RDT Performance issues Index: Difference between revisions
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{| class="wikitable" style="widthe:90%; border-style: solid; border-width: 4px; border-color:teal" | {| class="wikitable" style="widthe:90%; border-style: solid; border-width: 4px; border-color:teal" | ||
|colspan="1" style = "font-size:140%; color:black; background: FFFAFA"|<span style="color:black>''' | |colspan="1" style = "font-size:140%; color:black; background: FFFAFA"|<span style="color:black>'''Causes for poor performance of RDT tests'''</span> | ||
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<span style="font-size:90%">'''1. Selection and procurement of MDTs'''</br> | <span style="font-size:90%">'''1. Selection and procurement of MDTs'''</br> | ||
<span style="font-size:90%">(a) Quality of test design/production. Historically there was significant variation of performance between tests and batches, this has been greatly improved with the WHO pre-qualification testing program that requires a minimum standard of performant, however users are still advised to check the performance of their selected test (see WHO testing information ref 2 above)</br>(b) Lot variability. Variability between different production batches has been observed and should be considered if RDT performance is less good than expected.</br> | <span style="font-size:90%">(a) Quality of test design/production. Historically there was significant variation of performance between tests and batches, this has been greatly improved with the WHO pre-qualification testing program that requires a minimum standard of performant, however users are still advised to check the performance of their selected test (see WHO testing information ref 2 above)</br>(b) Lot variability. Variability between different production batches has been observed and should be considered if RDT performance is less good than expected.</br></br> | ||
<span style="font-size:90%">'''2. Stability and storage issues'''</br> | <span style="font-size:90%">'''2. Stability and storage issues'''</br> | ||
<span style="font-size:90%">(a) RDTs typically have a shelf-life of 18–24 months providing storage is appropriate.</br>(b) Tests can suffer degradation if stored in inappropriate heat or humidity: generally tests are stable in the range 2–30°C or higher, but these limits may be exceeded in many countries, and continuous product refrigeration to the point of use may not be guaranteed in developing countries. | <span style="font-size:90%">(a) RDTs typically have a shelf-life of 18–24 months providing storage is appropriate.</br>(b) Tests can suffer degradation if stored in inappropriate heat or humidity: generally tests are stable in the range 2–30°C or higher, but these limits may be exceeded in many countries, and continuous product refrigeration to the point of use may not be guaranteed in developing countries.</br></br> | ||
<span style="font-size:90%">'''3. Operator training'''</br> | <span style="font-size:90%">'''3. Operator training'''</br> | ||
<span style="font-size:90%">(a)Problems in test usage may include inappropriate placement of test reagents or blood sample on RDT.</br>(b)Poor interpretation of faint lines.</br>(c) Inadequate training or reference materials | <span style="font-size:90%">(a)Problems in test usage may include inappropriate placement of test reagents or blood sample on RDT.</br>(b)Poor interpretation of faint lines.</br>(c) Inadequate training or reference materials | ||
Revision as of 17:57, 5 December 2024
| Causes for poor performance of RDT tests
1. Selection and procurement of MDTs (a) Quality of test design/production. Historically there was significant variation of performance between tests and batches, this has been greatly improved with the WHO pre-qualification testing program that requires a minimum standard of performant, however users are still advised to check the performance of their selected test (see WHO testing information ref 2 above) 2. Stability and storage issues (a) RDTs typically have a shelf-life of 18–24 months providing storage is appropriate. 3. Operator training (a)Problems in test usage may include inappropriate placement of test reagents or blood sample on RDT. |