Bioline TM

MALARIA Ag
RDT SERIES
Rapid and Accurate Malaria Diagnostic Tests
for Effective Malaria Case Management
 Portfolio of
Bioline Malaria RDTs TM

for Detection
of Malaria Antigens

EASY TO USE

1 Add Specimen
Dispense 5μl of whole blood
into the round specimen well.
INVERTED CUP
2 Add Assay Diluent
Dispense 4 drops of assay
diluent into the square assay
diluent well.
3 Wait 15 mins.
Interpret test results in
15 minutes.
Caution : Do not read after 30
CAPILLARY PIPETTE# ASSAY minutes. Reading outside of
DILUENT this time frame may provide
false results.

OR
C P.v P.f C P.v P.f C P.v P.f 15
MIN
MALARIA

MALARIA

MALARIA
P.f/P.v

P.f/P.v

P.f/P.v

Consult the Instructions for use supplied with the kit for complete information. #Capillary pipette not available for 05FK120

Bioline Malaria Ag P.f/Pan TM

n Cat. No. : 05FK60, 05FK63

n Detection : P.f-HRP2 and Pan-pLDH
n Useful in regions where all malaria species are circulating
n WHO prequalified

PERFORMANCE

DETECTION SENSITIVITY SPECIFICITY

P.f (HRP2) 99.7% 99.5%

Pan (pLDH) 95.5% 99.5%

Bioline Malaria Ag P.f/P.v
TM

n Cat. No. : 05FK80

n Detection : P.f-HRP2 and P.v-pLDH
n Differential detection of P.f and P.v
n Useful in regions where P.v and P.f are both dominant
n Differentiate P.f mono infection from P.f/P.v co-infection
n WHO prequalified

PERFORMANCE

DETECTION SENSITIVITY SPECIFICITY

P.f (HRP2) 99.7% 99.5%

P.v (pLDH) 95.5% 99.5%

Bioline Malaria Ag P.f/P.f/P.v

TM

n Cat. No. : 05FK120

n Detection : P.f-HRP2, P.f-pLDH and P.v-pLDH
n Differential detection of P.f and P.v
n Useful in regions where P.v and P.f are both dominant
n Useful in regions where gene deletion is suspected
n Differentiate P.f mono infection from P.f/P.v co-infection
n WHO prequalified

PERFORMANCE

DETECTION SENSITIVITY SPECIFICITY

P.f (HRP2) 99.7% 99.3%

P.f (pLDH) 97.4% 99.3%

P.v (pLDH) 95.5% 99.3%

Bioline Malaria Ag P.f TM

n Cat. No. : 05FK50

n Detection : P. falciparum-HRP2
n Specific and accurate diagnosis for P. falciparum
n WHO prequalified

PERFORMANCE

DETECTION SENSITIVITY SPECIFICITY

P.f (HRP2) 99.7% 99.5%

Consult the Instructions for use contained in the kit for detailed performance data.
Bioline Malaria Ag RDT Series
TM

ORDERING INFORMATION

PRODUCT CAT. NO. DESCRIPTION (TARGET ANTIGEN) SPECIMEN TYPE NO. TESTS

05FK60 Whole blood Device 25T

Detects all species (pan) and distinguishes
Bioline TM

infection with P.f

Malaria Ag P.f/Pan
(P.f-HRP2 and Pan-pLDH)
05FK63 Whole blood Device 1T x 25*

Bioline TM
Differential detection of P.f and P.v
05FK80 Whole blood Device 25T
Malaria Ag P.f/P.v (P.f-HRP2 and P.v-pLDH)

Bioline TM
Differential detection of P.f and P.v
05FK120 Whole blood Device 25T
Malaria Ag P.f/P.f/P.v† (P.f-HRP2, P.f-pLDH and P.v-pLDH)

Bioline TM

05FK50 Detection of P.f (P.f-HRP2) Whole blood Device 25T

Malaria Ag P.f

Single use
Bioline TM
Positive & Negative Control for select
05FK10C QC (1x Pos & 1 x Neg
Malaria Control Kit˄ Bioline Malaria Antigen Tests˄
Control Swab)

* Bioline Malaria Ag P.f/Pan 05FK63 contains 25 test pouches each containing a test device, assay diluent, disposable sample applicator, instructions for use, lancet and alcohol swab.
TM

† Investigational use only in Australia

˄
Compatible with 05FK60, 05FK63, 05FK80, 05FK50

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