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. 2024 Nov 26;112(4 Suppl):99–108. doi: 10.4269/ajtmh.23-0898

Table 2.

Finding of the audit performed on the SRAS-CoV-2 Ag-RDT flow at the Littoral fan zone’s testing point discrepancies between reverse transcription polymerase chain reaction and Ag-RDT results

Domain Item Assessed Method, Mean, Source of Verification Summary of Findings Conclusion
Testing capacities, logistics, and biosafety at the fan zone Personnel (quality and quantity) Checking the listing and attendance registers 32 trained staff: 5 senior laboratory technicians, 4 laboratory technicians, 4 assistant laboratory technicians, 7 clinical doctors, 2 pharmacists, and 10 assistants for WASH Appropriate number of staff by cadre available and trained for SARS-CoV-2 Ag-RDT testing
One-on-one and group discussions with manager and staff Regular trainings on testing, case management, drug and vaccine delivery, stock management, and WASH according to each cadre
Settings, logistics and flow Monitoring visit to fan zone testing points during busy periods Dedicated places for 1) triage, 2) registration, 3) sample collection and testing, 4) reading and result validation, 5) negative result announcement, 6) positive result announcement and medical interview, 7) vaccine administration Testing points well organized to avoid confusion and ease the work flow
All these specific places were under tents installed and organized to ease the testing flow Low/medium risk of testing material and personnel exposed to temperature (Temp. >30°)
Absence of air conditioner under the tent, leading to ambient temperatures above 30°C
Security and biosafety Monitoring visit to fan zone testing points during busy periods Availability of protective equipment for personnel and participants (face mask, gloves, overcoat, hand sanitizers) and safety box No evidence of biosafety challenge or risk for contamination
Group discussion with the staff WASH team available with material and strict on the timing for sanitization
Personnel’s practices with SARS-CoV-2 Ag-RDT Checking batch number and expiry date Group discussion with the testing staff Systematically done by the team but not documented in a register as recommended
“Abbott Pan bio” with batch (41ADG627B) was recognized as the only test kit used for the study
No/minimal risk of using expired test kit with this batch number of “Abbott Pan bio”
Performing quality control on each box before starting using the kits This was not systematically done by the team and also not documented when done Medium/considerable risk of using invalid test kits that should be removed from the stock
Unexpected results during quality control observed with two boxes (negative control showed positive results), but this was not documented and the team unable to provide these boxes
Mastering manufacturer SOP for the use of the test kit No job aid displayed or easily accessible to remind the staff on the procedure Low/medium risk of invalid results failure to follow manufacturer (pan bio) SOPs when using the test kit
Discrepancies in the answers about the number of drops necessary during the test (3 for some staff instead of 5 as recommended)
Answers on the knowledge consistent with answers on the practices
Lack of chronometers at the reading and validation point, and variability in reading time (15 minutes or less for some staff and 20 minutes for others)
Use of the buffer fluid from one box to perform test with kits from another box

Ag-RDT = antigen rapid diagnostic test; SOP = standard operating procedure; WASH = water, sanitation and hygiene.