Quality Assurance Package for TB Lateral Flow LAM (LF-LAM) Testing
The Quality Assurance Package for TB Lateral Flow LAM (LF-LAM) Testing was developed by the African Field Epidemiology Network and the U.S. Centers for Disease Control and Prevention (CDC), with funding from the United States President’s Emergency Plan for AIDS Relief (PEPFAR).
This Package provides practical considerations, documents, and tools to establish, implement, monitor, and continuously improve quality assurance (QA) systems for TB LF-LAM testing at all levels of disease control programmes. It is intended to inform Ministry of Health officials, National TB and HIV Programme officials, National TB and HIV Reference Laboratory personnel, laboratory-based and non-laboratory testers, healthcare workers involved in LF-LAM programmes, and other key stakeholders on the how to implement activities to assure the quality of LF-LAM testing systems. The Package includes a User Guide, as well as customizable and standardized operating procedures for testing, new method validation, and quality control material development, forms to document quality practices and results, training and competency assessment for various cadres of stakeholders, and automated Excel-based tools for LF-LAM testing site readiness and quality assessment as well as performance, indicator, and cascade impact monitoring at the site and above-site levels
Download User guide Download Training Material
Download Forms
- Form_F1_LF-LAM Tester Database.xls
- Form_F2_Test Result Log
- Form_F3_Training and Competency Assessment Checklist_Tester
- Form_F4_Training and Competency Assessment Checklist_Training of Trainer
- Form_F5_M&E Tool with Automated Analyses-clean
- Form_F6_SPI-RT for LF-LAM Site Readiness & Quality Assurance Checklist
Download Procedures
- Procedure_P1_Abbott Determine TB-LAM Ag Method Validation-clean
- Procedure_P2_Mentor4TB LF-LAM Testing Procedure
- Procedure_P3_Urine Collection and Storage for LF-LAM Quality Control
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