whatman樣本收集紙903號(hào)濾紙903濾紙903紙

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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