whatman样本收集纸903号滤纸903滤纸903纸新生儿采血纸 903 specimen collection paper 上海摩速科学器材有限公司-凯发官方首页

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.

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.