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Carestart g6pd rdt

Manufactured by Access Bio
Sourced in United States

The CareStart™ G6PD RDT is a rapid diagnostic test developed by Access Bio. It is designed to detect the presence of glucose-6-phosphate dehydrogenase (G6PD) enzyme in human blood samples.

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5 protocols using carestart g6pd rdt

1

Qualitative G6PD Activity Assay

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The CareStart G6PD RDT (Access Bio, Korea) was used to analyze G6PD activity qualitatively according to the manufacturer’s procedure. In brief, 10 µl of whole blood sample was added to the sample well, followed by two drops of assay buffer in the buffer well. The result was read in 10 min when a distinct purple colour appeared in the result window indicating normal G6PD, or very faint or no colour indicating G6PD deficiency.
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2

Evaluating G6PD Deficiency with Rapid Tests

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G6PD phenotype was determined using two field-applicable point-of-care tools: the qualitative RDT for G6PD (CareStart™ G6PD RDT; Access Bio, Inc., Somerset, NJ) and quantitative CareStart™ G6PD biosensor (Access Bio, Inc., Somerset, NJ). The RDT for G6PD was performed to screen G6PD deficiency according to the manufacturer’s instructions. This RDT is designed to detect < 30% of normal G6PD activity, but it is most suitable for detecting class I and II G6PD deficiency [26 ], which corresponds to severe G6PD deficiency with < 10% of normal activity, according to the manufacturer. The quantitative G6PD biosensor was used in parallel to measure enzyme activity. Approximately 5 µl of capillary blood was transferred to the strip of the device. The biosensor determines G6PD enzyme activity in 4 min and automatically adjusts the reading to the ambient temperature. In addition to qualitative and quantitative tests for G6PD, haemoglobin level was measured using a portable HemoCue device (HemoCue AB, Ängelholm, Sweden) to normalize G6PD enzyme activity for haemoglobin.
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3

Venous Blood Collection and Quantitative G6PD Assay

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Three millilitres of venous blood were collected into pre-labelled EDTA tubes from each participant, kept in an icebox and transported on the same day to the laboratory of the Military Hospital in Hodeidah city. Data on gender, age, residence, and consanguinity between parents were collected using a pre-designed data collection sheet. Haemoglobin (Hb) concentration was measured using Sysmex KX-21N™ Automated Haematology Analyser (Sysmex Corp, Chuo-Ku, Kobe, Japan).
Qualitative screening for G6PD deficiency was performed on fresh venous blood in the field using CareStart™ G6PD RDT (AccessBio, New Jersey, USA) according to the manufacturer’s instructions. G6PD activity was quantitatively measured within 14 h of blood collection using Randox G-6-PDH kits, Cat No PD2616 (Randox Laboratories Ltd, Antrim, UK) according to the manufacturer’s instructions. The technician who carried out the quantitative enzymatic assay was blinded to the results of the CareStart™ G6PD DT.
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4

Quantitative and Qualitative G6PD Assays

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The G6PD enzyme activity was determined using two quantitative assays (a spectrophotometry assay and a Biosensor assay). The qualitative G6PD test was performed with the CareStart G6PD RDT (Access Bio).
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5

Evaluating CareStart™ G6PD RDT Performance

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The CareStart™ G6PD RDT (Access Bio Inc., New Jersey, USA) was administered concurrently with the malaria RDT on 248 participants at the PHCs as per the manufacturers’ guidelines. Briefly, a finger prick blood sample (2 µl) was collected through the sample pipette, applied into the sample well and 2 drops (~ 100 µl) of assay buffer added. The test was developed at room temperature (25 °C) for 10 min, after which the results were read by two blinded primary evaluators, with a third blind evaluator acting as a tiebreaker to make the final decision in case of discrepancies. Normal G6PD individuals were classified according to the development of a distinct purple coloured test band, while in G6PD-deficient patients, no purple coloured test band developed. A test was declared invalid when either no or incomplete blood migration took place.
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