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 Page 2 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 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 Page 4 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 9.3.3 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 Page 5 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 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 Page 6 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 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 Page 11 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 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