kenya Community Health Strategy 2020-2030

Division of Community Health CHP-SOPs Page 7 of 16

Effective Date: XX December 2023 Supersedes: None

14.2 Kenya Malaria Strategy 2019-2023

14.6 Appendix A: Revision History

Superseded Revisions done and/or

None N/A 1. Original document

Division of Community Health CHP-SOPs Page 8 of 16

Effective Date: XX December 2023 Supersedes: None

Total No. of Copies: 4 Distribution date:17-01-2022

Division of Community Health CHP-SOPs Page 9 of 16

Effective Date: XX December 2023 Supersedes: None

Division of Community Health CHP-SOPs Page 10 of 16

Effective Date: XX December 2023 Supersedes: None

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

Division of Community Health CHP-SOPs Page 11 of 16

Effective Date: XX December 2023 Supersedes: None

Labeling of the mRDT

Selecting the appropriate finger and pricking

Selecting the appropriate

Division of Community Health CHP-SOPs Page 12 of 16

Effective Date: XX December 2023 Supersedes: None

Finger Prick Sample Collection

Heel Prick Sample Collection

Collect the right amount of blood into the collecting device

Division of Community Health CHP-SOPs Page 13 of 16