新生儿检测用纸 Neonatal Screeningwhatman样本收集纸903号滤纸903滤纸903纸 Whatman 提供一系列用于新生儿检测的产品。这些产品还可应用于医学检验、家用血标本采集试剂盒及标本档案建立等用途。利用样本收集试纸，研究者可以从多种来源获得用于分析的样本，不仅可从特定实验室环境中获得，还可在更复杂的条件下获得。对样本收集来说，样本的均一、稳定及特性的保持是非常重要的， Whatman 为您提供的产品可满足您这方面的要求。   903 样本收集纸 903 Specimen Collection paper 人体液体标本的收集和转移 For Body Fluid Sample Collection and Transport 自 Dr. Robert 首创了新生儿苯酮酸尿症的检测方法后， 903 纸便成为人体液体标本的收集、转移、分析和建立档案用试纸的国际标准。903 纸作为一款通过美国 FDA 验证通过的体外二级诊断用产品，在美国国内有着广泛的应用，在世界范围内也应用于相当多的新生儿检测项目中。对于苯酮酸尿症来说，越早检测出来，治愈的可能性越大。除此之外， 903 纸还可应用于半乳糖症，支链酮尿症，链状细胞贫血症等其他疾病。 稳定性保证 Guaranteed Consistency 在生产试纸的过程中 Whatman 拥有标准的操作程序。控制精良的设备确保产品质量的均一性及各项参数的可控性。考虑到试纸的组分对产品稳定性的影响， Whatman 严格地控制生产过程来保证产品组分、厚度、吸收速率及均一性的稳定。 生产过程保证 Manufacture Quality Assurance 903 纸由 100% 纯棉绒制成，无任何湿强填加剂。 Whatman 保证每个批号的产品在正常的使用条件下可维持 12 个月。 903 纸完全符合美国 FDA 质量体系的相关规定。 CLSI 关于新生儿检测样本选择有三个关键指标： 903 纸对一定量的血液样本的血液吸收，血清提取及血液在试纸上斑点的大小。在这方面 Whatman 也满足其要求。 Whatman QA 在生产过程中监测 903 纸的一定量血液样本的血液吸收，斑点大小这两个指标。另外，每一批的样品检测包括血清提取指标都由独立的实验室和新生儿疾病控制中心检测。当且仅当所有指标都符合 CLSI 的规范，产品方可投入市场。 后印刷保证 Post-Printing Quality Assurance 在很多应用中，会把 903 纸印成表格形式，便于记录被检测病人的一些信息。新生儿筛选用的样本收集卡片的印刷过程是根据 NCSL 标准严格控制。不正确的印刷会砑光或压碎纸，影响吸附性能。因此 Whatman 就血液吸收时间、斑点大小等指标对印刷的产品做随机抽查。 Whatman 可提供这部分的分析报告。 903 的其他用途 Beyond Neonatal Testing 除了用于新生儿 DBS 检测， 903 纸还被广泛地应用于各种样本的收集，包括 HIV ， HCV ，血红蛋白等血样本的收集。另外， 903 纸还将样本中的其他信息一并携带至医学实验室用于其他测试，例如，血铅水平测试。在流行病学研究中 903 纸是一种理想的收集样本的介质。
	干燥支架 Dry Rak for Collection Drying 干燥支架设计出来是便于同时干燥多个样品。将附有样本的 903 纸放置于支架插槽中，悬空竖立安全地进行空气干燥血液样本。支架的设计形状也使得其易于安放。
	多功能新生儿卡片 903 Multiple-part Neonatal Card 试纸下方可记录新生儿，父母、医生、护士的信息。每张试纸上都有一个唯壹的序列号和条形码。收集样品区域是试纸的上方 5 个直径半英寸的环，每个环可吸收 75-80ul 的血液样本。
	903 蛋白保护卡 903 Protein Saver Card 903 蛋白保护卡上的收集区域是 5 个半英寸直径的圆圈。每个圆圈可吸收 75-80ul 的血液样本。使用时封面可折叠以保护样本，上有标识指出样本可能的生物危险性。该产品获得 CE 认证，并配有铝箔袋用于保存。
订货信息—— 903 样本收集纸系列 货号 产品名称 包装 价格 ( 元 ) 10535097 903 210 × 297mm 100 片 / 盒 1413 10538017 903 460 × 570mm 100 片 / 盒 4689 10538018 903 580 × 580mm 100 片 / 盒 4861 10534612 903 蛋白保护卡 100 片 / 盒 1369 10537279 903 多功能纸 100 片 / 盒 1408 10539521 903 干燥支架（含尼龙搭扣） 10 片 / 盒 352 10548232 塑料储存袋 4 × 6 英寸 100 片 / 盒 177 10548236 薄玻璃纸信封 3 (1 / 4) × 4 (7 / 8) 英寸 100 片 / 盒 196 10548234 干燥剂 100 片 / 盒 151 10495010 手动取样器 3.1mm 个 118

For Body Fluid Sample Collection & Transport
Since Dr. Robert Guthrie first published procedures for screening newborns for Phenylketonuria (PKU), the 903 specimen collection paper has been the international standard for body fluid sample collection, transport, analysis and archiving.

The 903 paper, an FDA-registered in vitro Class II medical device, is used in virtually all U.S. newborn screening programs and in most newborn screening programs throughout the world. Widespread testing for phenylketonuria (PKU) has lead to early detection and intervention for tens of thousands of babies in the U.S. Newborn screening programs today screen for, depending on the state, anywhere from three to eleven or more analytes, including congenital hypothyroidism, galactosemia, branched-chain ketonuria, maple sugar urine disorder and sickle-cell anemia. More recently, with the advent of tandem mass spectrometry technology, many programs are adding less frequently occurring disorders to their panel of analytes, including MCAD, cystic fibrosis and a range of amino acid disorders.

Guaranteed consistency

Whatman maintains statistical process control (SPC) over the manufacture of 903 specimen collection paper. State-of-the-art equipment ensures uniformity and adherence to specified parameter ranges. Since the stability of the collected sample can be affected by the composition of the paper, Whatman carefully controls the manufacturing process to ensure consistent omposition, uniform thickness, flow-rate, absorbency and purity.

Manufacturing quality assurance

The 903 paper is manufactured from 100% pure cotton linters with no wet- strength additives. Whatman guarantees to the newborn screening community that each lot of paper that is manufactured will last for at least 12 months at current usage levels.

Since it is a medical device, 903 paper is manufactured and tested according to FDA Quality System Regulations and must meet a performance standard. The critical parameters, as defined in the CLSI consensus standard for newborn screening sample collection, are blood absorbency, serum uptake and circle size for a specified volume of blood.

Whatman Quality Assurance tests 903 paper for blood absorbency and circle size throughout the manufacturing run. In addition, the same tests, plus serum uptake, are also conducted for each lot of 903 paper by an independent testing lab and by the Centers for Disease Control Newborn Screening Quality Assurance Program. Only when all test results confirm that of lot of 903 paper meets the CLSI specifications is that lot released for use for specimen collection.

Post-printing quality assurance

For most applications, the 903 paper is printed and provided as part of a form that includes detailed demographic information about the patient being tested. The process for the printing of specimen collection paper to be used for neonatal screening is strictly defined in the NCCLS standard. Improper printing can calender or crush the paper, negatively impacting its absorption characteristics. This can result in unacceptably long absorption times, “layering” of blood spots and incomplete absorption. Because of this, Whatman Quality Assurance tests a random sampling of forms from all printed collection form lots for blood absorption time, circle size, and caliper. A certificate of analysis is available upon request for each lot of printed blood collection forms.

Beyond neonatal testing

While initially used for newborn screening from dried blood spots (DBS), 903 paper is now also widely used for the collection of many types of samples, including collection of blood samples for HIV, HCV and hemoglobin A1c testing. In addition, there are a number of tests that incorporate 903 paper for physician office collection of samples that are then sent to a central laboratory for analysis, e.g., blood lead-level monitoring. The 903 paper is ideal medium on which to collect samples for epidemiological studies.

> Dry Rak

Dry Rak for collection card drying

The Whatman Dry Rak is designed to accommodate multiple collection forms at one time, safely and properly air-drying the blood specimens in a suspended horizontal position (CLSI Document LA4-A3, vol. 17 No. 16). The Dry Rak is easily assembled, and can be affixed to a wall or counter top with optional velcro stickers.

Whatman offers a variety of generic collection cards that meet the requirements for many sampling programs.

> Multipart Neonatal Card

Multiple-part Neonatal Card

The multipart neonatal card includes a demographic portion in duplicate where information about the newborn, parents, physician and care can be entered. Each card has a unique sequential number and bar code. The tipped-on 903 collection paper is imprinted with five 1/2″ circles and has a wrap-around cover to protect the 903 paper before and after sample collection. Each circle holds 75- 80 µL of blood.

903 Protein Saver™ card

The sample collection area of the 903 Protein Saver Card contains five one-half-inch circles. Each circle holds 75-80 µL of sample. Wraparound cover has spaces for name and date of collection, and is imprinted with the universal biohazard symbol in conformance with USPS regulations. It carries the CE mark for the European Union and fits into Whatman foil barrier ziplock bags for storage.

Protein Saver snap-apart card

The 903 paper in this device, imprinted with four one-half-inch circles, is enclosed between two pieces of cover stock. Each circle holds 75-80 µl of sample. To use, one cover is snapped off, the sample is collected and the remaining cover is folded over the sample. This cover is imprinted with the universal biohazard symbol in conformance with USPS regulations.

Regulation Disclaimer – CE mark

Under regulations that went into effect in December 2003, specimen collection cards, including neonatal screening cards, which are to be used for human diagnostic tests, are classified as “other” IVD devices under the European IVD Directive and require the CE mark if sold within the European Union. All 903 specimen collection devices manufactured and printed by Whatman for human diagnostic testing in the EU undergo post-printing quality control and carry the CE mark. Whatman will assume no responsibility for the quality or performance of 903 collection devices converted, printed or packaged by third party suppliers.

Training materials

Educational materials illustrating the proper method for collecting neonatal samples are available from Whatman in six languages: English, German, French, Italian, Spanish and Brazilian Portuguese. Please contact our technical specialists.