1. Ingeniería

International Catalog
2015
Proficiency Testing
Catalog
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Approved by: CMS, COLA, TJC, U.S. State Agencies
and International regulatory bodies. CAP accepted
analytes offered.
MLE International Distributors
COLOMBIA:
LABCARE DE COLOMBIA, LTDA
Autopista Medellín. Km 2.5, Vía Parcelas
Parque Empresarial Portos Sabana 80
Bodega 97
Cota, Colombia
Contact: Carlos Torres
Phone: +571-898-5202
Email: [email protected],
[email protected]
ECUADOR:
LABORATORIOS CLINICOS PAZMIÑO & NARVAEZ
Av. Gran Colombia # N14-65 y Hnos. Pazmiño
Quito, Ecuador
Contact: Dr. Lenin Villalta Guzman
Phone: 593 2 2569 911
E-mail: [email protected]
GUATEMALA:
BIO-NUCLEAR DE GUATEMALA, S.A.
Calzada La Paz 18-40, Zona 5
Ofibodegas Centro 5, Ofibodega # 29
01005 Guatemala, Guatemala
Contact: Jesús Ricardo Núñez, Andrea Michelle Sandoval
Phone/Fax: 502.2336.7766
E-mail: [email protected]
[email protected]
JAMAICA:
AVANT-GARDE FAMILY AND LABORATORY SERVICES
Columbus Plaza
Discovery Bay, St. Ann
Jamaica
Contact: Junior and Inez McIntosh
Phone: (876) 973-9236, Fax: (876) 670-0243
E-Mail: [email protected],
[email protected]
MALAYSIA:
ALL EIGHTS (M) SDN BHD (98420T)
45 Jalan TS 6/10A, Subang Industrial Park
47600 Subang Jaya
Selangor, Malaysia
Contact: May Thung
Phone: (60) 3 5633 4988
Fax: (60 ) 3 5633 0261
E-mail: [email protected]
Website: www.alleights.com.my
PANAMA:
INVERSIONES SAGRAV, S.A.
Urbanización Casa Blanca No. 24, Chanis
Panama City, Panama
Contact: Loyda Oduber
Phone: 507-233-0902/1825/3265
Fax: 507-399-6389
E-mail: [email protected], [email protected],
[email protected]
SINGAPORE:
ALL EIGHTS (SINGAPORE) PTE LTD
No. 6 Harper Road, #03-02/06-07 Leong Huat Building
Singapore 369674
Contact: Angela Law
Phone: 65-6288-6388
Fax: 65-6284-9805
Email: [email protected]
Website: www.alleight.com
TURKEY:
ONKOGEN DIAGNOSTIK SISTEMLER ILAC VE SAG.
Alacaatli Mah. 3300. Sk.
No:1/7 Yasamkent
Cankaya Ankara 06810
Turkey
Contact: Alper Soyler, Gozde Yildirim
Phone: 90 312 472 5277
Fax: 90 312 472 5717
Email: [email protected],
[email protected]
UAE/SAUDI ARABIA/QATAR/OMAN & INDIA:
SEQUENCE FZE
PO Box 31303
Level 41, Emirates Towers
Sheikh Zayed Road
Dubai, UAE
Contact: Product Specialist
Phone: +971 4 319 9163
Fax: +971 4 319 9165
Mobile: +971 55 9255466
Email: [email protected],
[email protected]
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
Table of Contents
Event Dates
MLE ships 3 times per year. Enroll anytime of the year.
After the first event, module pricing is pro-rated.
Overview
M1: February 2 • M2: May 11 • M3: September 14
Overview/How MLE Works . . . . . . . . . . . . . . . . . . . . . . . . . .1
Our Guarantee
Test Index and Module Descriptions
Test Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
If a specimen is missing, leaking, broken, not labeled,
hemolyzed, or crushed, and you contact us within three (3)
working days of receipt of your kit, we will provide a
replacement for the specimen(s) FREE of charge (limited to
material availability) or your lab will receive a grading
exception for that test.
Hematology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Blood Bank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Coagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
PPM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Urinalysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Microbiology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Immunology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Chemistry
Overview
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Lab Supplies & Services
. . . . . . . . . . . . . . . . . . . . .14
Online Result Reporting System—WDES . . . . . . . . . . . . .14
An essential tool for quality improvement, Proficiency Testing
(PT) was originally developed as an educational tool to help
laboratories investigate internal procedural problems and take
corrective action to minimize the effect on patient results.
Off-Schedule Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Ordering
Ordering Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Today, PT is the standard of competency most heavily weighed by
regulatory inspectors. MLE’s Proficiency Testing (PT) program is
designed for easy access, simple performance, and clear reporting.
Order Changes/Cancellations . . . . . . . . . . . . . . . . . . . . . . .15
CAP Accepted Analytes . . . . . . . . . . . . . . . . . . . . . . . . .16-17
Price Quote Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18-19
Proficiency Testing Order Form . . . . . . . . . . . . . . . . . . . . .20
PT is the practice of testing specimens of unknown values sent from
an outside source. After submitting your test results, you receive
data that compare your laboratory’s performance with that of other
labs that did the same procedures on the same specimens.
All tests in the MLE Program are included in the same shipment.
H o w M L E Wo r k s
1
2
3
4
5
6
7
MLE
Order
Order
Program
Kit
Test
Data
Evaluation
Catalog
Form
Verification
Guide
Shipments
Completion
Processing
Distribution
1 You receive a catalog
2 Complete the Order Form and send it to your
distributor
3 We process the order. You receive an Order
Verification
4 You download the program guide to prepare
for your first testing event
5 We send scheduled shipments of test kits
which include specimens to analyze in the
same way that you regularly test patient spec-
Medical Laboratory Evaluation 2015
8
imens. The kits are shipped from the U.S.
6 Upon completion of the testing, submit
results via online or by mail
7 MLE performs statistical compilation of all
participants’ results
8 You receive an evaluation report, graded
according to regulatory requirements, that
compares your performance with that of other
laboratories that used similar methods and
instrument.
www.acponline.org/mle
1
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
Test Index
CMS regulated analytes for CLIA purposes are in
bold type.
ABO Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Acetaminophen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Acetone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Affirm VPIII (DNA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Albumin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Alcohol, Serum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Alkaline Phosphatase . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Allergy Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 10
Alpha-fetoprotein (AFP) . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
ALT (SGPT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Ammonia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Amylase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Anti-dsDNA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Anti-HBc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Anti-HIV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Anti-RNP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Anti-RNP/Sm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Anti-SSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Anti-SSA/SSB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Anti-SSB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Anti-Sm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Anti-Streptolysin O (ASO) . . . . . . . . . . . . . . . . . . . . . . . .8, 10
Antibody Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Antimicrobial Susceptibility Testing . . . . . . . . . . . . . . . . .7
Antinuclear Antibody (ANA) . . . . . . . . . . . . . . . . . . . . . . . . .9
Apolipoprotein A1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Apolipoprotein B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
AST (SGOT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Beta (b)-2 Microglobulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Bilirubin, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11, 12
Bilirubin, Direct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12
Bilirubin, Neonatal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Blood Cell Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Blood Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Blood Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Blood Smear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
BNP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
C-Peptide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
CA 125 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
CA 15-3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
CA 19-9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
CA 27/29 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Calcium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Calcium, Ionized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12
Candida, Affirm VPIII(DNA) . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Carbamazepine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
CEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12, 13
C. difficile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Chlamydia (EIA/DNA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Chloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11, 12
Cholesterol, Total . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11, 12
CK-MB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
CMV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
CO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
2
www.acponline.org/mle
Colony Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Compatibility Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Complement C3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Complement C4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Cortisol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
C-Reactive Protein (CRP) . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 10
C-Reactive Protein, high sensitivity (HS-CRP) . . . . . . . . . . . . .9
Creatine Kinase (CK) . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Creatinine, Serum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Creatinine, Urine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Crossmatch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Cryptosporidium, Antigen Detection . . . . . . . . . . . . . . . . .8
Crystal Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
CSF Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
D-Dimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Dermatophyte Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
DHEA-S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Differential, Automated . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Digoxin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Drug Screen, Urine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Eosinophils, Nasal (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 6
Estradiol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Fecal Leukocytes (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 6
Fecal Occult Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Fecal Suspension, parasitology . . . . . . . . . . . . . . . . . . . . . .8
Fern Testing (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 6
Ferritin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Fibrinogen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Fluid Cell Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Folate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Fructosamine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
FSH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Gardnerella, Affirm VPIII (DNA) . . . . . . . . . . . . . . . . . . . . .8
GC (EIA/DNA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Genital Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 8
Gentamicin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
GGT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Giardia lamblia, Antigen Detection . . . . . . . . . . . . . . . . . .8
Glucose, serum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . .4, 6 10, 11, 13
Whole blood methods . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 6, 13
Glucose, urine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Glycohemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Gram Stain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 8
Gram Stain Morphology . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 8
HAV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
HBeAg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
HBsAb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
HBsAg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
hCG, serum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
hCG, urine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
HCV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
HDL Cholesterol . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11, 12
Hematocrit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 11
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 6, 11
Hemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 11
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 6, 11
Hemoglobin A1C (Glycohemoglobin) . . . . . . . . . . . . . . . . . . . .12
Homocysteine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
H. pylori, Antibody Detection . . . . . . . . . . . . . . . . . . . . . . . . . .10
Medical Laboratory Evaluation 2015
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
i-STAT Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Waived cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
IgA, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
IgE, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 10
IgG, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
IgM, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Infectious Mononucleosis . . . . . . . . . . . . . . . . . . . . . . . . . .8, 9
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Influenza A, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . .8
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Influenza B, Antigen Detection . . . . . . . . . . . . . . . . . . . . . .8
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Influenza A/B Combo, Antigen Detection . . . . . . . . . . . . . .8
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
INR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Iron . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
KOH Vaginal Prep (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 6
KOH Skin Prep (Slides) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 8
Lactic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12
LDH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
LDL Cholesterol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11, 12
Lead, Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Legionella, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . . .8
LH
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Lipase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Lithium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Lyme Disease Serology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Magnesium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Microalbumin, quantitative . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Microalbumin, urine dipstick . . . . . . . . . . . . . . . . . . . . . . . . . . .6
MRSA Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Mycoplasma, IgG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Myoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Nasal Eosinophils (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 6
NT-proBNP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Occult Blood, Fecal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Osmolality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Parasitology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Parathyroid hormone (PTH) . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Partial Thromboplastin Time (APTT) or (PTT) . . . . . . . .5
pCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
pH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Phenobarbital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Phenytoin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Phosphorus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Pinworms (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 6
Platelet Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
pO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Potassium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11, 12
Progesterone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Prolactin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Protein, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Prothrombin Time (PT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Whole blood methods (non-waived) . . . . . . . . . . . . . . . . .5
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Provider-Performed Microscopy (PPM) . . . . . . . . . . . . . . . . .5, 6
PSA, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12, 13
PSA, Free . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
PVA Slide, parasitology . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Red Blood Cell Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 5
Medical Laboratory Evaluation 2015
Respiratory Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Reticulocyte Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Rheumatoid Factor (RA) . . . . . . . . . . . . . . . . . . . . . . .8, 9, 10
Rh Factor (D Type) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Rotavirus, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . . .8
RSV, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Rubella, IgG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 10
Salicylate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Scabies (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 6
Sedimentation Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 5
Sodium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10,11, 12
Sperm (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 6
Stool Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Strep A, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . . . . .7
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6, 7
Strep pneumoniae, Antigen Detection . . . . . . . . . . . . . . . .8
Syphilis Serology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 10
T3, Free . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
T3, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
T3, Uptake . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
T4, Free . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
T4, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
tCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Testosterone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Theophylline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Throat Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Thyroglobulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Thyroglobulin antibody . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Thyroid Microsomal antibody . . . . . . . . . . . . . . . . . . . . . . . . . .13
TIBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Toxoplasma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Transferrin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Trichomonas, Affirm VPIII (DNA) . . . . . . . . . . . . . . . . . . . . . . .8
Triglyceride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11, 12
Troponin I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Troponin T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
TSH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
UIBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Unexpected Antibody Detection . . . . . . . . . . . . . . . . . . . . . .5
Urea Nitrogen (BUN) . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Uric Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11
Urine Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Urine Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Urine Dipstick . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Urine Drug Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Urine hCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Urine Sediment Identification . . . . . . . . . . . . . . . . . . . . . . . . . .6
Valproic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Vancomycin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Vitamin B12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Vitamin D, 25-Hydroxy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Waived and PPM packages . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Wet Mount Preparations (PPM) . . . . . . . . . . . . . . . . . . . . . . .5, 6
White Blood Cell Count . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 5
Wound Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
www.acponline.org/mle
3
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
Hematology
225 Hematology with 3-part Differential
Note: Module descriptions within each category are NOT listed
in numerical order. They are grouped by the type of test.
Please pay close attention to instrument
compatibility notes when selecting hematology
modules.
Questions? Contact your distributor.
See “Hematology Instrument List” online at
www.acponline.org/mle/enroll.htm and scroll to
“Forms.”
Includes 211 and 230.
Platelet Count
Red Blood Cell Count
White Blood Cell Count
Automated Differential
Hematocrit
Hemoglobin
Platelet Count
Red Blood Cell Count
White Blood Cell Count
226 Hematology with 5-part Differential
Compatible with most Beckman–Coulter 5-part
differential instruments EXCEPT for the AcT 5diff
(see 228).
Automated Differential
Hematocrit
Hemoglobin
Platelet Count
Red Blood Cell Count
White Blood Cell Count
228 Hematology with 5-part Differential
Compatible with Beckman Coulter AcT 5diff and ABX
Pentra 5-part differential instruments.
211 Basic Hematology
Five challenges each.
Hematocrit
Hemoglobin
Platelet Count
Five challenges each.
Five challenges each.
210 Hematology Module
Blood Cell Identification
Hematocrit
Hemoglobin
Compatible with most 3-part differential instruments.
Sysmex users see 224.
Red Blood Cell Count
White Blood Cell Count
212 Hemoglobin/Hematocrit
Five challenges each.
Automated Differential
Hematocrit
Hemoglobin
Platelet Count
Red Blood Cell Count
White Blood Cell Count
229 Sysmex with 5-part Differential
Five challenges each.
Compatible with most Sysmex 5-part differential
instruments only.
213 Hemoglobin/Hematocrit—Waived
Five challenges each.
For waived methods only.
Automated Differential
Hematocrit
Hemoglobin
Two challenges each.
Platelet Count
Red Blood Cell Count
White Blood Cell Count
215 Hemoglobin/Glucose
230 Blood Cell Identification (Add-On)
For HemoCue only.
Same as 231.
Two challenges each.
Only available with 223 through 229.
223 Hematology with 5-part Differential
Compatible with most Abbott CELL-DYN 5-part
differential instruments only.
Five challenges each.
Automated Differential
Hematocrit
Hemoglobin
Platelet Count
Red Blood Cell Count
White Blood Cell Count
224 Sysmex with 3-part Differential
Compatible with Sysmex 3-part automated differential
instruments only.
4
Stand-alone module.
Five challenges consisting of color
photographs.
240 Reticulocyte Count
Compatible with automated and manual reticulocyte
counting methods. Not for use with brilliant cresyl
blue staining methods.
Two challenges.
247 Sedimentation Rate
Five challenges each.
Automated Differential
Hematocrit
Hemoglobin
231 Blood Cell Identification
Platelet Count
Red Blood Cell Count
White Blood Cell Count
www.acponline.org/mle
Not for use with Sedimat 15 / 15 Plus
Two challenges.
CAP accepted analytes
Medical Laboratory Evaluation 2015
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
324 Roche CoaguChek XS INR
248 Sedimat 15 ESR
Compatible with the Polymedco Sedimat 15 / 15 Plus
instruments only.
Two challenges.
Two challenges.
INR
328 i-STAT Prothrombin Time
250 Fluid Cell Count/Crystals
Compatible with the i-STAT instruments only.
Fluid for Hemocytometer cell count and color photographs for identification of crystals.
Five challenges each.
Prothrombin Time
INR
Two challenges each.
Crystal Screening
RBC Count
330 CoaguChek XS Plus Prothrombin Time
WBC Count
For CoaguChek XS Plus only.
Five challenges each.
Prothrombin Time
Blood Bank
INR
331 CoaguChek XS Plus Prothrombin Time—Waived
For CoaguChek XS Plus only.
Two challenges each.
450 Rh Factor (D Type)
For Slide Methods ONLY.
Prothrombin Time
INR
Five challenges.
451 ABO & Rh Factor (D Type)
Provider-Performed
Microscopy
Not for use with slide methods.
Five challenges each.
452 Blood Bank 1
Not for use with slide methods.
Five challenges each.
534 Provider-Performed Microscopy (PPM)
ABO Group
Rh Factor (D Type)
Unexpected Antibody Detection
453 Blood Bank 2
Not for use with slide methods.
Five challenges each.
ABO Group
Antibody Identification
Compatibility Testing
(Crossmatch)
Rh Factor (D Type)
Unexpected Antibody
Detection
Vaginal Wet Mount Preparations (M1,M2,M3)
Nasal Eosinophils (M1,M2,M3)
Vaginal KOH Preparations (M1,M3)
Fecal Leukocytes (M2,M3)
Pinworms (M1,M2)
FERN testing (M1,M3)
Scabies (M1,M2)
Sperm (M2,M3)*
Six challenges total per shipment as
indicated in parentheses above.
Coagulation
*Sperm examination is not required by CAP.
535 Provider-Performed Microscopy (PPM)—Add-On
320 Coagulation Module
Requires 1-mL pipette (see item 121 on page 15).
Five challenges each.
Prothrombin Time
Partial Thromboplastin Time
Color photographs depicting microscopic fields for the
examination of:
Same as 534. Only available with 530, 531, 532, 541.
538 KOH Slides
Fibrinogen
INR
Two fixed glass slides for determining the presence or
absence of fungal elements in skin scrapings.
Two challenges.
321 Prothrombin Time
Requires 1-mL pipette (see item 121 on page 15).
Five challenges each.
Prothrombin Time
INR
Medical Laboratory Evaluation 2015
CAP accepted analytes
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5
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
Urinalysis
540 Urine hCG (Add-On)
Same as 541.
Only available with 530, 531.
530 Urinalysis Module
541 Urine hCG
Includes modules 531 and 532.
One challenge each unless otherwise noted
in parentheses.
Bilirubin
pH
Blood/Hemoglobin
Protein
Nitrite
Specific Gravity
Glucose
Microalbumin
Ketones
(dipstick only)
Urobilinogen
Leukocyte Esterase
Urine Sediment Identification (2)
531 Urinalysis Dipstick
Stand-alone module.
One challenge.
901 Waived and PPM Package
Number of challenges noted in parentheses.
Fecal Occult Blood* (2)
Urine hCG (1)
Hemoglobin (2)
Urine Sediment (2)
Hematocrit (2)
Strep A Antigen
PPM (6)
Detection (2)
Urinalysis (1)
Whole Blood Glucose (2)
*Fecal occult blood testing is not required by CAP.
hCG not included.
One challenge each.
Bilirubin
Blood/Hemoglobin
Nitrite
Glucose
Ketones
Urobilinogen
pH
Protein
Specific Gravity
Microalbumin
(dipstick only)
Leukocyte Esterase
532 Urine Sediment Identification
Two challenges consisting of color
photographs.
902 Basic Waived and PPM Package
Number of challenges noted in parentheses.
Fecal Occult Blood* (2)
Urinalysis (1)
PPM (6)
Urine hCG (1)
Strep A Antigen
Urine Sediment (2)
Detection (2)
Whole Blood Glucose (2)
*Fecal occult blood testing is not required by CAP.
533 Urine Sediment Identification (Add-On)
Same as 532. Only available with 531, 534, 541.
536 Urine Microalbumin/Creatinine (Add-On)
Same as 539. Only available with 530, 531, 541, 872.
539 Urine Microalbumin/Creatinine
Stand-alone module.
Compatible with quantitative and semi-quantitative
(dipstick) methods.
One challenge each.
537 Fecal Occult Blood (Add-On)
Same as 542.
Only available with 530, 531, 532, 534, 541.
542 Fecal Occult Blood
Stand-alone module.
Designed to allow the reporting and evaluation of
results for as many as four different testing personnel
or test kits.
Two challenges.
6
www.acponline.org/mle
CAP accepted analytes
Medical Laboratory Evaluation 2015
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
Microbiology
648 Colony Count*
*This module is for Colony Count ONLY!
No presumptive identification may be submitted for
this module.
The specimens included may contain dangerous pathogens
and must be treated with extreme care. These specimens
must be handled and disposed of only by personnel
trained to work with pathogenic microorganisms.
630 Bacteriology 1
For presumptive identification, order module 647.
Two challenges.
649 Urine Presumptive ID/Strep A Antigen
Detection
Best suited for urine paddle-dipping methods.
Consists of each of the following:
Urine Culture (1)
Gram Stain (2)
Antimicrobial
Throat Culture (1)
Genital Culture (1)
Susceptibility Testing (1)
Gram Stain Morphology (2)
Plus, an additional three challenges from the
following sources: blood, CSF, wound, respiratory,
and/or stool for a total of 6 cultures each shipment.
640 Bacteriology 2
Urine Culture (2)
Strep A Antigen
Throat Culture (2)
Detection (1)
Gram Stain (2)
Antimicrobial
Genital Culture (1)
Susceptibility Testing (1)
Gram Stain Morphology (2)
Presumptive
Colony Count (2)
Identification (2)
Antimicrobial
Gram Stain (1)
Susceptibility Testing (1)
(directly from
Strep A Antigen
sample provided)
Detection (5)
Gram Stain Morphology (1)
652 Urine Presumptive ID/Throat Culture
Best suited for urine paddle-dipping methods.
Presumptive
Identification (2)
Gram Stain (1)
(directly from
sample provided)
Colony Count (2)
Antimicrobial
Susceptibility Testing (1)
Throat Culture (3)
Gram Stain
Morphology (1)
650 Gram Stain
643 Urine Culture
Five fixed glass slides.
Urine Culture (5)
Gram Stain (1)
Antimicrobial
Gram Stain
Susceptibility Testing (1)
Morphology (1)
Five challenges each.
Gram Stain
Gram Stain Morphology
641 Throat Culture
644 Urine Culture/Strep A Antigen Detection
Not suitable for Strep A kits.
Urine Culture (2)
Strep A Antigen
Gram Stain (1)
Detection (3)
Antimicrobial
Gram Stain
Susceptibility Testing (1)
Morphology (1)
Five challenges.
642 Throat Culture/Strep A Antigen Detection
Throat Culture (2)
Strep A Antigen
Detection (3)
645 Urine/Throat Culture
Urine Culture (3)
Throat Culture (2)
Gram Stain (1)
Antimicrobial
Gram Stain Morphology (1) Susceptibility Testing (1)
660 Strep A Antigen Detection
Not suitable for culture.
Five challenges.
647 Urine Presumptive ID/Colony Count
662 Strep A Antigen Detection—Waived
Best suited for paddle-dipping methods.
Presumptive
Colony Count (2)
Identification (5)
Antimicrobial
Gram Stain (1)
Susceptibility Testing (1)
Gram Stain Morphology (1)
For waived Strep A Antigen Detection kits only.
Two challenges.
646 Genital Culture
Genital Culture (5)
Gram Stain (1)
Gram Stain Morphology (1)
Medical Laboratory Evaluation 2015
CAP accepted analytes
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7
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
654 Genital Culture (Add-On)
681 Respiratory Antigen Detection
Same as 646. Only available with 641 through 645,
647, 649, 650, 652, 660, 670.
Genital Culture (2)
Gram Stain (1)
Gram Stain
Morphology (1)
Five challenges each.
Influenza A
Influenza B
Influenza A/B Combo
RSV
682 C. difficile/Rotavirus Antigen Detection
Five challenges each.
668 Affirm VP III (DNA)
Five challenges each.
Candida sp.
Gardnerella vaginalis
Trichomonas vaginalis
C. difficile Toxin/
Common Antigen
Rotavirus
683 Giardia lamblia/Cryptosporidium Antigen
Detection
670 Chlamydia (EIA, DNA)
Five challenges.
Five challenges each.
Cryptosporidium
Giardia lamblia
675 Chlamydia/GC (EIA, DNA)
Five challenges each.
Chlamydia trachomatis
686 Legionella Antigen Detection
Neisseria gonorrhoeae
673 Chlamydia (EIA, DNA)—Add-On
For use with the Binax NOW Legionella Urinary
Antigen Detection kits only.
Five challenges.
Same as 670. Only available with 630 through 647,
649, 650, 652, 660.
Two challenges.
687 Streptococcus pneumoniae Antigen Detection
For use with the Binax NOW Streptococcus pneumoniae
Urinary Antigen Detection kit only.
Five challenges.
Note
• All urine culture specimens are suitable for
presumptive identification (ie, growth/no growth,
Gram stain interpretation) and/or definitive
identification (ie, genus and/or species).
• The number of challenges is noted in parentheses.
678 Dermatophyte Screen
690 Parasitology
Provides five challenges from among the following:
PVA Slide (for permanent stain), Fecal Suspension
(direct wet mount examination for ova and parasites),
Blood Smear for Parasites.
691 Parasitology 2
Appropriate for determining the presence or absence
of dermatophytes.
Two challenges.
Fecal Suspension (4)
Blood Smear (1)
695 MRSA Screening
Screening for the prescence or absence of methicillinresistant Staphylococcus aureus only.
538 KOH Slides
Two fixed glass slides for determining the presence or
absence of fungal elements in skin scrapings.
Two challenges.
Five challenges.
Immunology
680 Respiratory Antigen Detection—Waived
Two challenges each.
Influenza A
Influenza B
Influenza A/B Combo
RSV
750 Immunology Module
Five challenges each.
Infectious Mononucleosis
Rheumatoid Factor
8
www.acponline.org/mle
CAP accepted analytes
Anti-Streptolysin O
(ASO)
Medical Laboratory Evaluation 2015
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
751 Rheumatology Module
779 Antinuclear Antibody (ANA)-Add-On
Includes 763 and 764.
Same as 767.
C-Reactive Protein (2)
Rheumatoid Factor (5)
Not for high-sensitivity methods
For non-latex methods ONLY.
755 Infectious Mononucleosis—Waived
Only available with 751.
782 ANA Expanded
For waived Infectious Mononucleosis kits only.
For non-latex methods ONLY.
Two challenges.
Five challenges each.
ANA
Anti-dsDNA
Anti-RNP
Anti-RNP/Sm
762 Infectious Mononucleosis
Five challenges.
761 Infectious Mononucleosis/Rheumatoid Factor
Anti-SSA
Anti-SSB
Anti-SSA/SSB
Anti-Sm
783 ANA Expanded (Add-On)
Includes 762 and 763.
Same as 782. Only available with 750, 751.
Five challenges each.
For non-latex methods ONLY.
763 Rheumatoid Factor
784 Complement/Immunoglobulins
Five challenges each.
Five challenges.
C3
C4
IgA, Total
764 C-Reactive Protein (CRP)
Not for high-sensitivity methods.
Two challenges.
IgG, Total
IgM, Total
771 Rubella
For lgG methods only.
776 C-Reactive Protein (CRP)—Add-On
Five challenges.
Not for high-sensitivity methods.
Only available with 750.
772 Syphilis Serology
Five challenges each.
765 High-Sensitivity C-Reactive Protein (HS-CRP)
Two challenges.
777 High-Sensitivity C-Reactive Protein
(HS-CRP)—Add-On
MHA-TP
RPR
TPA
VDRL
789 diagnostics direct Syphilis Health Check
Five challenges each.
TPA - For the Syphilis Health Check ONLY.
RPR - For use with any RPR methods.
Only available with 750, 751.
Two challenges.
770 Specific Allergen Testing
766 Antinuclear Antibody (ANA)
Number of challenges noted in parentheses.
For Latex methods ONLY.
Includes 2 sets of samples for large volume requirements.
Five challenges.
Does not include Total IgE.
Allergen Specific IgE (14)
778 Antinuclear Antibody (ANA)—Add-On
Same as 766.
For Latex methods ONLY. Only available with 751.
767 Antinuclear Antibody (ANA)
For non-latex methods ONLY.
Five challenges.
740 Additional Specific Allergen Material
Includes 1 additional set of samples for large volume
requirements.
Only available with 773.
Allergen Specific IgE (14)
773 Diagnostic Allergy
Number of challenges noted in parentheses.
Allergen Specific IgE (14)
Medical Laboratory Evaluation 2015
CAP accepted analytes
Total IgE (5)
www.acponline.org/mle
9
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
912 Rubella/Toxoplasma/CMV Combo
774 Lyme Disease Serology
Two challenges.
Includes 771, 786 and 788
Anti-Borrelia burgdorferi
Five challenges for Rubella. Two challenges
for Toxo and CMV.
775 Viral Markers
Five challenges each.
HBsAb
Anti-HIV
HAV
HCV
Chemistry
HBsAg
HBeAg
Anti-HBc
Chemistry Ordering Tips
780 H. pylori Antibody Detection
• If you use the i-STAT instrument, select modules 817,
818, or 832 which are specifically for i-STAT instruments.
Two challenges.
Please pay close attention to instrument compatibility
notes when selecting any of the chemistry modules.
If you need further assistance, contact your distributor.
781 Mycoplasma
IgG only.
Two challenges.
786 Toxoplasma IgG/IgM
811 Cholestech Waived Chemistry
Two challenges.
For the LDX Cholestech Instrument (Waived testing
ONLY).
788 CMV IgG/IgM
Two challenges each.
Two challenges.
ALT (SGPT)
AST (SGOT)
Cholesterol, Total
LDL Cholesterol - Calculated
790 Anti-HIV—Waived
For waived HIV kits only.
Two challenges.
Anti-HIV1
812 Piccolo Waived Chemistry
Anti-HIV 1/2
For the Abaxis Piccolo Instrument (waived cartridges
ONLY).
791 Anti-HIV
Two challenges each.
Five challenges.
Anti-HIV1
Glucose
HDL Cholesterol
Triglyceride
Albumin
Alkaline Phosphatase
ALT (SGPT)
Amylase
AST (SGOT)
Calcium
Chloride
Cholesterol
Anti-HIV 1/2
905 Syphilis/Viral Marker Combo
Includes 772 and 775
Five challenges.
909 Immunology Combination
Includes 750, 764, and 773
Five challenges unless noted in parentheses.
Infectious mononucleosis Anti-streptolysin O (ASO)
Rheumatoid factor
C-Reactive Protein (CRP) (2)
Allergen specific IgE (14) Total IgE
CO2
Phosphorus
Creatine Kinase Potassium
(CK)
Sodium
Creatinine
Total Bilirubin
GGT
Total Protein
Glucose
Triglyceride
HDL Cholesterol Urea Nitrogen
LDL Cholesterol Uric Acid
- Calculated
817 i-STAT Chemistry 1
Five challenges.
For i-STAT analyzer only. Includes 818 and 847.
910 Inflammatory Module
Five challenges unless noted in parentheses.
Anti-Streptolysin O (ASO) Rheumatoid Factor
C-Reactive Protein (2) – Not for high-sensitivity methods
10
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CAP accepted analytes
Medical Laboratory Evaluation 2015
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
818 i-STAT Chemistry 2
820 Chemistry 2
For i-STAT analyzer only.
Five challenges each.
Five challenges each.
Total Bilirubin
Chloride
Cholesterol, Total
CO2
Creatinine
Chloride
Creatinine
Glucose
Hematocrit
Hemoglobin
Ionized Calcium
Potassium
Sodium
tCO2
Urea Nitrogen
821 Chemistry 3
832 i-STAT Chemistry—Waived
Five challenges each.
For i-STAT analyzer (Waived cartridges only).
Total Bilirubin
Chloride
Cholesterol, Total
CO2
Creatinine
Glucose
HDL Cholesterol
Two challenges each.
Chloride
Creatinine
Glucose
Hematocrit
Hemoglobin
Glucose
Potassium
Sodium
Urea Nitrogen
Uric Acid
Ionized Calcium
Potassium
Sodium
tCO2
Urea Nitrogen
LDL Cholesterol Calculated
LDL Cholesterol Direct
Potassium
Sodium
Triglyceride
Urea Nitrogen
Uric Acid
810 Chemistry Module
Includes CMP, BMP, hepatic, thyroid and lipid profiles.
834 Additional Chemistries
Stand alone module.
Includes 821, 822, 823, 825, 827, 842.
Five challenges each.
Five challenges.
Albumin
Calcium
Iron
Lactic Acid
Magnesium
Phosphorus
813 Comprehensive Metabolic Panel
Includes 814, 816, 822.
Five challenges.
Total Protein
TIBC - Calculated
TIBC - Direct
UIBC - Direct
Uric Acid
814 Basic Metabolic Panel
822 Chemistry (Add-On)
Five challenges each.
Calcium
Chloride
CO2
Creatinine
Same as 834.
Only available with 814, 815, 819-821, 824, 826, 830.
Glucose
Potassium
Sodium
Urea Nitrogen
Albumin
Calcium
Iron
Lactic Acid
Magnesium
Phosphorus
815 Hepatic Profile
Five challenges each.
Albumin
Alkaline Phosphatase
ALT (SGPT)
AST (SGOT)
Direct Bilirubin
Total Bilirubin
Total Protein
823 Enzyme Chemistry (Add-On)
Only available with 813, 814, 815, 819–821, 824, 826, 830,
834.
816 Hepatic Profile (Add-On)
Same as 815. Only available with 814, 819-821, 824,
826, 830, 834.
819 Chemistry 1
ALT (SGPT)
Alkaline Phosphatase
Amylase
AST (SGOT)
Creatine Kinase (CK)
GGT
LDH
Lipase
824 Thyroid Profile
Five challenges each.
Cholesterol, Total
Glucose
Total Protein
TIBC - Calculated
TIBC - Direct
UIBC - Direct
Uric Acid
Five challenges each.
Urea Nitrogen
Potassium
Medical Laboratory Evaluation 2015
Alpha-fetoprotein (AFP)
Cortisol
Free T3
Free Thyroxine (T4)
CAP accepted analytes
T3 Uptake
Thyroxine (T4)
Triiodothyronine (T3)
TSH
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11
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
843 Direct Bilirubin
825 Thyroid Profile (Add-On)
Same as 824. Only available with 813–815, 819–821,
826, 830, 834, 862.
Five challenges.
845 Cardiac Markers
Five challenges each. Quantitative only.
826 Lipid Profile
Five challenges each.
Cholesterol, Total
HDL Cholesterol
LDL Cholesterol Calculated
LDL Cholesterol Direct
Triglyceride
BNP
CK-MB
D-Dimer
Myoglobin
NT-proBNP
Troponin I
Troponin T
846 BNP/D-Dimer
B-type Natriuretic Peptide
827 Lipid Profile (Add-On)
Same as 826. Only available with 813-815, 819, 824, 830,
834.
Two challenges.
BNP
D-Dimer
NT-proBNP
829 Apolipoproteins
847 Blood Gases
Two challenges each.
Apolipoprotein A1
Apolipoprotein B
Five challenges each.
830 Therapeutic Drug Monitoring
Five challenges each.
Acetaminophen
Carbamazepine
Digoxin
Gentamicin
Lithium
Phenobarbital
Phenytoin
Salicylate
Compatible with the i-STAT analyzer as well as other
blood gas instruments.
Theophylline
Valproic Acid
Vancomycin
Chloride
Ionized Calcium
Lactic Acid
pCO2
pH
pO2
Potassium
Sodium
850 Glycohemoglobin
NOT compatible with Afinion analyzer.
831 Therapeutic Drug Monitoring (Add-On)
Two challenges.
Same as 830. Only available with 810, 813–815,
819–821, 824, 826, 834.
Two challenges.
835 Serum Alcohol/Acetone
Five challenges.
855 Fructosamine
NOT compatible with the LXN Test System.
836 Ammonia
Two challenges.
Two challenges.
859 PSA (Add-On)
837 Blood Lead
Same as 861. Only available with 860.
Five challenges.
860 Endocrinology/Hematology/Oncology
838 Blood Lead—Waived
Two challenges each.
Two challenges.
841 Neonatal Bilirubin
Five challenges each.
Direct Bilirubin
851 Afinion Glycohemoglobin
Total Bilirubin
842 Direct Bilirubin (Add-On)
Same as 843.
Only available with 814, 819–821, 824, 826.
CEA
DHEA-S
Estradiol
Ferritin
Folate
FSH
Homocysteine
LH
Progesterone
Prolactin
Testosterone
Transferrin
Vitamin B12
861 PSA
Two challenges.
12
www.acponline.org/mle
CAP accepted analytes
Medical Laboratory Evaluation 2015
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
862 Tumor Markers
872 Urine Chemistry
Two challenges each.
Beta (b)-2 Microglobulin
CA 125
CA 15-3
CA 19-9
Two challenges each.
CA 27/29
CEA
Free PSA
PSA
Thyroglobulin
Amylase
Calcium
Chloride
Creatinine
Glucose
Magnesium
Osmolality
863 Endocrinology 2
Lyophilized samples. 2 ml volumetric pipette required
for reconstitution.
Two challenges each.
C-Peptide
Insulin
Parathyroid hormone
(PTH)
Vitamin D, 25-Hydroxy
864 Thyroid Antibodies
Thyroid Microsomal
Antibody (Anti-TPO)
Designed to allow the reporting and evaluation of
results for as many as five different testing personnel
or glucose meters.
Five challenges.
For waived methods only. Designed to allow the
reporting and evaluation of results for as many as five
different testing personnel or glucose meters.
Two challenges.
865 Serum hCG
Five challenges.
906 Thyroid/Immunoassay/Tumor Marker Combo
Includes 824, 860, and 862
866 Serum hCG (Add-On)
Same as 865. Only available with 810, 813, 814, 815,
819, 820, 821, 824, 826, 834.
867 Urine Drug Screen
Two challenges for the qualitative detection
of drugs in urine.
Cannabinoids
870 Whole Blood Glucose
871 Whole Blood Glucose—Waived
Two challenges each.
Thyroglobulin Antibody
Phosphorus
Potassium
Sodium
Specific Gravity
Total Protein
Urea Nitrogen
Uric Acid
Five challenges for Thyroid assays.
Two challenges for Immunoassays and
Tumor Markers.
907 Thyroid/Immunoassay/Tumor Marker/Serum hCG Combo
Includes 824, 860, 862, and 865
Five challenges for hCG and Thyroid
assays.
Two challenges for Immunoassays and
Tumor Markers.
Opiates
868 Urine Drug Screen
Two challenges each.
For the qualitative detection of drugs in urine. 10ml each.
Each challenge will include one or more of the following:
Acetaminophen
Amphetamines
Barbiturates
Benzodiazepines
Buprenorphine
Cannabinoids (THC)
Cocaine Metabolites
Cotinine
EDDP
Ethanol (Alcohol)
LSD
MDMA
Methadone
Methamphetamines
Methanol
Methaqualone
6-Monoacetylmorphine
Opiates (Morphine
Trihydrate)
Oxycodone
Phencyclidine
Propoxyphene
Tricyclic Antidepressants
Medical Laboratory Evaluation 2015
908 Immunoassay/Tumor Marker Combo
Includes 860 and 862
Two challenges.
913 Immunoassay/Tumor Marker/hCG Combo
Includes 860, 862, and 865
Five challenges for hCG assays.
Two challenges for Immunoassays and
Tumor Markers.
CAP accepted analytes
www.acponline.org/mle
13
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
Lab Supplies & Services
SUPPLIES
121 Pipette—1mL
For use with 320 and 321. Reusable Class A volumetric pipette required for reconstitution of lyophilized
proficiency testing specimens.
126 Pipette Pump
For use with product 121 above.
SERVICES
107 Hard Copy of Participant Summary for the Year
108 Additional Program Binder
116 Automatic Program Renewal . . . . . . . . . . . . . . . .FREE
Free yourself from re-enrollment/re-ordering hassles. We’ll do it for you! To enroll, add module 116 to your order.
WEB DATA ENTRY SYSTEM (WDES)
Online Result Reporting Program . . . . . . . . . . . . . . . .FREE
To register or receive more information, send an e-mail to [email protected].
14
www.acponline.org/mle
Medical Laboratory Evaluation 2015
2015 SHIP DATES M1: Feb. 2 • M2: May 11 • M3: Sept. 14
PT Order Form
Instructions
Enroll in MLE by December 12, 2014, to ensure you
receive shipments for the entire year. You may enroll any
time after the first event at a prorated cost depending on
the availability of specimens.
Using the PT Order Form
Formulate Your Order
Review the catalog to determine the products which best
meet your proficiency testing (PT) needs.
Note any instructions that refer to specific regulatory
requirements or instrument/method compatibility. Choose
the product most appropriate for your testing needs.
Please pay close attention to instrument compatibility notes when selecting hematology modules and
coagulation modules.
Next Step
Complete the PT order form (last page of catalog).
Photocopy the completed order form for your records.
Send the original form to your local MLE distributor.
Within a few weeks you should receive an Order
Verification.
Note: If there is no distributor listed for your
country/region, please contact MLE at [email protected]
for further instructions.
The MLE products you order may contain pathogenic
material. By returning the order form, you assume all risk
and responsibility in connection with the receipt, handling,
storage, use, and disposal of the products.
Changes/Cancellations
Requests are to be sent directly to your
local MLE distributor.
New Orders or Additions
All new orders must be submitted in writing to MLE. All
changes to an existing order must be submitted in writing
to MLE before they can be entered into the order processing system. Please send your order or order changes in
writing at least four weeks prior to the next shipping date
to avoid additional shipping fees. MLE ships three times
per year. You may enroll throughout the year.
Note: The MLE catalog lists prices for the full year. After
the first event, module pricing is prorated. If you add a
module less than four weeks prior to the next shipping
date, you MAY be subject to a “rush order” fee.
Cancelling a Module
If we receive your written request for cancellation of a module(s) at least four weeks prior to the next shipping date,
you will not be held accountable for payment of the module
for the remaining shipments. Unless otherwise requested,
we will credit your account for that amount and the credit
will be applied to additions to your order or toward enrollment for the next year.
If you cancel a module less than four weeks prior to
the next shipping date, you are financially responsible for the cost of the module for the next shipment.
You will NOT be financially responsible for subsequent
shipments. For example, you cancel (in writing) a module
on January 2, 2015. The first shipment (M1) is scheduled to
be shipped on February 2, 2015. You are responsible for the
cost of the module for M1 but not for M2 or M3.
Cancelling the Entire Order
We will refund any charges for unshipped specimens if we
receive notification in writing four weeks prior to the next
shipping date. Once we have shipped orders, we cannot
cancel the order or refund the cost. The annual
administration fee is non-refundable.
Medical Laboratory Evaluation 2015
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15
2015 MLE Proficiency Testing Order Form
1
Ⅺ New Enrollee
Ⅺ Renewing Participant: MLE ID # _________________________
4 Ship To:
Ⅺ Same as “bill to” address.
2 Bill To: (please clearly print or type)
Contact ________________________________________________
Contact ________________________________________________
Facility Name __________________________________________
Facility Name __________________________________________
Address ________________________________________________
_______________________________________________________
_______________________________________________________
Region/Province ________________________________________
Address ________________________________________________
_______________________________________________________
_______________________________________________________
Region/Province:________________________________________
Country________________________________________________
Phone ______________________Fax _______________________
Country________________________________________________
E-mail: ________________________________________________
Phone ______________________Fax _______________________
E-mail _________________________________________________
3 Lab Director ____________________________________
Ⅺ Activate Auto Renewal at no charge.
(see page 14 for details)
Module #
Description
Price
Ext.
Module #
Description
Price
Ext.
Please note: Cancel a module IN WRITING up to 4 weeks prior to the upcoming shipment to avoid being charged.
The MLE products you have ordered may contain pathogenic material. By returning this order form, you assume
all risk and responsibility in connection with the receipt, handling, storage, use, and disposal of the material.
16
www.acponline.org/mle
FOR MLE USE ONLY
Medical Laboratory Evaluation 2015
What’s New for 2015
NEW MODULES
Module No.
Description
Catalog Page No.
837
Blood Lead
13
838
Blood Lead – Waived
13
872
Urine Chemistry
13
MODULE RECONFIGURATIONS
Module No.
Description
Catalog Page No.
534, 535, 901, 902
Now contains Scabies
6
845
Now contains BNP,
NT-proBNP and D-Dimer
13
846
Now contains D-Dimer
13
860
Now contains DHEA-S
13
Proficiency Testing at its Best.
MLE4016