Chemistry Programs

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Chemistry


ADULTERATED URINE TEST

Two simulated urine specimens per testing event, 10 mL

The specimens are for use with adulterant detection methods testing creatinine, pH, nitrate, oxidants and specific gravity.  Perform testing according to lab protocol.  Report specimen interpretation of adulterated or normal according to protocol.


ALCOHOL

Five liquid specimens per testing event, 2.0 mL

The specimens are for the analysis of Acetone, Beta hydroxybutyrate, and Ethanol. They contain 1.0 g/L of sodium azide as preservative. Code reagent from the list on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event.


AMMONIA, PLASMA


Two liquid specimens per testing event, 2.0 mL

The specimens are for the analysis of ammonia.

Code reagent from the list on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event.


BILIRUBIN, SUPPLEMENTAL, 2-VIAL

Two liquid specimens per testing event, 1.0 mL, for the following analytes:


Direct Bilirubin        

Neonatal Bilirubin

Total Bilirubin


BILIRUBIN, SUPPLEMENTAL, 5-VIAL

Five liquid specimens per testing event, 1.0 mL, for the following analytes:


Direct Bilirubin        

Neonatal Bilirubin

Total Bilirubin

Specimens are ready to use:

1.        Do not open the vial until immediately before you are ready to test.  Invert gently 5-10 seconds prior to sampling

2.        Dispense the amount needed for testing and immediately re-stopper the vial and return it to the refrigerator. Keep vials tightly capped and protected from direct light until testing is completed.

3.        Minimize the samples exposure to air.


The specimens should be processed as fresh patient serum. Code reagents from the lists on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event.

BLOOD GASES

Five aqueous specimens per testing event, 1.7 mL

For the following analytes:


Chloride

pCO2

Potassium

Glucose

pH

Sodium

Ionized Calcium

pO2



Duplicate specimens are sent in each shipment. Participants must process these specimens in the following manner:

  1. Before using, the specimens must be brought to room temperature (20-28ºC). If the material has been stored at temperatures above or below this range, remove ampules from the box and allow 1 hour for the material to equilibrate to room temperature. The gas-liquid equilibrium in each sealed ampule is dependent upon temperature. The most precise measurements will be obtained when storage temperature is controlled at 25ºC. The parameter most sensitive to temperature is pO2; it changes inversely with temperature approximately one percent per degree.
  2. To complete the equilibration of gas and liquid phases, shake the ampules vigorously for at least fifteen seconds immediately prior to use. Hold the ampules at the tip and the bottom (with forefinger and thumb) to minimize temperature changes in the specimens.
  3. Protect fingers with gauze, tissue or gloves and carefully snap off the neck of the ampule.
  4. Introduce sample from the ampule within one minute after opening, using the procedure below which is appropriate to the transfer method required:
    1. Direct Aspiration: each specimen may be sampled directly from the ampule.
    2. Syringe Transfer: after opening an ampule, immediately insert a 20 gauge, 1 inch needle fitted to a clean, gas-tight syringe. Aspirate the specimen slowly from the bottom of the ampule without entrapping any air bubbles. Expel one or two drops through the needle, detach the needle from the syringe and immediately inject the sample directly into the instrument port.


Please test samples as patients unless specifically directed otherwise by AAB or your instrument manufacturer’s directions.

Roche/AVL Omni users please note:  Per manufacturer’s instructions you must run the samples in “patient mode” and not in “aqueous mode”.

Chloride, Glucose, Potassium and Sodium-Do not report results from vials labeled Basic Chemistry here.

Code your method/instrument using the list on the reporting form instructions.


CARDIAC MARKERS, 2-VIAL

Two liquid samples per testing event, 1.5 mL, for the following analytes:


BNP

NT-proBNP

Myoglobin

Troponin I

Troponin T


Test samples immediately upon receipt. If testing cannot be performed within 24 hours of receipt, store samples refrigerated at 2° to 8° C. Allow samples to sit at RT (20-28° C) for 15-20 minutes before testing.  See analyte specific instructions below in 5-vial section.


Code reagents from the lists on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event.


CARDIAC MARKERS, 5-vial

Five liquid samples per testing event, 1.5 mL, for the following analytes:


BNP

CK2 (CK-MB), U/L, or ng/mL

Troponin I


NT-proBNP

Myoglobin

Troponin T



  1. Test samples immediately upon receipt. If testing cannot be performed within 24 hours of receipt, store samples    refrigerated at 2° to 8° C.
  2. Allow to sit at room temperature (20-28° C) for 15-20 minutes before testing.
  3. Code reagents from the lists on the reporting form and code the instrument from the list found in the General Instructions or the Addendum, which is included with each testing event.



CK2 (CK-MB)-The reagent codes reported for CK2 (CK-MB) Isoenzymes reflect the units U/L, or ng/mL in which results are reported. However, participants must report their results directly, without conversion to other units. For example, participants using activity-based or mass-based methods must report their results only in U/L or ng/mL, respectively.


Troponin-Please test as soon as possible after receipt of specimens.


CAP participants must enroll in the Cardiac Markers 5 vial program for BNP, proBNP, Troponin I and Troponin T


CHEMISTRY, BASIC

Five liquid serum specimens per testing event, 5.0 mL, for the following analytes:


Alanine Aminotransferase (ALT or SGPT)

Bilirubin, Total

Glucose

Total Protein

Aspartate Aminotransferase (AST or SGOT)

Calcium

Phosphorus

Triglyceride

Albumin

Chloride

Potassium

Urea Nitrogen

Alkaline Phosphatase

Cholesterol, Total

Pregnancy (hCG), Serum

Uric Acid

Bicarbonate

Creatinine

Sodium



Code the method and instrument from the list found in the General Instructions or the Addendum, which is included with each testing event.


Calcium-Results must be rounded to one decimal place and reported in mg/dL. To convert to mg/dL, multiply mmol/L by 4 and mEq/L by 2. If reporting ionized calcium concentrations, code your reagent as 0061 (all ionized calcium methods) for proper grading.


Creatinine-Vitros DT-60 participants using the 2-slide (ammonia-based) method should not report results based on diluted specimens if the diluted result is less than 7.5 mg/dL.


These samples are not compatible with the Nova CRT enzymatic method.


Electrolytes-Diluted or indirect ISE methods are those in which the sample is introduced to the electrode along with the diluent. In undiluted or direct ISE methods, the sample is passed directly to the electrode without being diluted. Undiluted methods tend to give higher readings, especially for sodium and chloride. Because of this, correction factors may be employed to make undiluted methods agree with diluted ISE and flame photometer methods. Use reagent codes labeled “diluted ISE” or “dil ISE” if you use a diluted method. Use reagent codes labeled “und ISE” for ISE methods with no diluent and use reagent codes labeled “und ISE/flame eq.” for undiluted ISE methods with a flame photometer correction factor.


Glucose-Do not report glucose values on the Basic Chemistry form using visual strip tests or instruments (usually hand-held) that generate whole blood glucose values. Whole blood glucose values are not equivalent to serum glucose values. Many whole blood instruments, such as the Abbott Vision and the Roche Reflotron do give serum glucose results and should be reported on the Basic Chemistry form. True whole blood glucose results can only be reported on specimens in the Whole Blood Glucose program.


Pregnancy (hCG), Serum-Basic and Comprehensive Chemistry vials can only be used to report serum pregnancy results. Results obtained using Basic and Comprehensive Chemistry vials must be reported on the Basic or Comprehensive Chemistry reporting form. If you are also enrolled in the Pregnancy module, you must report the results obtained from the Pregnancy vials on the Pregnancy reporting form. On the Pregnancy module, you may report either urine or serum results.


CHEMISTRY, COMPREHENSIVE

Five liquid serum specimens per testing event, 5.0 mL, for the following analytes:


Alpha-Fetoprotein (AFP)

hCG (beta or intact)

Thyroid Stimulating Hormone (TSH)

Amylase

Iron

Thyroxine, Free (FT4)

Cortisol

Lactic Acid

Thyroxine, Total (TT4)

Creatine Kinase (CK or CPK)

Lactate Dehydrogenase (LD or LDH)

Triiodothyronine, Total (T3)

Direct Bilirubin

Lipase

T Uptake

Gamma Glutamyl Transferase (GGT)

Magnesium



Code the method and instrument from the list found in the General Instructions or the Addendum, which is included with each testing event.

Lactic Acid-Report results in mmol/L.


Lipase-Report results in U/L.


Magnesium-Report this analyte’s results on the proper line according to the units used - mg/dL or mEq/L.


Thyroxine, Free (FT4)-Report results in ng/dL. To convert pmol/L to ng/dL by multiplying by 0.0777.


Triiodothyronine, Total (T3)-Report results only in ng/mL. Divide ng/dL results by 100 to convert to ng/mL.


T-Uptake-Participants using the Abbott AxSYM, IMx or TDx; Roche fluorescence polarization method or the Roche Elecsys should report results on the TUp Units/TBI line.


CHEMISTRY, i-STAT

Five liquid specimens per testing event, 1.7 mL, for the following analytes:


Bicarbonate (CO2)

Hematocrit

pCO2

Calcium, Ionized

Hemoglobin

pO2

Chloride

Lactate

Potassium

Creatinine

Magnesium, Ionized

Sodium

Glucose

pH

Urea Nitrogen (BUN)


For CMS purposes, you must choose between i-STAT Chemistry and routine Chemistry for reporting analytes.In addition, for CMS purposes, you must choose between i-STAT Hemoglobin / Hematocrit and any routine Hematology Program.  We cannot report duplicate analytes between i-STAT and/or routine Chemistry / Hematology Program(s)


CHEMISTRY, i-STAT, WAIVED

Two liquid specimens per testing event, 1.7 mL, for waived cartridges


Bicarbonate (CO2)

Glucose


Calcium, Ionized

Hematocrit

Potassium

Chloride

Hemoglobin

Sodium

Creatinine

Lactate

Urea Nitrogen (BUN)

If using both waived and non-waived cartridges, you must purchase the 5-vial non-waived program. Do not report non-waived cartridges with the waived program.


CHEMISTRY, SPECIAL

Two liquid serum specimens per testing event, 5.0 mL, for the following analytes:


Ferritin

Pre-Albumin

T3, Free

Folate

Prolactin

Testosterone

Homocysteine

Prostate Specific Antigen(PSA), Total

Vitamin B12


Code reagents from the Instrument Master List on the back of the reporting form. Code instruments from the list found in the Addendum, which comes with the specimens.

Testosterone-Report results only in ng/dL. Multiply ng/mL results by 100 to convert to ng/dL.


CHEMISTRY, URINE/FLUIDS

Two liquid synthetic urine specimens and one liquid synthetic body fluid per testing event, 10.0 mL, for the following analytes:


Albumin ◊

Lactic Acid ◊

Sodium

Amylase

Lactate Dehydrogenase (LD/LDH) ◊

Total Protein

Calcium *

Magnesium *

Triglycerides ◊

Chloride

Osmolality *

Urea Nitrogen*

Cholesterol ◊

pH ◊

Uric Acid

Creatinine ◊

Phosphorus *


Glucose

Potassium *


                                       ◊ - Body Fluid only        * - Urine only


Only results from vials labeled “Urine/Fluids Chemistry” may be reported on the Chemistry, Urine/Fluids form. Do not report results from the “Basic & Comprehensive Chemistry” vials on this form.

Code reagents (which include method principles) from the list on the reporting form and instruments from the lists found in the Instrument Code list, which comes with the specimens.


◊ For urine creatinine and microalbumin, please enroll in the Urine Microalbumin/Creatinine program.  This program uses its own vials.  Be sure not to use the Urinalysis or Urine Microalbumin/Creatinine vials for Urine Chemistry testing.


Calcium - Results must be rounded to one decimal place and reported in mg/dL. To convert to mg/dL, multiply mmol/L by 4 and mEq/L by 2.


Creatinine - Vitros DT-60 participants using the 2-slide (ammonia-based) method should not report results based on diluted specimens if the diluted result is less than 7.5 mg/dL.


Electrolytes - Diluted or indirect ISE methods are those in which the sample is introduced to the electrode along with the diluent.  In undiluted or direct ISE methods, the sample is passed directly to the electrode without being diluted.  Undiluted methods tend to give higher readings, especially for sodium and chloride.  Because of this, correction factors may be employed to make undiluted methods agree with diluted ISE and flame photometer methods.  Use reagent codes labeled "diluted ISE" or "dil ISE" if you use a diluted method. Use reagent codes labeled "und ISE" for ISE methods with no diluent and use reagent codes labeled "und ISE/flame eq." for undiluted ISE methods with a flame photometer correction factor.

       



CHEMISTRY, WAIVED

Two liquid serum specimens per testing event, 5.0 mL, for the following analytes

NOTE: This is for waived instruments only. Cholestech users do not need to enroll in separate lipids analytes program:


Alanine Aminotransferase (ALT/SGPT)

Chloride

Phosphorous

Aspartate Aminotransferase (AST/SGOT)

Cholesterol, Total

Potassium

Albumin

Creatine Kinase, Total

Sodium

Alkaline Phosphatase

Creatinine

Triglycerides

Amylase

Glucose

Urea Nitrogen (BUN)

Bicarbonate (CO2)

HDL Cholesterol

Uric Acid

Bilirubin, Total

Lactate Dehydrogenase, Total


Calcium

Magnesium



Code reagent/instrument from the list on the reporting form. This program is compatible with the Abaxis Piccolo and the Cholestech.  For users of the Cholestech LDX, to insure uniformity of results and per manufacturer’s directions, you must be sure to change the sample type on the instruments Configuration Menu to “Serum”.  You must do so even if you routinely only run whole blood samples. Please do not forget to reset the instrument to “Whole Blood” once you are finished with proficiency testing.


Glucose - Do not report glucose values on the Chemistry, Waived form using visual strip tests or instruments (usually hand-held) that generate whole blood glucose values. Whole blood glucose values are not equivalent to serum glucose values. Many whole blood instruments, such as the Abbott Vision and the Roche Reflotron do give serum glucose results and should be reported on the Chemistry, Waived form. True whole blood glucose results can only be reported on specimens in the Whole Blood Glucose program.

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D-DIMER

Two liquid specimens per testing event, 1.0mL, for the analysis of D-Dimer

Note: Use Cardiac Markers Vials 1 and 2.

Specimens should be processed as a fresh patient sample. Test samples immediately on receipt. If testing cannot be performed within 24 hours of receipt, store samples at 2 to 8 degrees C. If samples are frozen, thaw samples completely at room temperature. Occasionally mix by gentle inversion. Do not heat sample to thaw.

Code your method using the list on the D-Dimer reporting form.  Qualitative or semi-quantitative results must be reported as 11 positive/ 10 negative. Report any value above the normal range for your assay as positive. Incompatible with Agen SimpliRed.


DRUG MONITORING, THERAPEUTIC

Five liquid serum specimens per testing event, 5 mL, for the following analytes:

Acetaminophen

Lithium

Theophylline

Carbamazepine

Phenobarbital

Tobramycin

Digoxin

Phenytoin

Valproic Acid

Gentamicin

Salicylates

Vancomycin


Salicylates-Report results in mg/dL. To convert mg/dL to ug/L, divide by 10.

Code reagents from the Method List on the reporting form. Code instrument from the Instrument Master List found in the General Instructions or Addendum, which is included with each testing event.


DRUG SCREENING, URINE

Two vials of synthetic, liquid urine per testing event, 10 mL, for the following analytes:


Drugs of Abuse Category

Minimum Target Concentrations

Alcohol (Ethanol)

0.050% or 50 mg/dL


Acetaminophen

0.4 μg/mL


Amphetamines (dl-Amphetamine, d-Methamphetamine)

1000 ng/mL


Barbiturates (Secobarbital)

300 ng/mL


Benzodiazepines (Diazepam)

300 ng/mL


Buprenorphine

20 ng/mL


Cannabinoids (11-nor-delta-9-THC-carboxylic acid)

100 ng/mL


Cocaine Metabolite (Benzoylecgonine)

300 ng/mL


Cotinine

200 ng/mL


Fentanyl

0.05 μg/mL


K2 Metabolite (UR-144)

20 ng/mL


LSD

0.5 ng/mL


6-MAM

20 ng/mL


MDMA (Ecstasy)

500 ng/mL


Methadone (Dolophine)

300 ng/mL


Methadone Metabolite

100 ng/mL


Methaqualone (Qualudes)

300 ng/mL


Methamphetamine

1000 ng/mL


Opiates (Morphine)

2000 ng/mL


Oxycodone

100 ng/mL


Phencyclidine (PCP)

25 ng/mL


Propoxyphene (Darvon)

300 ng/mL


Tramadol

500 ng/mL


Tricyclic Antidepressants (Amitriptyline)

1000 ng/mL


Zolpidem

0.08 μg/mL



When present, drugs are spiked at greater than the minimum target concentrations listed above.  These concentrations are not cut-off values.  Code method codes from the list on the reporting form. If your method does not discriminate among Amphetamine, Methamphetamine and/or MDMA, please report Amphetamine results only. Do not report Methamphetamine or MDMA. Similarly for Opiates, please report Opiates only if your method does not discriminate among Methadone, Oxycodone and/or Morphine.


FERTILITY ENDOCRINOLOGY

Two liquid serum specimens, 5.0 mL, per testing event for the following analytes:


DHEA-s

Estriol (unconjugated)

Follicle-Stimulating Hormone (FSH)

Estradiol

Progesterone

Luteinizing Hormone (LH)


Run Estradiol and Estriol testing as soon after receipt as possible.  If testing is to be delayed, the Fertility

Endocrinology samples must be frozen within 48 hours of receipt. Thaw samples completely at room temperature. Occasionally mix by gentle inversion. Do not heat sample to thaw.

Code reagents from the list on the reporting form. Code instrument from the Instrument Master list found in the General Instructions or Addendum, which is included with each testing event.


FRUCTOSAMINE

Two liquid serum specimens per testing event, 1.0 mL

Code reagents from the list on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event.

Report on the appropriate line of the reporting form, depending on whether your method is calibrated in μmol/L of glycated polylysine (pLys) or in mmol/L of 1-deoxy-1-morpholino-fructose (DMF). Samples are not compatible with the LXN Duet.


GLUCOSE, WHOLE BLOOD

Two (Basic) specimens per testing event, 1.0 mL

Five (Comp.) specimens per testing event, 1.0 mL

This material is a plasma based sample specifically formulated for whole blood instruments, small whole blood based glucometers. Instruments perform testing on both serum and whole blood should enroll in the Basic Chemistry module. Abbott i-Stat instruments should enroll in i-Stat Chemistry.


The samples uses special additives which mimics whole blood without the interferences found in hemolysate of fixed RBC based products. Allow the vials to stand for 15 minutes at room temperature (15-30 °C).  Mix vial gently by rolling between the palms of the hands for 20 seconds.  Gently invert 2 -3 times then repeat the rolling for 20 more seconds. Assay the specimens for glucose using the same procedures that you would use for patient finger-stick specimens.


Method codes are included on the reporting form(s) and must be reported each time for results to be peer graded.


GLUCOSE & HEMOGLOBIN, HEMOCUE, WAIVED

Two whole blood specimens per testing event, 2.0 mL.

The specimens must reach room temperature (15‐30°C) before being re-suspended. To re-suspend contents, roll the vials between the palms of the hands for 20 seconds in upright, then inverted positions. Place the vials on a mechanical mixer or gently invert manually for 5 minutes.


GLYCOHEMOGLOBIN, 2 vial

Two liquid hemolysate specimens per testing event, 1.0 mL.


GLYCOHEMOGLOBIN, 5 vial

Five liquid hemolysate specimens per testing event, 1.0 mL.


Make sure results are reported on the correct line according to method type – HbA1c, HbA1 or GHb.


CAP participants must enroll in the 5 vial program.


INSTRUCTIONS FOR USE

  1. Liquid 1.0 mL sample. Remove sample from refrigerator and mix by gentle inversion. Do not shake or mix mechanically.
  2. Refer to instrument or assay instruction manual for analyzing control material.
  3. After sampling, replace stopper and return to original package for maximum open vial stability at 2‐8 degrees C.

Specimens are to be processed as if they were whole (un-hemolyzed) blood, even though they will arrive without the cells intact.

For Tosoh instruments please follow your instruments procedure for running control material.

Code reagents from the list on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event with the specimens.


HEMOGLOBIN A1C, AFINION

Two liquid hemolysate specimens per testing event, 0.5 mL.

Samples are for hemoglobin A1C assay (HgbA1c) with Afinion by Axis Shield.

INSTRUCTIONS FOR USE

  1. Allow the sample to reach room temperature before use.  This takes about 30 minutes.
  2. Mix sample well by thoroughly shaking the vial for 30 seconds.
  3. Inspect the vial to ensure that the sample solution is homogenous.
  4. Analyze the sample using procedures described on page 2 (Specimen Collection) and page 3 (Running samples on the Analyzer) of your Afinion procedure manual.


HIGH SENSITIVITY (hs)-CRP

Two liquid specimens per testing event, 1.5 mL, for the analysis of hsCRP.

Note: use Cardiac Markers Vials 1 and 2.

Specimens should be processed as a fresh patient sample.  Samples should be tested immediately on receipt or stored refrigerated until testing is performed. If samples are frozen, thaw samples completely at room temperature. Occasionally mix by gentle inversion. Do not heat sample to thaw. Quantitative results are to be entered on the hsCRP reporting form. Code the method used by entering the appropriate code from the list on the form.


IMMUNOCHEMISTRY

Two lyophilized specimens per testing event, 2.0 mL, for the following analytes:


C-Peptide

Insulin

PTH

Vitamin D

Reconstitution instructions:

1.        Add 2.0 mL of deionized or distilled water to each vial with a volumetric pipette.

2.        Mix by gently swirling the vials followed by 2 to 3 gentle inversions.

3.        Allow to sit for 15 minutes and then gently swirl to ensure complete mixing.

4.        Inspect vials to make sure that all the material is dissolved. Full reconstitution should take no longer than 30 minutes

5.        PTH must be tested immediately upon reconstitution or kept frozen until ready to test. Insulin is good for 2 days when kept tightly stoppered at 2-8° C.


Code your reagent using the list on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event with the specimens.


LEAD, BLOOD, WAIVED

Two liquid hemolysate specimens per testing event, 6.0 mL, for blood lead.

Code reagent from the Reagent Code list on the form. For use with waived methods only. Not for CMS reporting.


LIPIDS

Five liquid serum specimens per testing event, 1.2 mL, for the following analytes:


Apolipoproteins A1 and B

HDL Cholesterol

LDL Cholesterol

Lipoprotein (a)


Code reagents from the list on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event.

For users of the Cholestech LDX, to insure uniformity of results and per manufacturer’s directions, you must be sure to change the sample type on the instruments Configuration Menu to “Serum”.  You must do so even if you routinely only run whole blood samples.  Please do not forget to reset the instrument to “Whole Blood” once you are finished with proficiency testing.

Lipids module is not compatible with the Abaxis Piccolo.


MICROALBUMIN/CREATININE, URINE

Two liquid synthetic urine specimens per testing event, 3.0 mL

For testing the following analytes:


Creatinine, Quant

Creatinine, Semi-quant

Microalbumin, Quant

Microalbumin, Semi-quant


This program uses its own vials.  DO NOT USE the Urinalysis or Urine Chemistry vials for Urine Microalbumin/Creatinine testing.

Code reagents from the lists on the reporting form; Code instrument from the list found in the General Instructions or Addendum, included with each testing event.



OXIMETRY, BLOOD

Five liquid specimens, 1.2 mL per testing event.

Specimens are for Carboxyhemoglobin, Methemoglobin, Oxyhemoglobin, and Total Hemoglobin measurements; compatible with all Oximetry instruments.


  1. Store at refrigerated temperatures 2 to 8 degrees C until ready to use.
  2. Blood Oximetry specimens should be analyzed immediately after removal from refrigeration.
  3. Before use, gently invert the ampule to mix the solution.
  4. Tap the ampule to restore the liquid to the bottom.
  5. Use gauze, tissue, gloves, or an appropriate ampule opener to protect fingers from cuts and open the ampule by snapping off the tip at the score.
  6. Immediately introduce the liquid from the ampule to the analyzer, following the instrument manufacturer's instructions for sampling a control material.
  7. Use direct aspiration, syringe transfer, or capillary mode techniques.


Code your instrument using the Method Codes list on the form.


p2PSA

Three liquid samples per testing event.  Intended for use with the Beckman Coulter p2PSA assay only.  

Specimens should be processed as a fresh patient sample.  Samples should be tested immediately on receipt or stored refrigerated until testing is performed. If samples are frozen, thaw samples completely at room temperature. Occasionally mix by gentle inversion. Do not heat sample to thaw.


PREGNANCY, SERUM or URINE (hCG)

Five liquid specimens per testing event, 1.0 mL

Samples are suitable for both serum and urine pregnancy kits. Only results from vials labeled “Pregnancy” may be reported on the Pregnancy form. Do not report results from the “Basic & Comprehensive Chemistry” vials on this form. Code your method using the list on the Pregnancy reporting form.


PREGNANCY, WAIVED

Two liquid specimens per testing event, 1.0 mL

Samples are suitable for urine pregnancy waived kits. Code your method using the list on the Pregnancy, Waived reporting form.


IRON BINDING CAPACITY

Two lyophilized serum specimens, 5.0 mL for the following analytes:


TIBC (Total Iron Binding Capacity)

UIBC (Unsaturated Iron Binding Capacity

Transferrin


Report the measured parameter only. Do not report both if one result is based solely on a calculation using total iron and the second answer.


1.        Add 5.0 mL reagent grade deionized water with a volumetric pipet.

2.        Invert occasionally until completely dissolved (do not shake or vortex).

3.        Let stand for 15 minutes after dissolution.

4.        Invert again prior to sampling.


Code reagents from the lists on the reporting form; Code instrument from the list found in the General Instructions or Addendum, included with each testing event.


SEX HORMONE BINDING GLOBULIN & TESTOSTEONE

Two liquid serum specimens, 5.0 mL, per testing event for the following analytes:


Sex Hormone Binding Globulin (SHBG)

Testosterone, Total

Testosterone, Bioavailable

Testosterone, Free


Refrigerate samples upon receipt.  Allow to come to room temperature before testing.

Report Testosterone in ng/dL only.  Multiply ng/mL results by 100 to convert to ng/dL.


TUMOR MARKERS

Two liquid serum vials, 2.0 mL, for the following analytes:


Beta-2-microglobulin

CA 19-9

CA-125

Prostate-Specific Antigen, (PSA) Free

CA 15-3

CA 27-29

Carcinoembryonic Antigen (CEA)

Prostatic acid phosphatase (PAP)


Tumor Markers should be tested immediately upon receipt. If delay in testing is anticipated, keep the samples frozen.  Once opened the samples are good for 5 days when kept tightly stoppered at 2-8 degrees C.

Code reagents from the lists on the reporting form; Code instrument from the list found in the General Instructions or Addendum, included with each testing event.