CGL-A 2017 Kit Instructions CAP 2017

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Kit Contents

CGL CGL-01 — CGL-05 (one vial each, lyophilized plasma) CG-DDA (one vial, lyophilized plasma)

CGD-S1 (one vial, liquid serum) Dry lab challenge

CGDF CGD-S1 (one vial, liquid serum) CG-DDA (one vial, lyophilized plasma)

CGB CGL-01 — CGL-05 (one vial each, lyophilized plasma) Dry lab challenge

Important: The Kit Contents lists all possible orderable programs for this mailing. Your laboratory will only receive the programs it ordered.

Important: Before You Begin

New for this Mailing

1. Beginning with this mailing, the result form is available in an HTML format via e-LAB Solutions Suite. Depending on the program’s reporting requirements, sections of the result form may include logic that flags missing required information (eg, units of measure, methods). Your laboratory must still verify and approve all data prior to the due date.

2. CGL and CGB participants: An ungraded, optional dry educational challenge has been added to the result form.

3. The reporting areas for Fibrinogen Activity have been modified. Enter your results and method information in the result form area that corresponds to the unit of measure used in your laboratory.

Reporting Code Changes

The following manufacturers have either deleted or updated codes for this mailing: None

Storage and Stability Instructions

1. Keep specimens refrigerated at 2 - 8ºC until testing can be performed. 2. Once open, perform testing immediately.

CGL-A

2017

Kit Instructions

Coagulation, Limited Survey

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Critical Reporting Information

1. For any testing that you do not routinely perform in your laboratory, leave all reporting areas for that test blank unless otherwise noted.

2. Laboratories using direct INR will not receive the calculated INR Special Report, as the mean normal prothrombin time and ISI values are not reported by this group.

3. Fibrinogen assay applies to clot based-Clauss or PT method. Laboratories performing fibrinogen antigen testing should consider enrolling in the Coagulation, Extended (CGE) Survey.

4. Please use the correct International Sensitivity Index (ISI) for your INR calculations. The ISI varies not only with the lot of reagent, but also with the instrument being used. If you have any questions, contact the reagent manufacturer.

Detailed Testing Instructions

Reconstitution Instructions

1. To reconstitute lyophilized specimens, add exactly 1.0 mL of distilled or deionized water to each vial using a class A volumetric pipette or pipette for which accuracy has been defined and deemed acceptable for the intended use.

2. Restopper and swirl gently to mix.

3. Allow to stand 15 minutes at room temperature for complete rehydration. 4. Following the 15 minutes of rehydration, gently swirl the vial.

5. Perform all assays within 2 hours of complete hydration.

6. If your laboratory wishes to obtain additional material for testing, you may do so by ordering the Coagulation, Limited Validated Material (CGM) from the Customer Contact Center.

Reporting Your Results

General Reporting Instructions

1. All laboratories subject to Clinical Laboratory Improvement Amendments (CLIA) regulations: If your laboratory is beginning or discontinuing testing on any CMS-regulated analyte, you must check your CMS Analyte Reporting Selections to ensure no changes are needed. You can maintain your laboratory’s current reporting preferences by accessing the application via e-LAB Solutions Suite under Proficiency Testing/Quality Management.

2. Each mailing, verify the accuracy of your reporting codes (eg, manufacturer, method, instrument, reagent) by reviewing the online result form or the Method Summary Page attached to the front of your result form.

3. The inclusion of reporting codes on the result form does not imply US FDA approval. 4. Exception Codes: If you must report an analytical problem for a test or individual

analyte, leave the result area for that section blank and select one of the following bubbles on the result form within that section. The exception code bubble that you select will apply only to the result area(s) left blank. Documentation on the use of these codes is the responsibility of the laboratory and should be kept internally.

• 11 Unable to analyze

Use code 11 to indicate why specimens were not analyzed (eg, instrument not functioning, reagents not available).

• 22 Result is outside the method/instrument reportable range

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your method or instrument. Do not use this code if there is an option to select greater than or less than.

• 33 Specimen unsatisfactory

To use code 33, you must contact the CAP.

If you select an exception code bubble and enter data on the result form, the data will be graded.

5. Certain sections of the result form include options for less than or greater than values. Select an option if appropriate and enter your lowest or highest detectable limit in the boxes provided or refer to the use of exception codes.

6. Quantitative results for this Survey can now be automatically transmitted using e-LAB Solutions Connect. To learn more, visit cap.org and search for e-LAB Solutions Connect.

Prothrombin Time (PT) - Graded

1. An interpretation (prolonged or not prolonged) section is included on the result form for each specimen. Select one response according to the criteria used in your laboratory. This portion of the Survey is not graded.

2. Provide the ISI value of your thromboplastin in the boxes provided.

3. Provide the mean value of the reference range used to calculate your INR value. Siemens BCS users that report the PT and INR:

• Mean Normal Prothrombin Time value: Report the “US Setting” of the Mean Normal Prothrombin Time that is located in your instrument.

• International Sensitivity Index (ISI): Contact your manufacturer to determine the “US Setting” of your ISI value.

International Normalized Ratio (INR) - Graded

1. In addition to the current grading scheme that is based upon the comparison of your laboratory’s INR to that of your peer group, a second evaluation will be provided. This evaluation will compare your laboratory’s reported INR to a calculated INR that is based upon your reported ISI, your Mean Normal Prothrombin Time used to calculate the INR, and the Prothrombin Time (PT) result reported for each challenge. The calculated INR evaluation will be sent separately from your CGL evaluation. 2. The additional grading scheme will require that if you report the PT and INR, the ISI

and Mean Normal Prothrombin Time (PT) must be reported. Activated Partial Thromboplastin Time (aPTT) - Graded

1. An interpretation (prolonged or not prolonged) section is included on the result form for each specimen.

2. Select one response according to the criteria used in your laboratory. This portion of the Survey is not graded.

Fibrin(ogen) Degredation Product (FDP) Serum - Ungraded

1. For purposes of proficiency testing, perform FDP Serum testing without any dilutions. 2. Based on the value obtained, interpret and report as normal or increased.

FDP Plasma - Ungraded

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D-dimer - Quantitative - Graded

1. If you report a quantitative result, provide your instrument/reagent code from the D-dimer Master List (Quantitative Only). Report your quantitative value in the boxes provided. Select the option that corresponds to your reporting units and your interpretation on the result form. Failure to provide your reagent or reporting units will result in unacceptable performance for this challenge.

2. In order to be evaluated appropriately, you must report the correct unit of measure. Refer to your manufacturer’s package insert or contact your manufacturer to determine the appropriate type of units that you report with the test that you are using.

Note: D-dimer can be measured and reported in either Fibrinogen Equivalent Units (FEU) or D-dimer Units (DDU). Among current manufacturers of kits to measure D-dimer, the type of units used is evenly distributed between FEU and DDU. 3. Once you have confirmed the type of the units that you are measuring, analyze the

D-dimer challenge in this mailing and report to the CAP the value in exactly the same way that a specimen would be reported on one of your patients. Include the correct units that you use clinically (ie, ng/mL; µg/L) and the type of units (FEU or DDU). Accuracy of this information is critical for the correct grading of the challenge. 4. Siemens/Sysmex D-dimer users: At the request of the manufacturer, reporting

codes for D-dimer (Quantitative) have changed. Review the chart below and enter the appropriate code on your result form.

If your instrument system is: Report the following code:

Siemens B-series

Siemens/Sysmex CA-series 3243 Siemens Advanced D-Dimer(Select one.)

1885 Siemens D-Dimer PLUS (outside US) 3412 Siemens Innovance

Siemens/Sysmex CS-series (outside US) 3412 Siemens Innovance Siemens Stratus CS 3228 Siemens Stratus CS

D-dimer Interpretation - Ungraded

For the interpretation of D-dimer values, compare your test result with a reference range based on a normal population. A reference range based on a normal population is typically defined as the central 95% of results determined on a population of healthy people (ie, without disease). Each laboratory usually establishes its own reference range for the population being served. If your laboratory does not report a reference range based on a normal population when reporting D-dimer results on actual clinical samples, select No reference range established on the result form.

D-dimer - Semi-Quantitative/Qualitative - Ungraded

If you report a semi-quantitative/qualitative result, provide your reagent code from the D-dimer Master List (Semi-Quantitative/Qualitative Only) and select your interpretation on the result form.

Submitting Results

1. Results must be received at the CAP no later than midnight, Central Time by the due date on the result form.

2. Your site administrator must establish a Web account via cap.org and opt in your laboratory. Information about opting in and a unique PIN was emailed to all laboratory directors. If your laboratory director does not have this information, contact the CAP. 3. Laboratory staff who enter results online must first create a personal Web account,

affiliate themself with a laboratory, then log in.

Per CLIA, as published by the United States Federal Register

• Proficiency Testing (PT) specimens must be tested with the laboratory’s regular workload, using routine methods, and testing the PT specimens the same number of times it routinely tests patient specimens.

• If referral for testing is routinely performed for patient specimens, the practice cannot be followed for PT specimens. Referral is considered to be movement of the specimen from a laboratory with a CLIA identification number to another laboratory that has a different CLIA identification number. • Laboratories must ensure that

personnel do not share results or refer PT specimens for any reflex or testing outside their CLIA identification number.

Disclaimer

Survey specimens, their progeny, unmodified derivatives, or modifications thereof may not be transferred or incorporated into a program intended for sale. Survey specimens, their progeny, unmodified derivatives, or modifications thereof, reagents, and disposable equipment used in PT, when disposed of, should be autoclaved or incinerated and disposed of as hazardous waste. Disposal must follow local regulations, if more stringent than regulations enforced by the CDC or the FDA.

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Biohazard Warning

All Survey specimens should be treated as if potentially infectious and should be handled as if they are capable of transmitting disease.

Survey specimens are prepared from blood or other source material obtained from human donors or animals.

When working with Survey specimens, precautions should be taken to protect yourself and others from accidental exposure to infectious agents such as HIV, HBV, and HCV. HIV can be transmitted through accidental parenteral inoculation, mucous membranes, or non-intact skin contact with HIV infected blood or body fluids. HBV and HCV can be transmitted through accidental parenteral inoculation, mucous membranes, non-intact skin contact, aerosolization or ingestion.

Precautions described in CDC and FDA recommendations and OSHA blood borne pathogen rules should be followed at all times when handling Survey specimens and reagents.

Such precautions include the following:

• Gloves should be put on before opening the container and should be kept on throughout the period specimens are handled. Replace gloves if contaminated, or if their ability to function as a barrier is compromised.

• At high altitudes, specimens should be opened in a hood or biologic safety cabinet. • There should be no eating, drinking, or smoking in the laboratory.

• Hands should be washed after removing gloves and before leaving the testing area. • Survey specimens and reagents should be kept in separate refrigerators from those

containing blood or blood components for transfusion.

• Survey specimens, reagents, and disposable equipment used in testing should be autoclaved or incinerated and disposed of as hazardous waste. Disposal must follow local regulations, if more stringent than regulations enforced by the CDC or the FDA. If there has been an accident in which you have been exposed to the Survey’s materials, please call the CAP Hot Line at 800-443-3244 (domestic) or

001-847-470-2812 (international) at any time. You can access Safety Data Sheets (SDS/MSDS) by logging on to cap.org, clicking on the Laboratory Improvement tab, then Catalog and Ordering Information.

For Assistance

For replacement materials, please contact the CAP within 10 calendar days of the ship date for information. Provide your CAP number and contact information with all correspondence. Participants in countries serviced by a designated CAP distributor should contact their distributor’s customer service department.

Telephone: 800-323-4040 option 1

(Monday - Friday, 7:00 am – 5:30 pm US Central Time)

International Participants: 001-847-832-7000 option 1 Email: [email protected]

Website: cap.org

Address: CAP Surveys Program 325 Waukegan Road Northfield, IL 60093-2750

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aPTT, Prothrombin Time, INR, and Direct INR Instrument Master List

Manual 1324 Loop 1325 Tilt Tube Fibrin Strand Detection 1334 Adams-Thrombitron 1335 BBL (Bio-Quest) Fibrometer 1337 Emdeco Prothrombin Timer 1338 Helena Dataclot 2

1339 Mechrolab Clot Timer 202A 1163 Medtronic HemoTec ACT 1153 Medtronic HemoTec Act II 1340 Other, specify on result form

Mechanical

1103 Diagnostica Stago ST4, STart 4, STart 8

1011 Diagnostica Stago STA 1010 Diagnostica Stago STA Compact 1796 Diagnostica Stago STA Compact Max 1815 Diagnostica Stago STA Satellite 1929 Diagnostica Stago STA-R, STA-R

Evolution, STA-R Max 1019 Tcoag AMAX 190/200/400 2000 Tcoag Destiny series 1009 Tcoag KC series

Photo-Optical

1376 Astral Medical Systems Coatron 1377 Astral Medical Systems Coatron Junior 1378 Astral Medical Systems Coatron II 2165 Behnk/Tcoag Thrombolyzer (all models),

Coag-A-Mate MAX

1353 Bio-Data Coagulation Profiler 1373 Bio-Data MCA 110, 210, 310 1354 Bio-Dynamics Coagulation Unimeter 500 1355 Bio-Dynamics Coagulation Unimeter 600 1369 Elvi 818 1375 Elvi 820 2007 EMDS Easy ST 1105 Fisher ThromboScreen 1000 1025 Grifols Q Hemostasis Analyzer 1107 Helena Cascade 480 1137 Helena Cascade M 1022 Helena Cascade POC 2107 Helena Thor

1360 Hyland Clotek 1361 Hyland Fibrintimer II 1980 IL ACL 1000, 7000 1593 IL ACL Elite, Elite Pro 1036 IL ACL Futura/Advance

1679 IL ACL TOP series

1382 Labor American CD1000, CD2000, CD3000, COA Systems

1383 Labor American COA Screener 1362 Lancer Coagulyzer, All Models 1195 Roche Cobas FIBRO

1033 Sekisui Coapresta (CP) 2000/3000 1583 Siemens BCS, BCS XP 1060 Siemens BCT 1988 Siemens BFT II 1167 Siemens/Sysmex CA-series 3374 Siemens/Sysmex CS-series

2155 Sysmex CA-series (Japan users only) 3365 Sysmex CS-series (Japan users only) 1006 Tcoag AMAX 190/200/400 (optical) 2104 Tcoag Coag-A-Mate MTX 1359 Tcoag Coag-A-Mate X-2

2075 Tcoag Coag-A-Mate XC series, RA4 1133 Tcoag Coag-A-Mate XM

2071 Tcoag Destiny series (optical) 1218 Tcoag MDA series

1371 Other, specify on result form

Deleted codes

None

Inclusion on this master list does not imply US FDA approval.

New/Updated codes

None

Human Placental Thromboplastin

1848 Helena Cascade POC Test Card 1064 Siemens Thromborel S 0010 Other, specify on result form

Pure-Brain Thromboplastin

2144 ACS Thrombex 3087 Bio-Data Plastinex

2249 Bio-Dynamics Thromboplastin 1309 Diagnostica Stago Neoplastine CI 1310 Diagnostica Stago Neoplastine CI Plus 2056 George King Bio-Medical

2815 Helena Thromboplastin, ISI 2.0-2.5 1900 Helena Thromboplastin LI, ISI<1.2

Recombinant Human Tissue Factor Thromboplastin

1187 Diagnostica Stago STA Neoplastine R 1802 HemosIL ReadiPlasTin

2553 HemosIL RecombiPlasTin 2G 1868 R2 Diagnostics Phosphoplastin R 2145 Siemens Innovin

1774 Tcoag TriniCLOT PT HTF 0010 Other, specify on result form

Recombinant Rabbit Tissue Factor Thromboplastin

1083 Grifols DG 1568 ThermoDMA 3353 Tulip Diagnostics

Prothrombin Time, INR, and Direct INR Reagent Master List

1146 Helena Thromboplastin MI, ISI 1.55-1.85 1159 HemosIL PT-FIB

1144 HemosIL PT-FIB HS Plus 1863 Sekisui

1551 Tcoag TriniCLOT PT Excel 2139 Tcoag TriniCLOT PT Excel S 2588 Thermo/Pacific Hemostasis Thromboplastin-D 2112 Thermo/Pacific Hemostasis Thromboplastin-DL 1355 Thermo/Pacific Hemostasis Thromboplastin-DS 0010 Other, specify on result form

Deleted codes

None New/Updated codesNone

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1848 Helena Cascade POC Test Card 1145 HemosIL APTT-SP

3240 HemosIL SynthAFax 1801 HemosIL SynthASil 1962 Precision Biologicals

1867 R2 Diagnostics Phospholin RSA 1863 Sekisui

2179 Siemens Actin 2181 Siemens Actin FS 1520 Siemens Actin FSL 1859 Siemens Pathromtin SL

aPTT Reagent Master List

2146 ACS Spectra APTT 3089 Bio-Data Cephalinex

1186 Diagnostica Stago STA Cephascreen 2205 Diagnostica Stago STA C.K. Prest 1910 Diagnostica Stago STA-PTT A 2056 George King Bio-Medical 1083 Grifols DG

1141 Grifols DG-CaCl2 2816 Helena APTT Reagent 1901 Helena APTT-ES 2147 Helena APTT-SA

2314 Tcoag Automated APTT Reagent 1066 Tcoag TriniCLOT aPTT HS 1483 Tcoag TriniCLOT aPTT HS

(with TriniVeriCAL) 1065 Tcoag TriniCLOT aPTT S 1484 Tcoag TriniCLOT aPTT S

(with TriniVeriCAL) 1568 ThermoDMA

2113 Thermo/Pacific Hemostasis APTT-XL 2561 Thermo/Pacific Hemostasis Kontact 2160 Other, specify on result form

Deleted codes

Fibrinogen Instrument Master List

Deleted codes

Mechanical Fibrin Polymer Detection

1103 Diagnostica Stago ST4, STart 4, STart 8

1011 Diagnostica Stago STA 1010 Diagnostica Stago STA Compact 1796 Diagnostica Stago STA Compact Max 1815 Diagnostica Stago STA Satellite 1929 Diagnostica Stago STA-R, STA-R

Evolution, STA-R Max 1885 Fibrometer

1019 Tcoag AMAX 190/200/400 2000 Tcoag Destiny series (mechanical) 1009 Tcoag KC series

2122 Other Mechanical, specify on result form

Optical Detection

2165 Behnk/Tcoag Thrombolyzer (all models), Coag-A-Mate MAX

1353 Bio-Data Coagulation Profiler

1373 Bio-Data MCA 110, 210, 310 1105 Fisher ThromboScreen 1000 1025 Grifols Q Hemostasis Analyzer 1107 Helena Cascade 480 1137 Helena Cascade M 2107 Helena Thor 1980 IL ACL 1000, 7000 1593 IL ACL Elite, Elite Pro 1036 IL ACL Futura/Advance 1679 IL ACL TOP series

1382 Labor American CD1000, CD2000, CD3000, COA Systems

1383 Labor American COA Screener 2023 Roche COBAS FARA 1816 Roche COBAS MIRA

1033 Sekisui Coapresta (CP) 2000/3000 1583 Siemens BCS, BCS XP 1060 Siemens BCT 1988 Siemens BFT II 1167 Siemens/Sysmex CA-series 3374 Siemens/Sysmex CS-series

3365 Sysmex CS-series (Japan users only) 1006 Tcoag AMAX 190/200/400

2104 Tcoag Coag-A-Mate MTX 1359 Tcoag Coag-A-Mate X-2

2075 Tcoag Coag-A-Mate XC series, RA4 1133 Tcoag Coag-A-Mate XM

2071 Tcoag Destiny series 1218 Tcoag MDA series

1371 Other Optical, specify on result form

Prothrombin Time Based Optical Detection

1018 Bio-Data MCA 110, 210

1069 Other Prothrombin Time, specify on result form

Other

1884 Manual (Tilt Tube)

1242 Becton Dickinson QBC AUTOREAD 1243 Becton Dickinson QBC Reference Inclusion on this master list does not imply US FDA approval.

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Deleted codes

Ammonium Sulfate Precipitation (Parfentjev-Fowell Method)

2587 Other Ammonium Sulfate, specify on result form

Clauss Method (Modified Thrombin Time)

1525 Diagnostica Stago 1083 Grifols DG

2111 Helena Fibrinogen Assay 1395 HemosIL Fibrinogen-C 3155 HemosIL QFA 1863 Sekisui

2180 Siemens Fibrinogen Determination (Dade Thrombin)

1126 Siemens Multifibren U 3160 Tcoag (Biopool) Fibrinogen Kit 2313 Tcoag FibriQuik

1361 Tcoag MDA FibriQuik

2053 Tcoag TriniCLOT Fibrinogen (AMAX) 3039 Thermo/Pacific Hemostasis Fibrinogen

Assay

2527 Other Clauss, specify on result form

Ellis-Stransky Method (Thrombin Turbidimetric Rate)

3187 Kamiya K-Assay

2525 Other Ellis-Stransky, specify on result form

Heat Precipitation

1108 Becton Dickinson QBC Fibrinogen 1155 Other Heat Precipitation, specify on

result form

Fibrinogen Reagent Master List

Immunologic Fibrinogen Assay

1384 Binding Site RID

2348 DiaSorin Immunoturbidimetric 1018 Other Immunologic, specify on result

form

Prothrombin Time Based Fibrinogen Assay

1159 HemosIL PT-FIB 1144 HemosIL PT-FIB HS Plus 1802 HemosIL ReadiPlasTin 2553 HemosIL RecombiPlasTin 2G 2145 Siemens Innovin

1064 Siemens Thromborel S

1259 Other PT Based Fibrinogen, specify on result form

Other Method

2160 Other, specify on result form Inclusion on this master list does not imply US FDA approval.

FDP (Plasma Only) Reagent Master List

FDP (Plasma Only) Method Master List

1540 Latex slide test using anti-FDP 1637 Turbidimetric/Immunoturbidimetric 1098 Other, specify on result form

1525 Diagnostica Stago 2095 Murex Diagnostics 1863 Sekisui

1351 Sysmex

Deleted codes

None New/Updated codesNone Deleted codesNone New/Updated codesNone

FDP (Serum Only) Reagent Master List

FDP (Serum Only) Method Master List

1540 Latex slide test using anti-FDP 1546 Slide test for Staphylococcal clumping

1547 Tanned red cell hemogglutination inhibition immunoassay (TRCHII) 1637 Turbidimetric/Immunoturbidimetric

2399 Ortho 1863 Sekisui 2451 Siemens 1170 Tcoag

3090 Thermo/Pacific Hemostasis Thromboscreen 1610 Thrombo Welco

2160 Other reagent, specify on result form

Deleted codes

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D-dimer Master List

3229 Alere (Biosite) Triage 1606 American Diagnostica 2086 BioLis/Prestige 24i

1056 BioMerieux VIDAS/miniVIDAS 1314 Diagnostica Stago Asserachrom 1422 Diagnostica Stago Liatest 1083 Grifols DG

2256 HemosIL D-Dimer - IL ACL 7000, 8000, 9000,10000, Elite, Elite Pro 2257 HemosIL D-Dimer - IL ACL Futura/Advance, TOP

2258 HemosIL D-Dimer HS IL ACL TOP series 3420 HemosIL D-Dimer HS 500 - IL ACL TOP series 3526 HemosIL D-Dimer HS 2000 - IL ACL TOP series 3187 Kamiya K-Assay

1173 Roche Cardiac Reader 1134 Roche cobas c series 1807 Roche COBAS Integra

3381 Roche COBAS Integra - Heparin setpoint 3382 Roche Hitachi/cobas c - Heparin setpoint 3236 Roche Modular

1863 Sekisui

3243 Siemens Advanced D-Dimer 1885 Siemens D-Dimer PLUS (outside US) 3412 Siemens Innovance

3228 Siemens Stratus CS 2488 Tcoag Auto D-Dimer (AMAX) 2608 Tcoag (Biopool) AutoDimer 2904 Tcoag MDA AutoDimer

2531 Thermo/Pacific Hemostasis Di-STAT System 2160 Other, specify on result form

1606 American Diagnostica 1525 Diagnostica Stago 1236 Grifols DG-Fibrinlis 1788 HemosIL Dimertest 1609 Mabco (Agen) 2095 Murex Diagnostics 2259 Siemens Dimertest 1811 Tcoag Accuclot 2880 Tcoag (Biopool) Minutex 1149 Thermo/Pacific Hemostasis 2160 Other, specify on result form

Instrument/Reagent Master List

Reagent Master List

Quantitative Only

Semi-quantitative/Qualitative Only

Deleted codes

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CGL-A 2017 Kit Instructions CAP 2017

Kit Contents

Important: Before You Begin

CGL-A

2017

Kit Instructions

Table of Contents

Coagulation, Limited Survey

Detailed Testing Instructions

Reporting Your Results

Biohazard Warning

For Assistance

aPTT, Prothrombin Time, INR, and Direct INR Instrument Master List

Prothrombin Time, INR, and Direct INR Reagent Master List

aPTT Reagent Master List

Fibrinogen Instrument Master List

Fibrinogen Reagent Master List

FDP (Plasma Only) Reagent Master List

FDP (Plasma Only) Method Master List

FDP (Serum Only) Reagent Master List

FDP (Serum Only) Method Master List

D-dimer Master List

Instrument/Reagent Master List

Reagent Master List

Quantitative Only

Semi-quantitative/Qualitative Only