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Practical reasons for test failure: Difference between revisions

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(Created page with "---- '''Navigation'''</br> Go Back ---- {| class="wikitable" style="widthe:90%; border-style: solid; border-width: 4px; color:black" |colspan="1" style = "font-size:100%; color:blasck; background: FFFAFA"|<span style="color:navy>'''Practical considerations '''</span> <span style="font-size:90%">Bibilography: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4652944/], [https://www.who.int/teams/global-malaria-programme/case-management/d...")
 
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[[Rapid diagnostic tests (RDTs)|Go Back]]
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<span style="font-size:90%">>>>Current page: '''Reasons for Test Failure'''</span>
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{| 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>'''Practical considerations and reasons for test failure'''</span>


{| class="wikitable" style="widthe:90%; border-style: solid; border-width: 4px; color:black"
<span style="font-size:90%">Bibliography: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4652944/], [https://www.who.int/teams/global-malaria-programme/case-management/diagnosis/rapid-diagnostic-tests]</span>
|colspan="1" style = "font-size:100%; color:blasck; background: FFFAFA"|<span style="color:navy>'''Practical considerations '''</span>


<span style="font-size:90%">Bibilography: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4652944/], [https://www.who.int/teams/global-malaria-programme/case-management/diagnosis/rapid-diagnostic-tests]</span>


<span style="font-size:90%">'''1. Selection and procurement of RDTs'''</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. There may be significant variation of performance between tests, users are advised to check test performance (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 than expected.</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 appropriateR.</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 guarenteed 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.


<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 interpretion 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

Latest revision as of 23:04, 17 March 2025

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Practical considerations and reasons for test failure

Bibliography: [1], [2]


1. Selection and procurement of RDTs

(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)
(b) Lot variability. Variability between different production batches has been observed and should be considered if RDT performance is less good than expected.

2. Stability and storage issues

(a) RDTs typically have a shelf-life of 18–24 months providing storage is appropriate.
(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.

3. Operator training

(a) Problems in test usage may include inappropriate placement of test reagents or blood sample on RDT.
(b) Poor interpretation of faint lines.
(c) Inadequate training or reference materials

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