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v5 BinaxNOW Malaria Product Insert - US.pdf

v5 BinaxNOW Malaria Product Insert - US.pdf

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Published by pieterinpretoria391
Malaria Binax
Malaria Binax

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Published by: pieterinpretoria391 on Jun 26, 2013
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10/24/2013

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INTENDED USE
The BinaxNOW
®
Malaria Test is an
in vitro 
immunochromatographic assay or the qualitative detection o
Plasmodium 
antigenscirculating in human venous and capillary EDTA whole blood o individuals with signs and symptoms o malarial inection. The test targetsthe histidine-rich protein II (HRPII) antigen specic to
Plasmodium falciparum 
(P..) and a pan-malarial antigen, common to all ourmalaria species capable o inecting humans -
P. falciparum 
,
P. vivax 
(P.v.),
P. ovale 
(P.o.), and
P. malariae 
(P.m.). It is intended toaid in the rapid diagnosis o human malaria inections and to aid in the dierential diagnosis o
Plasmodium falciparum 
(P..) inectionsrom other less virulent malarial inections. Negative results must be conrmed by thin / thick smear microscopy.Clinical perormance has not been adequately established or
P. ovale 
(P.o.) and
P. malariae 
(P.m.). The user must establish perormancecharacteristics o this test with these
Plasmodium 
species.The test is not intended or use in screening asymptomatic populations.
SUMMARY AND EXPLANATION OF THE TEST
Malaria is a major parasitic disease, which is endemic in many countries in various areas o the world. Each year it causes up to 3 milliondeaths and close to 5 billion cases o clinical illness worldwide.
1
 Diagnosis o malaria using traditional microscopy methods can be dicult and requires precise and meticulous microscopy. Thin and thicksmears or malaria detection are labor-intensive and require skilled handling. An experienced technologist is required or interpretation.Even under ideal conditions, microscopic examination o stained blood smears is less than 100% sensitive.The BinaxNOW
®
Malaria Test is a simple, rapid test or the diagnosis o malaria using whole blood collected by nger stick or venousdraw. The dual line ormat allows or detection o malaria parasites and or dierentiation o
Plasmodium falciparum 
(P..) rom otherless virulent malaria species. The test cannot distinguish a single species malaria inection rom a mixed species inection. Good clinicalpractice warrants that microscopy be perormed to make this determination, as well as to dierentiate among the non-alciparum
Plasmodium 
species.It is important that physicians be aware that empiric treatment is required or
P. falciparum 
i signs and symptoms o individuals warrant immediate therapy.
2
Lie threatening end-organ damage can result i treatment is delayed.
PRINCIPLES OF THE PROCEDURE
The BinaxNOW
®
Malaria Test is an immunochromatographic membrane assay that uses monoclonal antibodies to detect 
Plasmodium 
 
falciparum 
antigen and pan-malarial antigen (an antigen shared by all
Plasmodium 
species causing human malaria) in venous andcapillary whole blood specimens. These antibodies, and a control antibody, are immobilized on a membrane support as three distinct linesand are combined with a sample pad, which is impregnated with visualizing particles conjugated to control and anti-malaria antibodies,to create a test strip. This test strip is mounted in a book-shaped, hinged test device, along with wash and absorbent pads, intended toaid in the clearing o the membrane when the device is closed.
Detection of Mixed P.f./P.v. Infection 
Thirty-our samples were both P.. and P.v. positive by microscopy, based on the detection o asexual orms o both species. TheBinaxNOW
®
test detected 32 o these samples by generating both test lines, or a sensitivity o 94.1% (95% CI o 81-98%).
P.. and P.v. Limits o Detection:
In the study described above, BinaxNOW
®
test clinical limit o detection (LOD) or P.., dened as the parasitemia level in inected bloodthat produces positive BinaxNOW
®
test results approximately 95% o the time, was determined to be 1001-1500 parasites per µl andthe clinical LOD or P.v. was determined to be 5001-5500 parasites per µl.
Clinical Sample Perormance - BinaxNOW
®
Malaria Test Sensitivity & Specifcity using Venous Draw andFingerstick Samples – Endemic Population:
The perormance o the BinaxNOW
®
test on both venous draw and ngerstick samples was compared to Giemsa malaria microscopy ina prospective study conducted in 2003 outside the U.S. in a region considered endemic or malaria. Whole blood specimens, collectedby both venipuncture and ngerstick rom 787 patients presenting with malaria-like symptoms, were evaluated on the BinaxNOW
®
 test. Microscopy was considered positive only when asexual malaria orms were detected, since asexual orms (not gametocytes) areindicative o active inection.Samples that were microscopy positive or P.m. or P.o. and those that were a mix o P.. and P.v. by microscopy were excluded rom theanalysis. BinaxNOW
®
test sensitivity and specicity or detection o P.. and P.v. versus microscopy is presented below or the remaining782 samples collected via venipuncture and the remaining 784 samples collected via ngerstick.
BinaxNOW
®
Malaria Test Sensitivity and Specifcity or P.. and P.v. vs. Microscopy in Venous Draw andFingerstick SamplesVenous Draw SamplesFingerstick Samples% Sens95% CI% Spec95% CI% Sens95% CI% Spec95% CIP. .
100%(81/81)96 – 100%94.7%(664/701)93 96%98.8%(82/83)94 – 100%90.4%(634/701)88 – 92%
P.v.
81.6%(102/125)74 – 87%99.7%(655/657)99 – 100%80.6%(104/129)73 87%99.5%(652/655)99 – 100%
Clinical Sample Perormance - BinaxNOW
®
Malaria Test Specifcity – Non-Endemic Population:
The perormance o the BinaxNOW
®
test was compared to Giemsa malaria microscopy in a prospective study conducted in the easternUS in 2006-2007. One hundred (100) whole blood specimens collected rom ebrile patients were evaluated on the BinaxNOW
®
test and on microscopy. All 100 samples were negative or malaria on microscopy, and 99 o these samples generated negative BinaxNOW
®
 test results, yielding a specicity o 99% (99/100) in this low incidence population. BinaxNOW
®
test specicity versus microscopy ispresented below.
BinaxNOW
®
Malaria Test Specifcity vs. Microscopy- / -+ / -% Spec95% CIP..
1000100%96 100%
P.v., P.o., P.m.
99199%95 100%
Analytical Reactivity:
The our species o malaria that inect humans,
Plasmodium falciparum 
(P..),
Plasmodium vivax 
(P.v.),
Plasmodium ovale 
(P.o.)and
Plasmodium malariae 
(P.m.), tested positive in the BinaxNOW
®
Malaria Test at the concentrations listed below.
SpeciesConcentration inParasites per µl Whole Blood
P. alciparum 
310
P. vivax 
50 – 500
P. ovale 
820
P. malariae 
50
Analytical Specifcity (Cross-Reactivity):
To determine the analytical specicity o the BinaxNOW
®
Malaria Test, 28 pathogenic microorganisms (7 bacteria, 5 protists and 16viruses) that may be present in whole blood were tested. All were negative when tested at the concentrations listed below.
TypePathogen TestedConcentration TestedBacteria
Borrelia burgdoreri 
(N40 strain)2.3 x 10
6
organisms/ml
Leptospira interrogans (icterohaemorrhagiae)
1.0 x 10
7
organisms/ml
Leptospira bifexa (andamana)
1.0 x 10
7
organisms/ml
Treponema pallidum 
1.0 x 10
5
organisms/ml
Rickettsia conorii 
(Malish 7)1.0 x 10
7
organisms/ml
Rickettsia typhi 
(Wilmington)1.0 x 10
7
organisms/ml
Orientia tsutsugamushi - Rickettsia 
(Karp)1.0 x 10
7
organisms/ml
Protists
Babesia microti 
(RMNS strain)4.4 x 10
7
parasites/ml
Trypanosoma cruzi 
(Y strain)1.3 x 10
6
parasites/ml
Leishmania donovani 
1.0 x 10
6
parasites/ml
Leishmania inantum 
1.0 x 10
6
parasites/ml
Leishmania chagasi 
1.0 x 10
6
parasites/ml
Viruses
Cytomegalovirus (CMV) (AD169)1.2 x 10
5
PFU/mlEpstein-Barr virus (EBV)1.1 x 10
4
copies/mlDengue virus West Pac 741.2 x 10
5
PFU/mlDengue virus S168033.9 x 10
4
PFU/mlDengue virus CH534891.3 x 10
4
PFU/mlDengue virus TVP3601.4 x 10
5
PFU/mlYellow Fever virus7.9 x 10
6
PFU/mlWest Nile virus1.6 x 10
5
PFU/mlChikungunya virus4.0 x 10
5
PFU/ml
Malaria
Test Kit
Test Kit Product Instructions
1876
© 2012 Alere. All rights reserved.The Alere Logo, Alere and BinaxNOW are trademarks o the Alere group o companies.All trademarks reerenced are trademarks o their respective owners.IN665000 Rev. 5 2012/11Alere Scarborough, Inc.10 Southgate RoadScarborough, Maine 04074 USAwww.alere.com
TypePathogen TestedConcentration TestedViruses
Ross-River virus1.0 x 10
6
PFU/mlInfuenza A Bayern/7/952.5 x 10
7
TCID
50
 /mlInfuenza B Victoria/2/871.0 x 10
7
TCID
50
 /mlHIV-1 (Subtype B)1.4 x 10
5
copies/mlHepatitis B2.0 x 10
5
IU/mlHepatitis C1.9 x 10
5
IU/mlRubella virus>2.0 x 10
2
TCID
50
 /ml
Intererence rom Exogenous Blood Components:
The ollowing substances that may be articially introduced into whole blood were evaluated in the BinaxNOW
®
Malaria Test at theconcentrations listed and were ound not to aect test perormance. Note: The analytical eects o these drugs on the BinaxNOW
®
 test were studied by taking whole blood and spiking it with quantities at high therapeutic concentrations and then testing thesesamples. The eects o the clinical metabolites o these drugs on the test were not studied.
Substance TypeSubstanceConcentration
Anti-malarial drugs(prevention)Mefoquine (Lariam
®
)1 mg/mlDoxycycline* (Vibramycin
®
)1 mg/mlChloroquine1 mg/mlHydroxychloroquine sulate1 mg/mlPaludrine
®
(Proguanil)1 mg/mlPrimaquine1 mg/mlQuinine1 mg/mlSuladoxine andPyrimethamine (Fansidar
®
)1 mg/mlAntibiotic(treatment)Amoxicillin (Trimox
®
)0.1 mg/mlCephalexin0.1 mg/mlCiprofoxacin0.1 mg/mlErythromycin0.1 mg/mlAnti- InfammatoryDrugs (treatment)Aspirin1 mg/mlAcetaminophen1 mg/mlIbuproen (NSAID)1 mg/ml* Doxcycline is also used as an antibiotic, typically at a lower dose than that tested in this study.
Intererence rom Endogenous Blood Components:
The BinaxNOW
®
Malaria Test was evaluated or possible intererence rom high levels o endogenous blood components, based onguidelines described in CLSI EP7. EDTA whole blood samples were tested that contained hemoglobin, protein, bilirubin (conjugatedand unconjugated) or triglycerides at concentrations above physiological levels. None o the endogenous blood components aectedtest perormance.
Intererence rom Unrelated Medical Conditions:
To assess the impact o unrelated medical conditions on the specicity o the BinaxNOW
®
Malaria Test, 116 specimens rom subjectswith a variety o medical conditions unrelated to malaria were tested. Only ve (5) o the 116 specimens tested produced a alse positiveresult on the BinaxNOW
®
Test, our (4) rom subjects known to be positive or rheumatoid actor and one (1) rom a subject with apositive human anti-mouse antibody (HAMA) titer.
Medical ConditionNumber oSamples TestedBinaxNOW
®
TestNegative ResultsBinaxNOW
®
TestPositive Results
Rheumatoid Factor 50464Human Anti-mouse Antibody (HAMA)29281Anti-nuclear Antibody (ANA)30300Systemic Lupus Erythematosus (SLE)770In addition, 20 blood samples, with elevated leukocyte levels ranging rom 24 x 10
6
– 87 x 10
6
white blood cells per ml, wereevaluated in the BinaxNOW
®
Malaria Test and were ound not to aect test perormance.
Reproducibility Study
A blind study o the BinaxNOW
®
Malaria Test was conducted at 3 separate sites using panels o blind coded specimens containingnegative, limit o detection, and low positive P.. and P.v. samples. Participants tested each sample multiple times on 3 dierent days.There was 97% (140/144) agreement with expected test results, with no signicant dierences within run (replicates tested by oneoperator), between run (3 dierent days), between sites (3 sites), or between operators (6 operators). The overall percent detectiono each sample type is summarized below.
Overall Percent Detection o P.. and P.v. SamplesSample Type% Detection
P.. Low Positive94% (17/18)P.. LOD97% (35/36)P.v. Low Positive94% (17/18)P.v. LOD100% (36/36)Negative3% (1/36)** One operator called a negative sample a P.. positive.
REFERENCES
1. Breman, J.G., M.S. Alilio, and A. Mills. Conquering the intolerable burden o malaria: what’s new, what’s needed: a summary.American J. o Tropical Medicine and Hygiene, 2004;71 (Suppl 2):1-15.2. Centers or Disease Control (CDC). Treatment o Malaria (Guidelines or Clinicians), June 28, 2004.3. Manual o Clinical Microbiology, 8th Edition, 2003.
“Plasmodium and Babesia” 
, pp. 1944-59.4. Tjitra, Emiliana, S. Suprianto, J. McBroom, B. J. Currie, and N. M. Anstey. Persistent ICT Malaria P../P.v. Panmalarial and HRP2Antigen Reactivity ater Treatment o
Plasmodium falciparum 
Malaria Is Associated with Gametocytemia and Results in False-Positive Diagnoses o
Plasmodium vivax 
in Convalescence. J. o Clinical Microbiology, March 2001; 39:1025-1031.5. Moody, Anthony. Rapid Diagnostic Tests or Malaria Parasites. Clinical Microbiology Reviews, Jan. 2002; 15: 66-78.6. Iqbal, J., A. Sher, and A. Rab.
Plasmodium falciparum 
Histidine-Rich Protein 2-Based Immunocapture Diagnostic Assay orMalaria: Cross-Reactivity with Rheumatoid Factors. J. o Clinical Microbiology, March 2000; 38:1184-1186.7. Review Criteria or Assessment o Rheumatoid Factor (R)
In Vitro 
Diagnostic Devices Using Enzyme-Linked Immunoassay (EIA),Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate Nephelometry. FDA GuidanceDocument; February 21, 1997.8. Lysenko, A. JA. and A. E. Beljaev. An Analysis o the Geographical Distribution o
Plasmodium ovale 
. World Health OrganizationBulletin, 1969; 40:383-394.9. Collins, W. E., and G. M. Jeery.
Plasmodium ovale 
: Parasite and Disease. Clinical Microbiology Reviews, July 2005; 18:570-581.
ORDERING AND CONTACT INFORMATION
Reorder number:
#: 665-000 BinaxNOW
®
Malaria 12 Test Kit  #: 665-025 BinaxNOW
®
Malaria 25 Test kit  #: 665-010 BinaxNOW
®
Malaria Positive Control Kit US 1 877 441 7440
Technical Support
 
Advice Line
Further inormation can be obtained rom your distributor, or by contacting Alere™ Technical Support on:+ 1 877 866 9341 TS.SCR@alere.com

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