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see also: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4652944/]


{| class="wikitable" style="border-style: solid; border-width: 4px; color:black"
|colspan="1" style = "font-size:100%; color:black; background: FFFAFA"|<span style="color:navy>'''Possible causes for poor test performance'''</span>


{| 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>


'''Selection and procurement of MDTs'''</br>
<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>
1. Quality of test design/production. There is significant variation of performance between tests, users are advised to check test performance (see WHO testing information available from [https://www.who.int/teams/global-malaria-programme/case-management/diagnosis/rapid-diagnostic-tests].</br>
2. Lot to lot variability. Variability between batches has been observed and should be considered if RDT performance is less than expected.</br>




'''2. Heat stability of the RDT test''' storage</b>
<span style="font-size:90%">'''1. Selection and procurement of MDTs'''</br>
potential for degradation due to heat and humidity. Extended exposure to these conditions can drastically reduce the shelf life of RDTsRDT manufacturers recommend continuous product refrigeration, from the point of manufacture all the way to rural clinics and the point of use. However, in many developing countries, cold-chain continuity cannot be guaranteed. WHO analysis of commercially available malaria RDTs found that 37 out of 50 tests claimed stability ranges of 2–30°C, and that the remaining 13 tests claimed stability up to 40°C. [18] However, in many countries, ambient temperatures regularly exceed these limits.
'''3. Age of test/reagents'''</br>


Operator-Specific Factors
<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>
Operator-Inappropriate placement of reagent or blood drop
 
Operator-Interpreting faint line
<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%">'''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

Latest revision as of 16:05, 6 October 2024

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Practical considerations

Bibilography: [1], [2]


1. Selection and procurement of MDTs

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

2. Stability and storage issues

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

3. Operator training

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

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