新生兒檢測(cè)用紙 Neonatal Screeningwhatman樣本收集紙903號(hào)濾紙903濾紙903紙 Whatman 提供一系列用于新生兒檢測(cè)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(lái)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(duì)樣本收集來(lái)說(shuō)，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 開創(chuàng)了新生兒苯酮酸尿癥的檢測(cè)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國(guó)際標(biāo)準(zhǔn)。903 紙作為一款通過美國(guó) FDA 驗(yàn)證通過的體外二級(jí)診斷用產(chǎn)品，在美國(guó)國(guó)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(cè)項(xiàng)目中。對(duì)于苯酮酸尿癥來(lái)說(shuō)，越早檢測(cè)出來(lái)，**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**。 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?？刂凭嫉脑O(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?？紤]到試紙的組分對(duì)產(chǎn)品穩(wěn)定性的影響， Whatman 嚴(yán)格地控制生產(chǎn)過程來(lái)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(wú)任何濕強(qiáng)填加劑。 Whatman 保證每個(gè)批號(hào)的產(chǎn)品在正常的使用條件下可維持 12 個(gè)月。 903 紙完全符合美國(guó) FDA 質(zhì)量體系的相關(guān)規(guī)定。 CLSI 關(guān)于新生兒檢測(cè)樣本選擇有三個(gè)關(guān)鍵指標(biāo)： 903 紙對(duì)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(cè) 903 紙的一定量血液樣本的血液吸收，斑點(diǎn)大小這兩個(gè)指標(biāo)。另外，每一批的樣品檢測(cè)包括血清提取指標(biāo)都由獨(dú)立的實(shí)驗(yàn)室和新生兒**控制中心檢測(cè)。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(chǎng)。 后印刷保證 Post-Printing Quality Assurance 在很多應(yīng)用中，會(huì)把 903 紙印成表格形式，便于記錄被檢測(cè)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(huì)砑光或壓碎紙，影響吸附性能。因此 Whatman 就血液吸收時(shí)間、斑點(diǎn)大小等指標(biāo)對(duì)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(cè)， 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(cè)試，例如，血鉛水平測(cè)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(lái)是便于同時(shí)干燥多個(gè)樣品。將附有樣本的 903 紙放置于支架插槽中，懸空豎立**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€(gè)**的序列號(hào)和條形碼。收集樣品區(qū)域是試紙的上方 5 個(gè)直徑半英寸的環(huán)，每個(gè)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(gè)半英寸直徑的圓圈。每個(gè)圓圈可吸收 75-80ul 的血液樣本。使用時(shí)封面可折疊以保護(hù)樣本，上有標(biāo)識(shí)指出樣本可能的生物危險(xiǎn)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(hào) 產(chǎn)品名稱 包裝 價(jià)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 蛋白保護(hù)卡 100 片 / 盒 1369 10537279 903 多功能紙 100 片 / 盒 1408 10539521 903 干燥支架（含尼龍搭扣） 10 片 / 盒 352 10548232 塑料儲(chǔ)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(dòng)取樣器 3.1mm 個(gè) 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.

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