Attachment_1_-_Salient_Characteristics.pdf

SALIENT CHARACTERISTICS / ESSENTIAL CONDITIONS

(Reagents, Coagulation)

Operation Conditions:

All items listed below shall be compliant with the Diagnostica Stago – STA Compact Max Coagulation Analyzer currently owned by the 48 MDG Lab. Reagents and consumables supplied as “Or Equal” must fulfill product descriptions listed below, and be within manufacturer parameters to ensure no harm or breach of warranty to the analyzer.

The contractor shall provide an initial setup of the reagents, perform initial validation calibration, linearity, instrumental validation, within run precision, between run precision, normal range studies and patient comparison. The product/report must be in accordance with CAP/JC guidelines. The presentation/data will be bound in notebook and/or digital form and presented to the lab’s accrediting bodies within two weeks from installation. The contractor shall guarantee that reagents provided shall be sequestered lots to reduce lot-to-lot validation, calibration and quality control testing. Sequestered lots allow for specific lots to be set aside for a laboratory for up to one (1) year.

Essential Characteristics:

Reagents

CLIN Product Brand Name Product description Quantity

0001 STA-Neoplastine CI Plus 5 Determination of Prothrombin Time (PT) by STA® analyzers

(ISI~1.3).

Freeze-dried rabbit brain thromboplastin with heparin inhibitor.

6 x 5 mL vials of

STA®

Neoplastine® CI Plus 5

6 x 5 mL vials of Solvent

0002 STA – Cephascreen 4 Determination of the activated partial thromboplastine time (APTT) in plasma by analyzers of the STA line suitable with this reagent.

0003 STA Liatest D-Dimer Plus Quantitative determination of D-dimer in venous plasma (in 3.2% sodium citrate) for use on STA analyzers. It is used to exclude pulmonary embolism (PE) and as an aid in the diagnosis of deep venous thrombosis.

0004 STA-Coag Control N + ABN

Plus Normal and abnormal control plasmas for PT INR, APTT, fibrinogen, thrombin time, and thrombin time, and antithrombin.

12 x 2 mL vials of STA® - Coag Control N Plus

12 x 2 mL vials of STA® - Coag Control ABN Plus

0005 STA DDi Control Includes two assayed reagents intended for the quality control od D-dimer tests by quantitative immuno-turbidimetric method.

0006 STA-CaCl2 0.025M Aqueous solution of calcium chloride intended for the clotting tests such as the activated partial thromboplastine time (APTT) or the assays of intrinsic pathway factors.

24 x 15 mL

0007 STA-Owren-Koller Buffer Buffer solution intended for use as a diluent for reagents and patient samples in coagulation studies.

24 x 15 mL

Consumables

0012 STA Micro Reducer Supply specific to STA instrument parameters designed as integral part of the analyzer system.

0013 Stir-Bars Supply specific to STA instrument parameters designed

0014 O-rings Supply specific to STA

0015 Teflon Tips Supply specific to STA

0016 STA-Microtainers (for samples)

Supply specific to STA instrument parameters designed as integral part of the analyzer system.

500 each

0008 STA-Mini Reducer (5 mL vials)

Supply specific to STA instrument parameters designed as integral part of the analyzer system.

100 each

0009 STA-Cleaner Solution Supply specific to STA instrument parameters designed as integral part of the analyzer system.

6 x 2.5 L

0010 STA-Desorb U Decontaminating solution for use with STA analyzer designed as integral part of the analyzer system.

24 x 15 mL

0011 STA-Cuvettes Supply specific to STA instrument parameters designed as integral part of the analyzer system.

6 x 1000 (STA Compact® & STA- R®)

38640 Frigoporteur Methanol and ethylene glycol solution designed as integral part of the analyzer system.