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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 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.
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| > Multipart Neonatal
Card |
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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 |
| Description |
Quantity/Pack |
Catalogue Number |
| 903 Protein Saver Card |
100 |
10 534 612 |
| 903 Multiple-part Neonatal Card |
100 |
10 537 279 |
| 903 Protein Saver™ Card (EU) |
100 |
10 531 018 |
| 903 Protein Saver Snap-apart Card |
100 |
10 534 320 |
| 903 - 210 x 297mm |
100 |
10 535 097 |
| 903 - 460 x 570mm |
100 |
10 538 017 |
| 903 - 580 x 580mm |
100 |
10 538 018 |
| Desiccant packs |
100 |
10 548 234 |
| Foil-barrier ziplock bags |
100 |
10 534 321 |
| Plastic Ziploc® storage bags 4 inches x
6 inches |
100 |
10 548 232 |
| Glassine envelopes 3 1/4 inches x 4 7/8
inches |
100 |
10 548 236 |
| Biohazard labels 7/8 inches x 7/8 inches |
1000 |
10 534 150 |
| Dry Rak (with velcro) |
10 |
10 539 521 |
| Dry Rak (without velcro) |
10 |
10 537 173 |
| Hand punch, 3.1 mm |
1 |
10 495 010 |
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+32 (0) 16
58 90 45 
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