D.16 Ancillary Testing.docx

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Q201--Copy of Meridian CBOC
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36C25623R0002
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This document contains product specifications for medical diagnostic tests and related equipment required by the Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 16. Tests specified include Medline hCG Pregnancy Test combo cassettes with a sensitivity of 20 mIU/mL for urine and 10 mIU/mL for serum, Abbott Clearview hCG Controls for quality assurance, Cardinal Health Strep A Rapid Tests with a sensitivity of 97% and specificity of 95%, and Abbott ID Now COVID-19 Molecular tests providing results in 5 minutes. Equipment specified is the Rapid Influenza A & B FIA Sofia Influenza A&B analyzer. The solicitation number is 36C25623R0002 for the Q201 Meridian CBOC opportunity to supply these medical diagnostic products and services.

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Ancillary Testing

Medline hCG Pregnancy Test, Combo+ Test Cassette, 20/10 mIU/mL Item # MED MPH22025HCG by Medline (Mfg. Part # MPH22025HCG,) Fast, accurate results for early detection; results in 3 minutes using urine and 5 minutes using serum; sensitivity: >99% Urine strips and cassettes have a sensitivity of 25 mIU/mL; combo urine/serum cassettes have a sensitivity of 20 mIU/mL for urine and 10 mIU/mL for serum CLIA waived using urine; Moderately Complex using serum Recommended controls: Abbott Clearview hCG Controls (item #ALR92218) Cutoff: 20 - Urine Quantity Pack: 25 Sample Type: Urine Sensitivity: 99% Test Format: Cassette

Cardinal Health™ Strep A Rapid Tests are CLIA-waived rapid chromatographic iCat. B1077-30 Cardinal Health™ Strep A Dipstick Test 50/test immunoassays for the qualitative detection of Strep A antigen from throat swab

• Positive results in 5 minutes

• Room temperature storage

• Sensitivity 97%; specificity 95%

ABBOTT ID Now COVID -19 Molecular Instrument Based Molecular POCT results in 5minutes -

Rapid Influenza A & B FIA Sofia Influenza A&B is the method used in Micro

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