Quantitative measurement of G6PD enzyme

activity in just 2 minutes from whole blood sample

• Quantitative Point-of-Care G6PD test
• Measures G6PD & Total Hb simultaneously
• Stable at the temperature expected in tropical settings :
2-40℃ / 36 - 104°F (strip storage temperature)
15~40℃ / 59 - 104°F (measuring temperature)
• Fast and simple test procedure

BACKGROUND*
Primaquine is currently the only medicine for treating relapses of Plasmodium vivax and P. ovale
malaria. The full potential of this medicine to prevent relapses and reduce the transmission of vivax
malaria has however not been fully used, owing to concerns about its safety. The medicine induces
dose-dependent acute haemolytic anaemia in individuals with glucose-6-phosphate dehydrogenase
(G6PD) deficiency, a genetically X-linked disorder. This condition is widely prevalent affecting over 350
million people globally, with a prevalence of 3–35% in tropical areas. Therefore, testing for G6PD defi-
ciency is recommended for safe use of primaquine in this radical cure of P.vivax and P.ovale malaria.
* Reference : Testing for G6PD deficiency for safe use of primaquine in radical cure of P.vivax and P.ovale malaria /WHO

SPECIFICATIONS

Method Colorimetric Measuring time 2minutes

G6PD enzyme activity (U/gHb) 15~40℃ / 59 - 104°F

Measurement Measuring temperature
Total Hemoglobin (g/dL)
Capillary & 2-40℃ / 36 - 104°F
Sample Venous Whole blood Strip storage temperature

Sample volume 5μL CV < 7%

G6PD : 0-20 U/g Hb

Range T-Hb : 7-25 g/dL Size Handheld (6.7 x 13cm)

C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA
TEL: +82-31-300-0400 / FAX: +82-31-300-0499 / E-mail: sales@sdbiosensor.com / Website : www.sdbiosensor.com
TEST PERFORMANCE
• Specimen: Venous whole blood
• Reference: Hitachi 7020-Trinity 345B
• Precision target
- T-Hb : < CV 7%
- G6PD : ± 1.5U/g Hb (<5U/g Hb) / < CV 7% (>5U/g Hb)

T-Hb(g/dL) G6PD (U/g Hb)

RT Reference comparison chart
15 15.4 15.4 15.4 14.9 0.6 3.9 7.6 11.5 15
y =0.9879x + 1.4176
R2 =0.9925
1T 14.2 14.9 15.7 16.3 16.8 0.3 4.2 7.6 10.2 13.5 250.0

SD Biosensor G6PD
2T 13.5 14.4 15.8 16.1 15.8 0.4 4.4 7.9 10.1 15.1 200.0

3T 13.0 16.0 15.7 15.4 16.3 0.6 4.6 7.2 11.0 13.3 150.0

100.0
4T 13.6 14.3 15.6 15.7 15.8 0.5 4.9 2.8 10.4 13.5

50.0
5T 12.8 14.4 15.6 15.0 16.1 0.4 4.8 8.0 11.1 14.6

0.0
Average 13.4 14.8 15.7 15.7 16.2 0.4 4.6 7.7 10.6 14.0
0 50 100 150 200 250
Trinity G6PD 345-B
CV% 4.2 4.7 0.5 3.5 2.6 29.8 6.4 3.8 4.5 5.7

TEST PROCEDURE
1 Insert the test device into the 2 Collect 5uL of Whole blood 3 Mix the sample with the buffer
analyzer

4 Collect 5uL of sample mixture 5 Apply the sample mixture to 6 Test result appears on the
the test device and close the lid screen in 2 minutes

ORDERING INFORMATION
Cat No. Description
02GA10 SD G6PD Analyzer

02GA20 SD G6PD Analyzer (Bluetooth)

02G6S10 SD G6PD Test Device (25ea)