Newborn Screening

  • – TFN collection cards make the blood sample handling process simpler and more cost-effective
  • Manufactured from 100% high purity cotton linters
  • Consistency and reliability of the absorbent media guarantee the highest blood specimen quality
  • Compliant with CLSI LA4-LA5 standard
  • CE marked in EU as ‘sample vessel’ within the meaning of the Directive 98/79/EC, IVD Device
  • TFN cards can be customized to your specifications, shapes and sizes

The Specimen Collection Paper for Blood Sampling and Newborn Screening.

Munktell Ahlstrom TFN filter paper collection cards allow the collection of blood specimens, and transportation and long-term storage of dried blood samples.

Blood specimens are simply absorbed on the card surface and let dry in air. They can be later shipped at room temperature to the analytical laboratory. A small surface containing the specimen is then punched and removed from the card, and screening tests can be performed through simple protocols.

In newborn screening blood is usually collected from the baby’s heel during the first 48 to 72 hours after birth. The number of diseases and genetic disorders screened for varies in different countries and is depending from new born screening programs throughout the world. New born screening programs screen today from two to up to 50+ analytes.

The success of screening tests performed on dried blood specimens depends to a great extent on the quality
of the specimen, and ultimately on the consistency
and reliability of the storage media. At Munktell Ahlstrom we have got the longest experience in paper making and the latest technology to offer unrivalled quality
and reliability in products and components for diagnostics and Life Science applications.

Applications
TFN cards are used by healthcare professionals for new born screening programs,
e.g. testing for congenital hypothyroidism, phenylketonuria (PKU) and many other genetic disorders.
Blood samples are collected, transported, analyzed and archived on TFN cards as a support. TFN cards are also suitable for collection of blood specimens for other applications, and of other bio-samples for diagnostic applications.

Characteristics
TFN filter paper cards are manufactured from 100% pure cotton linters without wet-strength additives.
The stability of the collected specimen is influenced by the paper properties: the entire manufacturing process is closely controlled to ensure consistent composition, uniform thickness, flow rate, purity and absorbency, guaranteeing the highest quality.
The CLSI (Clinical and Laboratory Standards Institute) defines the critical parameters for blood absorbency,
serum uptake and circle size for a specified volume of blood. TFN has been tested by an independent testing lab, according to that newborn screening quality assurance program. TFN filter paper complies with this standard.

Physical Property Unit Requirements Typical Values
Basis Weight g/m2 179 g/m2 ± 5% (110 lb ± 5%) 179
pH-value 5.7 to 7.5 7.0

CE Mark
Grade TFN paper is classified as ‘sample vessel’ within the meaning of the Directive 98/79/EC, IVD Device.
It requires the CE mark if sold within the European Union. All TFN specimen collection devices manufactured and printed by Munktell for neonatal testing in the EU carry the CE mark.
Munktell will take over only responsibility for the quality or performance of TFN collection devices converted, printed or packaged by us.

Quality Management System
Munktell’s quality management system is certified to conform to the requirements of ISO 13485.

Customized Solutions
TFN cards can be supplied in standard formats or customized to your specifications, shapes and sizes. You can call us today for technical support and samples.