The test identifies 25-OH vitamin D in human blood via a fingertip puncture. Credit: StanislavSukhin / Shutterstock.

该测试通过指尖穿刺识别人体血液中的25-OH维生素D。图片来源：StanislavSukhin / Shutterstock。

Health Canada has granted approval for NanoSpeed Diagnostics’ Test4D Serum, designed to identify vitamin D levels in blood serum.

加拿大卫生部已经批准了NanoSpeed Diagnostics公司的Test4D血清测试，该测试旨在检测血清中的维生素D水平。

This development follows the ISO 13485 MDSAP certification of the company’s manufacturing facility in Alberta, Canada, last year, which was said to be crucial in obtaining this regulatory clearance.

这一进展是在去年该公司位于加拿大阿尔伯塔的制造工厂获得ISO 13485 MDSAP认证之后取得的，该认证被认为对获得这一监管批准至关重要。

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The test claims to leverage NanoSpeed’s technology to assess the deficiency of vitamin D both qualitatively and quantitatively.

该测试声称利用NanoSpeed的技术来定性和定量地评估维生素D的缺乏情况。

It is part of the company’s catalogue and was initially introduced in 2013 as the first point-of-care test for this purpose.

它是公司产品目录的一部分，2013年作为首个用于此目的的即时检测产品推出。

Health Canada’s approval adds to the test’s existing CE Mark certification granted by the European Union in 2014.

加拿大卫生部的批准为该测试增添了2014年欧盟授予的CE标志认证。

According to the company, the Vitamin D deficiency is a widespread concern in the country, with 60% of the adult population exhibiting less than optimal levels of 25-hydroxycholecalciferol (25-OH) vitamin D.

据该公司称，维生素D缺乏是该国普遍存在的问题，60%的成年人口表现出低于最佳水平的25-羟基胆钙化醇（25-OH）维生素D。

This deficiency is linked to various health issues, including impaired bone metabolism, cardiovascular conditions, diabetes, and certain cancers.

这种缺乏与多种健康问题有关，包括骨骼代谢受损、心血管疾病、糖尿病和某些癌症。

Traditionally, 25-OH vitamin D levels are measured via lab testing, which has seen a significant increase in demand and associated expenses for government-backed healthcare systems over the past ten years.

传统上，25-OH维生素D水平是通过实验室检测来测量的，过去十年中，这种检测的需求显著增加，给政府支持的医疗系统带来了相关的费用增长。

NanoSpeed CEO Dr Seema Gupta said: “As a company based in Alberta that has sold millions of our tests globally, we are so happy to finally obtain approval to sell our test at home to patients and healthcare practitioners who increasingly recognise the importance that vitamin D sufficiency plays in our everyday health.”.

NanoSpeed首席执行官Seema Gupta博士表示：“作为一家总部位于阿尔伯塔省的公司，我们的检测产品已经在全球销售了数百万份，我们非常高兴最终获得了在本土向患者和医疗从业者销售我们产品的批准，他们越来越认识到维生素D充足水平在我们日常健康中的重要性。”

NanoSpeed noted that point-of-care testing (POCT), which allows medical testing near the individual and outside of clinical laboratories, offers an alternative.

NanoSpeed指出，即时检验（POCT）能够在个体附近且临床实验室之外进行医疗检测，提供了一种替代方案。

POCT can potentially reduce errors and healthcare expenses while providing rapid clinical diagnoses.

POCT有可能减少错误和医疗费用，同时提供快速的临床诊断。

In response to the growing need for vitamin D testing, the company created this POCT device for the identification of 25-OH vitamin D via fingertip puncture in human blood.

为应对日益增长的维生素D检测需求，该公司开发了这款POCT设备，用于通过指尖穿刺检测人体血液中的25-OH维生素D。

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