新生兒檢測用紙 Neonatal Screeningwhatman樣本收集紙903號濾紙903濾紙903紙 Whatman
提供一系列用于新生兒檢測的產(chǎn)品。這些產(chǎn)品還可應(yīng)用于醫(yī)學(xué)檢驗(yàn)、家用血標(biāo)本采集試劑盒及標(biāo)本檔案建立等用途。利用樣本收集試紙，研究者可以從多種來源獲得用于分析的樣本，不僅可從特定實(shí)驗(yàn)室環(huán)境中獲得，還可在更復(fù)雜的條件下獲得。對樣本收集來說，樣本的均一、穩(wěn)定及特性的保持是非常重要的，

whatman樣本收集紙903號濾紙903濾紙903紙

       
        
      新生兒檢測用紙 Neonatal Screeningwhatman樣本收集紙903號濾紙903濾紙903紙
      Whatman 
      提供一系列用于新生兒檢測的產(chǎn)品。這些產(chǎn)品還可應(yīng)用于醫(yī)學(xué)檢驗(yàn)、家用血標(biāo)本采集試劑盒及標(biāo)本檔案建立等用途。利用樣本收集試紙，研究者可以從多種來源獲得用于分析的樣本，不僅可從特定實(shí)驗(yàn)室環(huán)境中獲得，還可在更復(fù)雜的條件下獲得。對樣本收集來說，樣本的均一、穩(wěn)定及特性的保持是非常重要的， 
      Whatman 為您提供的產(chǎn)品可滿足您這方面的要求。
       
      903 樣本收集紙 903 Specimen Collection paper
      人體液體標(biāo)本的收集和轉(zhuǎn)移 For Body Fluid Sample Collection and Transport
      自 Dr. Robert *了新生兒苯酮酸尿癥的檢測方法后， 903 紙便成為人體液體標(biāo)本的收集、轉(zhuǎn)移、分析和建立檔案用試紙的標(biāo)準(zhǔn)。903 
      紙作為一款通過美國 FDA 
      驗(yàn)證通過的體外二級診斷用產(chǎn)品，在美國國內(nèi)有著廣泛的應(yīng)用，在世界范圍內(nèi)也應(yīng)用于相當(dāng)多的新生兒檢測項(xiàng)目中。對于苯酮酸尿癥來說，越早檢測出來，治愈的可能性越大。除此之外， 
      903 紙還可應(yīng)用于半乳糖癥，支鏈酮尿癥，鏈狀細(xì)胞貧血癥等其他疾病。
      穩(wěn)定性保證 Guaranteed Consistency 
      在生產(chǎn)試紙的過程中 Whatman 擁有標(biāo)準(zhǔn)的操作程序。控制精良的設(shè)備確保產(chǎn)品質(zhì)量的均一性及各項(xiàng)參數(shù)的可控性。考慮到試紙的組分對產(chǎn)品穩(wěn)定性的影響， 
      Whatman 嚴(yán)格地控制生產(chǎn)過程來保證產(chǎn)品組分、厚度、吸收速率及均一性的穩(wěn)定。
      生產(chǎn)過程保證 Manufacture Quality Assurance
      903 紙由 100% 純棉絨制成，無任何濕強(qiáng)填加劑。 Whatman 保證每個批號的產(chǎn)品在正常的使用條件下可維持 12 個月。 903 
      紙*符合美國 FDA 質(zhì)量體系的相關(guān)規(guī)定。 CLSI 關(guān)于新生兒檢測樣本選擇有三個關(guān)鍵指標(biāo)： 903 
      紙對一定量的血液樣本的血液吸收，血清提取及血液在試紙上斑點(diǎn)的大小。在這方面 Whatman 也滿足其要求。 Whatman QA 在生產(chǎn)過程中監(jiān)測 
      903 
      紙的一定量血液樣本的血液吸收，斑點(diǎn)大小這兩個指標(biāo)。另外，每一批的樣品檢測包括血清提取指標(biāo)都由獨(dú)立的實(shí)驗(yàn)室和新生兒疾病控制中心檢測。當(dāng)且僅當(dāng)所有指標(biāo)都符合 
      CLSI 的規(guī)范，產(chǎn)品方可投入市場。
      后印刷保證 Post-Printing Quality Assurance 
      在很多應(yīng)用中，會把 903 紙印成表格形式，便于記錄被檢測病人的一些信息。新生兒篩選用的樣本收集卡片的印刷過程是根據(jù) NCSL 
      標(biāo)準(zhǔn)嚴(yán)格控制。不正確的印刷會砑光或壓碎紙，影響吸附性能。因此 Whatman 就血液吸收時間、斑點(diǎn)大小等指標(biāo)對印刷的產(chǎn)品做隨機(jī)抽查。 Whatman 
      可提供這部分的分析報(bào)告。
      903 的其他用途 Beyond Neonatal Testing 
      除了用于新生兒 DBS 檢測， 903 紙還被廣泛地應(yīng)用于各種樣本的收集，包括 HIV ， HCV ，血紅蛋白等血樣本的收集。另外， 903 
      紙還將樣本中的其他信息一并攜帶至醫(yī)學(xué)實(shí)驗(yàn)室用于其他測試，例如，血鉛水平測試。在流行病學(xué)研究中 903 紙是一種理想的收集樣本的介質(zhì)。
       
      干燥支架 Dry Rak for Collection Drying
      干燥支架設(shè)計(jì)出來是便于同時干燥多個樣品。將附有樣本的 903 
      紙放置于支架插槽中，懸空豎立安全地進(jìn)行空氣干燥血液樣本。支架的設(shè)計(jì)形狀也使得其易于安放。 
      多功能新生兒卡片 903 Multiple-part Neonatal Card
      試紙下方可記錄新生兒，父母、醫(yī)生、護(hù)士的信息。每張?jiān)嚰埳隙加幸粋€*的序列號和條形碼。收集樣品區(qū)域是試紙的上方 5 個直徑半英寸的環(huán)，每個環(huán)可吸收 
      75-80ul 的血液樣本。
      903 蛋白保護(hù)卡 903 Protein Saver Card
      903 蛋白保護(hù)卡上的收集區(qū)域是 5 個半英寸直徑的圓圈。每個圓圈可吸收 75-80ul 
      的血液樣本。使用時封面可折疊以保護(hù)樣本，上有標(biāo)識指出樣本可能的生物危險性。該產(chǎn)品獲得 CE 認(rèn)證，并配有鋁箔袋用于保存。
       
      訂貨信息—— 903 樣本收集紙系列
            貨號產(chǎn)品名稱包裝價格 ( 元 )
            10535097903 210 × 297mm100 片 / 盒1413
            10538017903 460 × 570mm100 片 / 盒4689
            10538018903 580 × 580mm100 片 / 盒4861
            10534612903 蛋白保護(hù)卡100 片 / 盒1369
            10537279903 多功能紙100 片 / 盒1408
            10539521903 干燥支架（含尼龍搭扣）10 片 / 盒352
            10548232塑料儲存袋 4 × 6 英寸100 片 / 盒177
            10548236薄玻璃紙信封 3 (1 / 4) × 4 (7 / 8) 英寸100 片 / 盒196
            10548234干燥劑100 片 / 盒151
            10495010手動取樣器 3.1mm個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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