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The FINDER G6PD test is intended for semi-quantitative measurement of glucose-6-phosphate dehydrogenase in venous whole blood specimens collected in lithium heparin tubes, for the identification of G6PD deficient samples. The FINDER G6PD test is intended to be used with the FINDER Instrument in point of care or clinical laboratory settings.

The FINDER G6PD test system measures G6PD quantitatively from a 50uL venous whole blood specimen. The blood specimen should be collected in lithium heparin anticoagulant. The G6PD test system is suitable for use in both a point-of-care setting and a clinical laboratory. The time to result is around 16 minutes from sample introduction. The FINDER G6PD test system consists of the FINDER G6PD Test Cartridge and the FINDER Instrument. The cartridge uses electrowetting-based digital microfluidics to integrate and automate all the sample and reagent handling steps. The instrument contains all the hardware and software required to operate the cartridge, providing electrowetting control, thermal control and detection capability, a touch-screen user interface and software necessary to perform the test and report results.

The SEEKER System, including the SEEKER Instrument and the SEEKER LSD Reagent Kit-IDUA|GAA|GBA|GLA for use on the SEEKER Instrument, is intended for quantitative measurement of the activity of a-L-iduronidase, a-D-glucosidase, Bglucocerebrosidase and a-D-galactosidase A from newborn dried blood spot specimens as an aid in screening newborns for Mucopolysaccharidosis Type I, Pompe, Gaucher and Fabry diseases. Reduced activity of these enzymes may be indicative of these lysosomal storage diseases. The enzymes measured using the SEEKER LSD Reagent Kit-IDUA|GAA|GBA|GLA and their associated lysosomal storage diseases are listed below. | Enzyme (abbreviation) | Disease | |----------------------------|--------------------------------------| | α-L-iduronidase (IDUA) | Mucopolysaccharidosis Type I (MPS I) | | α-D-glucosidase (GAA) | Pompe | | β-glucocerebrosidase (GBA) | Gaucher | | α-D-galactosidase A (GLA) | Fabry |

The SEEKER System employs digital microfluidic technology to measure multiple lysosomal enzymatic activities quantitatively from newborn dried blood spot specimens. The following components are provided: - 1. SEEKER Instrument (including USB and power cables), Desktop PC with monitor, keyboard, mouse, and the Spot Logic software. - 2. SEEKER LSD Reagent Kit IDUA|GAA|GBA|GLA containing enzyme specific substrate reagents, dried blood spot extraction buffer, reaction stop buffer, 4 levels of calibrators and quality control dried blood spots containing 4 levels of quality control (OC) material. Each Reagent Kit contains sufficient consumables for 1440 tests. The contents of the kit are listed below: | Component | Contents | Quantity | |--------------------------------------|---------------------|------------| | Quality control<br>dried blood spots | QC-Base Pool (QCBP) | 1x15 spots | | | QC-Low (QCL) | 1x15 spots | | | QC-Medium (QCM) | 1x15 spots | | | QC-High (QCH) | 1x15 spots | | Enzyme substrates | IDUA | 9x100 µL | | | GAA | 9x100 µL | | | GBA | 9x100 µL | | | GLA | 9x100 µL | | Calibrators | Calibrant A (CALA) | 9x50 µL | | | Calibrant B (CALB) | 9x50 µL | | | Calibrant C (CALC) | 9x50 µL | | | Calibrant D (CALD) | 9x50 µL | Other components needed to run tests include the following: | Component | Contents | Quantity | |----------------|-------------------------|------------------| | Other Reagents | Extraction Buffer (EXT) | 9 x 30 mL | | | Filler Fluid | 9 x 10 mL | | Cartridge | SEEKER cartridge | 1 x 36 | The composition of the enzyme reagents and buffers are summarized below: | Reagent (Description) | Composition | |---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | IDUA<br>(α-L-iduronidase substrate) | 2 mM 4-MU-α-L-iduronide sodium salt<br>3mM D-saccharolactone<br>0.04 M acetate buffer, pH 3.5<br>20 mM methyl β-cyclodextrin<br>0.01% Tween20 | | GAA<br>(α-D-glucosidase substrate) | 5 mM 4-MU-α-glucopyranoside<br>12 µM acarbose<br>0.04 M acetate buffer, pH 3.8<br>20 mM methyl β-cyclodextrin<br>0.01% Tween20 | | GBA<br>(β-glucocerebrosidase substrate) | 16 mM 4-MU-β-glucopyranoside<br>0.05 M/0.1M citrate phosphate buffer, pH 5.2<br>0.01% Tween20<br>1.5% sodium taurocholate | | GLA<br>(α-D-galactosidase A substrate) | 10 mM 4-MU-α-galactopyranoside<br>145 μM N-acetyl galactosamine<br>0.04 M acetate buffer, pH 4.6<br>20 mM methyl β-cyclodextrin<br>0.01% Tween20 | | Stop Buffer STB<br>(reaction stopping buffer) | 0.6 M NaHCO3, pH 11.0 in 0.04% Tween 20 | | Extraction Buffer EXT<br>(dried blood spot extraction buffer) | 0.1% Tween 20 in water | | Filler Fluid<br>(medium for droplet movement) | 0.1% Triton X-15 in 5cSt silicone oil | The Seeker Calibrators are supplied as part of the SEEKER LSD Reagent Kit -IDUA|GAA|GBA|GLA. The calibrators consist of 4 levels of aqueous preparation of 4methylumbelliferone sodium salt (4-MU) in 0.6M sodium bicarbonate buffer, pH 11.0 with 0.01% Tween 20. The concentration of 4-MU in each of the 4 calibrators is indicated in the table below: | Calibrator Level | Concentration of 4-MU | |---------------------|-----------------------| | Calibrant A (CAL A) | 0.0375 µM | | Calibrant B (CAL B) | 0.0750 µM | | Calibrant C (CAL C) | 0.1500 µM | | Calibrant D (CAL D) | 0.3000 µM | The quality control dried blood spots include 4 levels of control material: OC Low (QCL), QC Medium (QCM) and QC High (QCH). The composition of the 4 quality control dried blood spot (DBS) is summarized below. QCBP is used to fill empty wells on a cartridge. | Quality Control Level | Composition | |-----------------------|----------------------------------------------------------------------------------------------------------| | QCBP | Heat inactivated human serum, adjusted to ~50% hematocrit<br>using human red blood cells | | QCL | 5% cord blood and 95% heat inactivated serum, adjusted to<br>~50% hematocrit using human red blood cells | | QCM | 50% cord blood and 50% heat inactivated serum adjusted to<br>~50% hematocrit using human red blood cells | | QCH | Human umbilical cord blood, adjusted to ~50% hematocrit<br>using human red blood cells | The enzymatic activity values for the quality control DBS measured by the manufacturer are given on the lot specific quality control certificate included in each assay kit for all levels except QCBP. Each laboratory should establish its own mean and acceptable ranges for the quality control materials. ### 3. SEEKER Cartridges - 4. Finnipipette Novus 8-channel automatic pipette 1-10 uL - 5. Finnipipette Novus 1-channel automatic pipette 10-100 uL