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Newborn Blood Spot Collection Kits


Location
Oklahoma
Publication Date
02/20/2020 01:14 PM EST
Closing Date
03/02/2020 04:00 PM EST
Issuing Organization
State of Oklahoma-Department of Health
Solicitation Number
Description

Specifications include, but are not limited to: Filter paper Matrix Specifications – before printing 1. Filter paper shall be a recent lot of S&S 903 or equivalent 100% pure cotton fiber, filter paper with no wet-strength additives or equivalent. Lot number to be printed on the filter paper attachment of page 3. 2. Basis weight should be 110 lb. +/- 5% per read (550 sheets 24 x 35 inches). 3. Densitometer reading by Gurley method on one sheet with a 5 oz. Cylinder, 0.1 sq. orifice and 100 cc of air (Test method, modified ASTM D7266-58). 4. pH should be 5.7 to 7.5 5. Ash% 0.2 maximum (Test method, modified ASTM D726-63) 6. Kelmn: Tappi modified useful method – UM451 7. Wet strength (ASTM D-774-67), usually around 4/5 lbs./inch sq. 8. Absorption rate: The absorption time and the diameter of blood spot produced by 100 uL. Of a fresh whole blood sample (hematocrit 55 +/- 1%). Absortion time target: 12 seconds; range 5-30 seconds. Diameter target: 16mm; range 15-17 mm volume. Ragged edges or mottling or dried blood spot should not be observed. 1/8 inch punch of the dried blood spot should equate to a blood volume of 1.54 +/- 0.17 uL. 9. Lithographic printing is not an acceptable printing process for the filter paper. A dedicated ink delivery system used only for filter paper printing is recommended. Ink specifications: 1. Printing ink must not interfere in analytical test procedures. Data must be available, if requested to validate the compatibility of the ink for the following tests: Phenylalanine, Amino Acid disorders, Galactose, Galactose 1- phosphate Uridyl Transferase, Thyroxine, Thyroid Stimulating Hormone, Cystic Fibrosis, Congenital Hyperplasia, Medium Chain Acyl CoA Dehydrogenase, Fatty Acid oxidation disorders, Organic Acid disorders, SCID and others. 2. Circles on the filter paper must be a thin black broken line and must be same dimensions as shown on the attached sample (0.5 inches or 13 mm in diameter) 3. Page 1. Print using green ink with white headings and green check boxes and all other printing in black ink. See example. 4. Page 2. Print on yellow paper with green ink with white headings and green check boxes and all other printing in black ink. Use red ink for wording on CHART COPY. See example. 5. Print serial numbers on filter paper in black ink. 6. Page 5 Collecting specimens. Use red ink for expiration date on filter paper. Drawings outlined in black ink with foot having green ink showing the area for collection in green and red no designation for where not to draw sample. Use red ink in correct /acceptable circle as well as wrong/unacceptable circles as shown on example. Use red tear drop in circle marked with one drop, one circle, one time. 7. Page 6 front and back print use red ink to print first lines of text. See example. All other printing in black ink. Packing specifications: 1. Forms shall be packaged in protective loose wrap in bundles of approximately 100 in numerical order. NOTE: Shrink wrap or use of heat in packaging is not acceptable and will affect the absorption capacity of the filter paper. 2. Bundles shall be boxed in number order with bundles (forms) flat and not shipped on their side. 3. Boxes shall be number on the exterior with the serial number sequence.

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