CHC Guide - 2020 - 14

Specialty Testing

HEADER
ONE STEP+ PREGNANCY
CASSETTE TESTS

ONESTEP PRO+ STREP A
CASSETTE KIT
* CLIA-waived
* Easy-to-use flip design; all-in-one extraction,
incubation, and test
* Results in 5-10 minutes
* Sensitivity of 96.2% and specificityof 98.7%
* External negative and positive controls included
* Made in the USA
(900-7570)..............................................25 tests/kit
CPT® Code: 87880QW†

ONESTEP+ STREP A TEST
STRIPS

Ultrasensitive: Studies have shown that sensitivity
of the OneStep+ Strep A Test and the standard
single-swab culture method are not statistically
different. Convenient, compact packaging with
everything you need to run 25 tests including
positive and negative controls.
* CLIA waived
* Sensitivity: 97%; specificity: 95%
* Room-temperature storage
* Canister packaging for ease of multiple testing
* Walk-away procedure
(107-4050).....................................................25/box
(570-0122).................................................... 50/box
CPT® Code: 87880QW†

* Urine test
* CLIA waived
* 25 mIU/mL detection level
* Sensitivity: 99%
* Room-temperature storage
25-Patient Kit
(900-4073)...........................................................ea

Contains: 25 pouched tests per kit & 1 package insert.
CPT® Code: 81025QW† (Urine)

ONE STEP+ PREGNANCY STRIP TESTS
Rapid, chromatographic immunoassay for the qualitative
detection of human chorionic gonadotropin (hCG) in
urine to aid in the early detection of pregnancy.
* Urine test
* CLIA waived
* 25 mIU/mL detection level
* Sensitivity: 99%
* Room-temperature storage
* Read time 3 minutes or less
(900-4072).................................................... 25/box
Contains: 25 pouched tests per kit & 1 package insert.
CPT® Code: 81025QW† (Urine)

ONE STEP+ PREGNANCY
COMBO CASSETTE TESTS
* Urine or serum test
* CLIA waived for urine only
* 25 mIU/mL detection level
* Sensitivity: 99%
* Room-temperature storage
25-Patient Kit
(900-4075).................................................... 25/box

Contains: 25 pouched tests per kit & 1 package insert.
CPT® Codes: 81025QW† (Urine); 84703† (Serum)

ONESTEP PRO+
MONONUCLEOSIS
TEST KIT

ONESTEP+ MONO
CASSETTE TEST
A rapid chromatographic-immunoassay for the
qualitative detection of infectious mononucleosis
in whole blood, serum, or plasma.
* CLIA waived
* Finger stick or collection tube
* Serum: sensitivity > 99%; specificity > 99%
* Plasma: sensitivity > 99%; specificity > 99%
* Whole blood: sensitivity 91%; specificity > 99%
* Room-temperature storage
* Includes controls
Complete Kit
(900-4070)................................................................................ 20/box
Contains: 20 pouched test devices with disposable sample droppers;
disposable, heparinized capillary tubes with dispensing bulb; 1 of each control
(positive & negative); 1 sample buffer; 1 procedure card & 1 package insert.
CPT® Code: 86308QW†

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CLIA waived for whole blood
No age restrictions
Serum/plasma: sensitivity > 99%; specificity > 99%
Whole blood: sensitivity > 99%; specificity 98.8%
Uses best technology of bovine derivatives, which eliminate cross reactivity
Room temperature or refrigerated storage
Two internal controls exist to avoid additional cost and ensure good
laboratory practice
* Measures heterophile antibodies in whole blood, serum and plasma
* Only 25 µL blood needed
* Made in the USA
#1125547, Mono Test Kit
(112-5547) ............................................................................................20/box
Contains: 20 test devices, 1 developer solution, 1 negative control, 1 positive control,
40 sample transfer pipettes (20 for serum/plasma & 20 for whole blood), 1 procedure
card & 1 package insert.

CPT® Codes: 86308QW† (Whole Blood) / 86308† (Serum/Plasma)

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CHC Guide - 2020

Table of Contents for the Digital Edition of CHC Guide - 2020
