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簡(jiǎn)要描述(shù):新(xīn)生(shēng)兒檢(jiǎn)測(cè)用紙 Neonatal Screeningwhatman樣(yàng)本(běn)收集紙(zhǐ)903號濾紙(zhǐ)903濾紙903紙 Whatman 提(tí)供(gōng)一係列用(yòng)於(yú)新(xīn)生兒檢(jiǎn)測的產品(pǐn)。這些(xiē)產(chǎn)品還可應用於醫(yī)學(xué)檢驗,家(jiā)用血(xiě)標本采集(jí)試劑(jì)盒及標本檔(dàng)案建立等(děng)用途。利(lì)用(yòng)樣本(běn)收集試紙(zhǐ),研(yán)究者(zhě)可以(yǐ)從多種來(lái)源獲得用於分(fēn)析(xī)的樣本(běn),不僅(jǐn)可從特(tè)定(dìng)實驗(yàn)室環(huán)境中獲(huò)得,還可在更(gēng)復雜(zá)的(dí)條(tiáo)件(jiàn)下(xià)獲(huò)得(dé)。對樣(yàng)本收(shōu)集(jí)來說,樣(yàng)本的均(jūn)一(yī),穩定及特性的(dí)保持是非常(cháng)重要的,
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whatman樣(yàng)本(běn)收(shōu)集紙903號濾紙(zhǐ)903濾紙903紙(zhǐ)
新生兒檢(jiǎn)測用紙 Neonatal Screeningwhatman樣(yàng)本收集紙903號濾(lǜ)紙(zhǐ)903濾(lǜ)紙903紙
Whatman
提供一(yī)係列用於(yú)新生兒檢(jiǎn)測(cè)的產品(pǐn)。這些產品還可(kě)應用(yòng)於醫學檢驗,家用血標本(běn)采集試(shì)劑(jì)盒(hé)及標(biāo)本檔案(àn)建立等用(yòng)途。利用樣(yàng)本收(shōu)集(jí)試(shì)紙,研究者可以(yǐ)從多種來源獲得(dé)用(yòng)於(yú)分析(xī)的樣本(běn),不僅可從特定實(shí)驗室(shì)環境中(zhōng)獲(huò)得,還可在更復雜的(dí)條件(jiàn)下(xià)獲得(dé)。對樣(yàng)本收(shōu)集來說,樣本的(dí)均(jūn)一,穩定(dìng)及(jí)特性的保持是非常重(zhòng)要的(dí),
Whatman 為您(nín)提供(gōng)的產(chǎn)品可滿足您這(zhè)方麵的(dí)要(yào)求。
903 樣本收集紙 903 Specimen Collection paper
人體液體(tǐ)標本的(dí)收集(jí)和轉移(yí) For Body Fluid Sample Collection and Transport
自 Dr. Robert *了新生兒苯酮酸尿(niào)症的(dí)檢(jiǎn)測方(fāng)法後(hòu), 903 紙(zhǐ)便(biàn)成為人體液(yè)體標(biāo)本的收集,轉(zhuǎn)移,分析(xī)和(hé)建立(lì)檔案(àn)用(yòng)試紙(zhǐ)的(dí)標(biāo)準。903
紙(zhǐ)作為一款通(tōng)過美(měi)國 FDA
驗(yàn)證(zhèng)通過的(dí)體(tǐ)外(wài)二級(jí)診斷(duàn)用產品,在(zài)美國(guó)國(guó)內有著(zhuó)廣(guǎng)泛的應(yīng)用,在(zài)世界(jiè)範圍內(nèi)也應用(yòng)於(yú)相(xiāng)當多的(dí)新(xīn)生(shēng)兒檢測項(xiàng)目中。對(duì)於(yú)苯(běn)酮酸尿症(zhèng)來(lái)說,越早檢測(cè)出來,治(zhì)愈的(dí)可(kě)能性越大。除(chú)此之外(wài),
903 紙還(huán)可(kě)應用於半乳(rǔ)糖症,支(zhī)鏈酮尿(niào)症,鏈(liàn)狀(zhuàng)細(xì)胞貧(pín)血症等其(qí)他疾(jí)病。
穩定性保證(zhèng) Guaranteed Consistency
在生(shēng)產試紙(zhǐ)的過程中 Whatman 擁(yōng)有標準(zhǔn)的(dí)操作程序(xù)。控製精(jīng)良(liáng)的(dí)設備(bèi)確(què)保產品質量的均一性(xìng)及(jí)各項參數(shù)的可控性。考慮到(dào)試紙的組分(fēn)對產(chǎn)品穩(wěn)定性的(dí)影(yǐng)響,
Whatman 嚴格(gé)地(dì)控製生產過(guò)程(chéng)來(lái)保證(zhèng)產(chǎn)品組分(fēn),厚度,吸(xī)收(shōu)速(sù)率(shuài)及均(jūn)一(yī)性(xìng)的穩(wěn)定。
生產過程(chéng)保證(zhèng) Manufacture Quality Assurance
903 紙由(yóu) 100% 純(chún)棉絨(róng)製成,無(wú)任何濕(shī)強填加(jiā)劑。 Whatman 保證(zhèng)每個批號(hào)的(dí)產品在正常的使用條件下可(kě)維(wéi)持(chí) 12 個月(yuè)。 903
紙*符合美國(guó) FDA 質(zhì)量(liáng)體(tǐ)係的(dí)相(xiāng)關(guān)規定(dìng)。 CLSI 關(guān)於新生(shēng)兒檢測(cè)樣本選擇有三(sān)個(gè)關鍵(jiàn)指(zhǐ)標: 903
紙對一定(dìng)量的血液樣(yàng)本(běn)的(dí)血液(yè)吸(xī)收,血(xiě)清提取及血液在(zài)試紙上(shàng)斑點的大(dà)小。在(zài)這方麵(miàn) Whatman 也滿(mǎn)足(zú)其(qí)要求。 Whatman QA 在生(shēng)產(chǎn)過(guò)程(chéng)中監測
903
紙的(dí)一定量(liáng)血液樣(yàng)本的血(xiě)液吸收(shōu),斑點大(dà)小(xiǎo)這兩(liǎng)個指(zhǐ)標(biāo)。另外(wài),每一批的樣品檢(jiǎn)測包括血(xiě)清提(tí)取(qǔ)指標都(dū)由(yóu)獨(dú)立的(dí)實驗(yàn)室和新(xīn)生兒疾(jí)病控製(zhì)中(zhōng)心檢測(cè)。當(dāng)且(qiě)僅當(dāng)所有(yǒu)指標(biāo)都符合(hé)
CLSI 的規範,產品方(fāng)可投入市場(cháng)。
後印刷保(bǎo)證(zhèng) Post-Printing Quality Assurance
在(zài)很(hěn)多應用中,會(huì)把 903 紙(zhǐ)印成(chéng)表格形(xíng)式,便(biàn)於記(jì)錄(lù)被檢(jiǎn)測(cè)病(bìng)人的(dí)一些信(xìn)息。新生(shēng)兒篩選用的樣本(běn)收集(jí)卡(qiǎ)片的印刷(shuā)過程(chéng)是(shì)根(gēn)據(jù) NCSL
標準嚴格控(kòng)製。不(bù)正(zhèng)確(què)的印刷(shuā)會(huì)砑光(guāng)或(huò)壓(yā)碎(suì)紙,影(yǐng)響(xiǎng)吸附性能。因(yīn)此 Whatman 就血液(yè)吸收(shōu)時間,斑點大(dà)小(xiǎo)等指(zhǐ)標(biāo)對印(yìn)刷的(dí)產品(pǐn)做隨機抽查(chá)。 Whatman
可提(tí)供這部(bù)分的分析(xī)報(bào)告(gào)。
903 的其(qí)他(tā)用(yòng)途 Beyond Neonatal Testing
除(chú)了用(yòng)於新生(shēng)兒 DBS 檢測, 903 紙(zhǐ)還被廣泛(fàn)地(dì)應用(yòng)於(yú)各種樣本的(dí)收(shōu)集(jí),包(bāo)括 HIV , HCV ,血(xiě)紅(hóng)蛋白(bái)等血樣(yàng)本的(dí)收集。另(lìng)外, 903
紙還將(jiāng)樣本(běn)中的其他信息(xī)一(yī)並攜(xié)帶至(zhì)醫學實驗室用(yòng)於其他(tā)測試,例如,血(xiě)鉛(qiān)水平(píng)測試。在(zài)流(liú)行(háng)病(bìng)學研究中 903 紙是(shì)一種理想的收集(jí)樣(yàng)本的(dí)介(jiè)質。
幹(gān)燥支(zhī)架(jià) Dry Rak for Collection Drying
幹燥(zào)支(zhī)架設計出來(lái)是便於同(tóng)時(shí)幹燥多個樣(yàng)品。將附(fù)有樣(yàng)本(běn)的 903
紙放(fàng)置於(yú)支架插槽中(zhōng),懸空豎立安(ān)全地(dì)進行空(kōng)氣(qì)幹(gān)燥(zào)血液樣本(běn)。支架的(dí)設計形狀也使得其(qí)易於安(ān)放。
多功能新(xīn)生(shēng)兒卡片 903 Multiple-part Neonatal Card
試(shì)紙下方可(kě)記錄新(xīn)生(shēng)兒,父母(mǔ),醫生,護(hù)士的(dí)信(xìn)息。每(měi)張試紙上都有(yǒu)一個(gè)*的(dí)序列號(hào)和(hé)條(tiáo)形(xíng)碼。收(shōu)集(jí)樣品(pǐn)區域是試紙的上方 5 個直徑半英(yīng)寸(cùn)的(dí)環,每(měi)個環可吸收
75-80ul 的(dí)血液(yè)樣(yàng)本。
903 蛋(dàn)白保護卡 903 Protein Saver Card
903 蛋白保(bǎo)護(hù)卡(qiǎ)上的收集區域(yù)是(shì) 5 個半(bàn)英寸(cùn)直徑的圓圈(quān)。每個圓圈可(kě)吸收(shōu) 75-80ul
的血(xiě)液樣本。使用時封麵可折疊以(yǐ)保(bǎo)護樣(yàng)本,上(shàng)有(yǒu)標(biāo)識指(zhǐ)出(chū)樣本可能的生物(wù)危(wēi)險(xiǎn)性。該產品獲(huò)得 CE 認證,並配(pèi)有鋁箔袋(dài)用於(yú)保(bǎo)存。
訂貨信息(xī)—— 903 樣(yàng)本收集(jí)紙(zhǐ)係列
貨(huò)號產品(pǐn)名稱(chēng)包(bāo)裝價(jià)格 ( 元 )
1 210 × 297mm100 片 / 盒(hé)1413
1 460 × 570mm100 片(piàn) / 盒4689
1 580 × 580mm100 片 / 盒4861
1 蛋(dàn)白保(bǎo)護卡(qiǎ)100 片(piàn) / 盒(hé)1369
1 多功(gōng)能(néng)紙(zhǐ)100 片 / 盒1408
1 幹燥(zào)支架(含尼龍搭扣)10 片(piàn) / 盒352
10548232塑(sù)料儲(chǔ)存(cún)袋 4 × 6 英寸(cùn)100 片(piàn) / 盒177
10548236薄(báo)玻璃紙信(xìn)封 3 (1 / 4) × 4 (7 / 8) 英(yīng)寸(cùn)100 片(piàn) / 盒(hé)196
10548234幹燥(zào)劑100 片(piàn) / 盒151
10495010手(shǒu)動取樣(yàng)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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