rapid diagnostic testing
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Rapid Diagnostic Testing. MAJ Kris Paolino , MD Infectious Disease Staff Chief, Clinical Trials Center Walter Reed Army Institute of Research. Disclaimer. - PowerPoint PPT PresentationTRANSCRIPT
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Rapid Diagnostic TestingMAJ Kris Paolino, MD
Infectious Disease StaffChief, Clinical Trials Center
Walter Reed Army Institute of Research
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Disclaimer
The views expressed in this presentation are those of the speaker and do not reflect
the official policy of the Department of Army, Department of Defense, or U.S.
Government
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Binax Now rapid malarial test instructional video:
http://www.youtube.com/watch?v=bhsXZXqAw7c
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MalariaThere are several RDTs in the world for malaria testingBinax Now is the one you will see in DoD (FDA-
approved)Takes ~15 minutes to completeDon’t need a microscope for this testSingle reagent usedVery easy to use with minimal training neededWill handle austere environmentsReliability:
False negatives possible due to: Prozone effect, i.e. lots of parasites, and thus too much antigen
available Very early disease with low parasitemia
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MalariaTHIS TEST DOES NOT REPLACE MICROSCOPY AS YOU NEED TO
LOOK AT THE SMEAR TO:
1. Confirm the RDT result2. Determine the species
3. Determine the % parasitemia4. Confirm you don’t have a false negative
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MalariaThere are 3 bands or lines:
C = control bandT1= Plasmodium falciparum (i.e. the “bad”
malaria) Histidine Rich Protein 2 (HRP2) antigen
T2= All malaria species (panmalarial aldolase)
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MalariaInterpretation:
All 3 bands positive either:P. falciparum or Mixed infection (i.e. P. falciparum plus another
species)
C and T1 positive: P. falciparum C and T2 positive: P. vivax, P. ovale, P.
malariaeC only positive: NEGATIVE
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MalariaBinax NOW Malaria
Sensitivity Specificity
P. falciparum 99.7% 94.2%
P. Vivax 93.5% 99.8%
• THESE SENSITIVITY NUMBERS ARE DEPENDENT ON THE PARASITE BURDEN• The lower the parasitemia (early disease) the lower the
sensitivity• P. ovale and P. malariae sensitivity only ~50%
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Missed weak positive
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Need some training as the tech called this “negative” even
though the control band didn’t work correctly
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Breakdown in quality control
(reagent issues?)
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HIVTypically used for point of careMany of the tests now have HIV-1 and 2
capabilityNeeds confirmatory testing for positive
resultsTypically have extremely high sensitivity so if
NEGATIVE the patient is nearly guaranteed to be HIV negative If you suspect an acute HIV infection, the sensitivity
will be much lower (i.e. don’t use to screen acute HIV)
Results are typically available in less than 30 mins
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HIVRDTs available:
OraQuick Advanced Rapid HIV ½ Ab testOraSure HIV-1 Western Blot testUni-gold Recombigen HIV-1 testReveal G-3 Rapid HIV-1 Ab test Multispot HIV -1/HIV-2 Rapid testClearview HIV-1/2 Stat PakVITROS Anti HIV ½ test
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The OraQuik and Uni-Gold products can be stored at room temperatureThe other two need their reagents refrigerated
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OraQuick
In home testing
capability
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OraQuick instructional video:
http://www.youtube.com/watch?v=5FBWORY91J4
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Questions?