简要描述：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，
详细介绍
whatman样本收集纸903号滤纸903滤纸903纸
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 *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*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 )
10535097903 210 × 297mm100 片 / 盒1413
10538017903 460 × 570mm100 片 / 盒4689
10538018903 580 × 580mm100 片 / 盒4861
10534612903 蛋白保护卡100 片 / 盒1369
10537279903 多功能纸100 片 / 盒1408
10539521903 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.
Ordering Information – 903? Specimen Collection Paper
DescriptionQuantity/PackCatalogue Number
903 Protein Saver Card10010 534 612
903 Multiple-part Neonatal Card10010 537 279
903 Protein Saver? Card (EU)10010 531 018
903 Protein Saver Snap-apart Card10010 534 320
903 – 210 x 297mm10010 535 097
903 – 460 x 570mm10010 538 017
903 – 580 x 580mm10010 538 018
Desiccant packs10010 548 234
Foil-barrier ziplock bags10010 534 321
Plastic Ziploc? storage bags 4 inches x 6 inches10010 548 232
Glassine envelopes 3 1/4 inches x 4 7/8 inches10010 548 236
Biohazard labels 7/8 inches x 7/8 inches100010 534 150
Dry Rak (with velcro)1010 539 521
Dry Rak (without velcro)1010 537 173
Hand punch, 3.1 mm110 495 010
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