Testing Devices

About CLIA

CLIA, or the Clinical Laboratory Improvement Amendments of 1988 are regulations that impose federal standards on all U.S. testing facilities or sites that use human specimens to diagnose, prevent, or treat disease. Under CLIA, there are different test complexity categories assigned to tests based on seven criteria scored by CLIA including criteria such as risk for an incorrect result and sample specimen type. The most simple tests with the lowest risk for incorrect results are given the status of CLIA waived, and are therefore FDA cleared for home use.

Additionally, to use a CLIA waived machine, a site must only have a CLIA certificate and follow the manufacturer’s instructions on how to operate the test. Other CLIA requirements that apply to non-CLIA waived tests, such as inspections, certifications, and meetings of standards do not apply to CLIA waived tests. Therefore, getting started with and operating CLIA waived tests is a fairly simple process. For more information regarding CLIA, please visit here, and for more information on how to obtain a CLIA waiver, please visit here.

Abbot ID Now

What is it?

Abbott ID NOW™ by Abbott Point of Care Diagnostics is a device manufactured by Abbott Point of Care Diagnostics for molecular point-of-care tests such as COVID-19, influenza A & B, group A streptococcus, and Respiratory Syncytial Virus (RSV).

This device is CLIA waived for all tests, can store up to 999 patient test results, and provide output from results such as patient ID, user ID, date and time of test, and result.

How does it work?

ID NOW uses a liquid solution designed to deactivate the virus and break it apart to expose the RNA. The instrument then amplifies the virus hundreds of millions of times to make it more easily detectable and determine at a molecular level whether the sample is positive or negative.

How do I use it?

Nasal swab is taken
Swab is placed into an acidic solution and heated to 132.8 degrees F, exposing the virus
The device then amplifies the virus millions of times to make it detectable

How long will it take to obtain results?

If a positive sample is detected, the result will be visible in as little as 5 minutes. If a negative sample, the result will be visible in 13 minutes.

Key Features

This machine boasts reliable and rapid results for a variety of tests on the spot in a portable, 6.6 lb machine the size of a toaster.

Physician’s Immediate Care has named this device the “Gold Standard” of rapid molecular diagnostics.

Provides fast and reliable results for flu, strep, and RSV since 2014.

This machine can perform tests for:

Covid-19
Influenza A & B
Group A Strep
RSV

This Device is CLIA waived for all tests

How is it Billed?

Billing: CPT code(s) 87502QW for Influenza A&B and 87634QW for R

How to get started & Cost

For questions
- Call 224.667.6100
- Or contact customer service
To purchase
- ——-
To get started for training on different tests visit this link

Summary

Tests Performed	COVID-19, influenza A & B, group A streptococcus, and Respiratory Syncytial Virus (RSV).
Type of Machine	Molecular point-of-care (POC) test
CLIA Waived?	Yes
Time to result	5-13 minutes total
Accuracy	Sensitivity ≥ 98.6% Specificity ≥ 98.6%
Price
Key Feature	Point of care antibody test Simple sample prep, intuitive interface, step-by-step guidance for instrument use and workflow, and built-in quality control checks
How to get started	Submit an inquire form For training on antibody testing, visit this link For training on antigen testing, visit this link

BD Veritor Plus System

What is it?

BD Veritor Plus System™by Becton, Dickinson and Company is a portable point-of-care testing device for SARS-CoV-2, Flu A+B, RSV (respiratory syncytial virus), and GAS(Group A Streptococcus). This device is CLIA-waivedand has various ways to record and report results to easily adjust to test volume of the facility in which the device is used.

How does it work?

A sample is collected via nasal swab and in as few as 6 minutes, the result will display on the screen with “+” or “-” sign indicating presence or absence of pathogen.

How do I use it?

Gather materials and label test device with specimen ID
Remove cap from extraction reagent tube
Insert patient sable sway and plunge the swab up and down for 15 seconds
Remove the swab while squeezing the tube to extract liquid.
Press the dispensing tip on the tube firmly. Mix sample.
Analyze now mode or walk away mode can be used
Results will appear on screen

How long will it take to obtain results?

COVID-19 results will appear in 15 minutes
Flu A+B and RSV <11 min
GAS <6 min

Key Features

User friendly and easy to adopt
Staff will be equipped with an e-learning platform which includes training modules, how-to videos, protocols, and dashboards
Results from this machine are 80-90% sensitive and have a specificity of >99%

This machine can perform tests for:

Covid-19
Flu A & B
RSV(Respiratory Syncytial Virus)
GAS(Group A Streptococcus)

This device is CLIA waived for all tests

How is it billed?

CPT codes found here.

How to get started & Cost

For questions
- Call 1.844.8.BD.LIFE (844.823.5433)
- Or contact customer service
To purchase
- Fill out this inquire form
To get started for training on different tests visit this link

Summary

Tests Performed	Covid-19 antigen and antibody
Type of Machine	microfluidic immunofluorescence assay
CLIA Waived?	Yes
Time to result	11 minutes from time test starts running Prep + test time = 12 minutes total
Accuracy	Covid Ab: 100% positive and negative agreement Covid Ag: 97.6% positive and 96.6% negative agreement
Size	2.42 lbs
Price
Key Feature	Point of care antibody test Simple sample prep, intuitive interface, step-by-step guidance for instrument use and workflow, and built-in quality control checks
How to get started	Submit an inquire form For training on antibody testing, visit this link For training on antigen testing, visit this link

LumiraDx

What is it?

The LumiraDx SARS-CoV-2 Ag Test is a microfluidic immunofluorescence assay test manufactured by LumiraDx UK Ltd that can be used to detect Covid-19 in patients who are in the first twelve days of symptom onset, or who may not be symptomatic at all.

The LumiraDx Platform can run a multitude of tests, however, only Covid-19 antigen and antibody tests are approved under EUA in the US to run on this machine.

How does it work?

Uses a combination RBD and S1 spike SARS CoV-2 antigen for detection of total antibodies elicited in response to SARS-CoV-2 infection

Microfluidic immunofluorescence detect nucleocapsid protein antigens

How do I use it?

Prep sample by obtaining a nasal, nasopharyngeal swab, or blood sample and mixing the sample in a provided tube
Insert the test strip and select the test you want to run on the machine
Apply the sample to the test strip and run the test

How long will it take to obtain results?

11 minutes from when the test starts running
12 minutes total – 1 minute of sample prep and application, 11 minutes of run time

Key Features

Simple sample prep, intuitive interface, step-by-step guidance for instrument use and workflow, and built-in quality control checks
Machine itself weighs 2.42 lbs, uses rechargeable batteries, and is portable
Uses cloud-based services so users can remotely manage results from a tablet, mobile device, or PC
Covid ab test clinical performance of 100% positive and negative percent agreement compared to laboratory PCR tests
Covid ag test clinical performance of 97.6% positive agreement and 96.6% negative agreement compared to laboratory PCR tests
Gained EUA for Covid-19 antigen testing in August 2020
Can save up to 1000 patient test results with time, date, and comments
Compatible with printer for printed results

This machine can perform tests for:

Covid-19 antigen and antibody

This machine is CLIA waived for all tests

How is it billed?

Use CPT code 87426 for antigen testing

How to get started & Cost

For questions
- Contact customerservices.us@lumiradx.com
- Call 1-888-586-4721
To purchase
- Fill out this inquire form
To get started
- For training on antibody testing, visit this link

Summary

Tests Performed	Covid-19 antigen and antibody
Type of Machine	microfluidic immunofluorescence assay
CLIA Waived?	Yes
Time to result	11 minutes from time test starts running Prep + test time = 12 minutes total
Accuracy	Covid Ab: 100% positive and negative agreement Covid Ag: 97.6% positive and 96.6% negative agreement
Size	2.42 lbs
Price
Key Feature	Point of care antibody test Simple sample prep, intuitive interface, step-by-step guidance for instrument use and workflow, and built-in quality control checks
How to get started	Submit an inquire form For training on antibody testing, visit this link For training on antigen testing, visit this link

GeneXpert Xpress

What is it?

The GeneXpert Xpress is a CLIA waived, point of care PCR testing machine manufactured by Cepheid to test for respiratory infectious diseases such as Covid-19, RSV, Flu, and strep A. This machine offers combined tests and has the capability to test for Covid-19, flu, and RSV or flu and RSV with one patient sample.

Additionally, this single machine can run up to four patient tests at one time. Running tests on this machine are simple as there are few steps and the software and technology is intuitive and easy to use.

How does it work?

How do I use it

Obtain a swab specimen
Transfer the sample to a cartridge
Insert cartridge and start test

How long does it take to obtain results?

CoV-2/Flu/RSV plus – as little as 25 minutes*
CoV-2 plus – as little as 20 minutes*
Flu/RSV – as little as 20 minutes*
Flu – as little as 20 minutes*
Strep A – as little as 18 minutes*

* Once the test starts running, however prep time is not extensive

Key Features

Single, compact, benchtop instrument that can run up to four tests at one time
Intuitive, easy-to-use technology and software reduces training and time to use
Automated sample extraction, PCR amplification, detection, and result display
Integrated quality control in every test cartridge
Bi-directional interface with laboratory information system and point-of-care data managers
System monitoring, reporting, and IT troubleshooting with Cepheid C360 software
Built-in barcode scanner and full-size touchscreen
mix-and-match test capabilities
Remote printing capabilities
No daily maintenance required
Wired and wireless network connection capabilities
Womens and sexual health testing to be CLIA waived soon
Sensitivity: 99%
Specificity: 97%

This machine can perform tests for:

CoV-2/Flu/RSV plus
CoV-2 plus
Flu/RSV
Flu
Strep A

This machine is CLIA waived for all tests

How is it billed?

For CPT codes and reimbursement rates, see here

How to get started & Cost

Questions for Cepheid
- Contact support here
- Submit an online support request here
- Request info here
To order a machine
- Submit an order request form here
- Pricing:
To set up a new machine
- For product information, visit here
- For technical documentation and videos, visit here
- For self-service and training videos, visit here

Summary

Tests Performed	Covid-19, Flu A&B, RSV, strep
Type of Machine	PCR
CLIA Waived?	Yes
Time to result	CoV-2/Flu/RSV plus – as little as 25 minutes CoV-2 plus – as little as 20 minutes Flu/RSV – as little as 20 minutes Flu – as little as 20 minutes Strep A – as little as 18 minutes
Sensitivity Specificity	Sensitivity: 99% Specificity: 97%
Size	11. 5” W x 18” H* x 16” D*
Price
Key Feature	Can run multiple tests at once Can run multiple tests with 1 sample
How to get started	Submit an order request form here Visit here for produce information and here for training

Quidel Sofia 2 Flourescent Immunoassay Analyzer

What is it?

The Quidel Sofia 2 is a benchtop analyzer manufactured by the Quidel Corporation that uses fluorescence detection to analyze data points in patient samples to look for markers to diagnose gastrointestinal, respiratory, vector-borne illness, and more in as little as 3 minutes. This test can also run multiple tests at once with one patient sample. This machine is CLIA waived for all tests that require a nasal or nasopharyngeal swab.

How does it work?

Samples are exposed to reagents that disrupt viral particles and expose viral nucleoproteins
Samples migrate through a test strip containing unique chemical environments and fluorescent signals are measured

How do I use it?

Prep test tube by adding appropriate reagent solution and swirling solution in tube

Obtain a sample with provided collection tool (nasal/nasopharyngeal swab, fecal sample, urine sample)

Place sample swab into the test tube with the reagent, roll the swab at least 3 times while pressing the head of the swab to the bottom of the tube, and leave the swab in the tube for at least 1 minute

1. Remove the swab from the tube by rolling the swab head along the walls of the tube at least 3 times

Using the provided pipette, aliquot solution from the reagent tube and dispense it onto the well of a testing cassette

Log into the Sofia 2 machine and enter the patient ID via touchscreen or barcode scan
Ensure the machine is set to the preferred mode
1. If using “walk away” mode, follow video prompt and insert cassette into the machine immediately
2. If using “read now” mode, let the sample develop in the cassette on a benchtop outside of the machine for 15 manually timed minutes before inserting into the machine
Depending on what mode is selected and the result of the test, results will show up at varying times on the digital screen, save automatically to the onboard data management system, and can be printed to external attached printers

*Note that this machine requires extensive sample preparation

How long will it take to obtain results?

This machine can read results in two modes depending on workflow needs.

“Walk away” mode – Flu A&B, RSV, Lyme, and hCG can turn up positive after 3 minutes
- May take longer to return a positive result
“Read now” mode – 15 minutes

All Covid-19 results need to be reported according to state and national standards. More information can be found here.

This machine can perform tests for:

COVID-19 rapid antigen (SARS)
Influenza A & B
Respiratory Syncytial Virus (RSV)
Group A Streptococcus
Human chorionic gonadotropin (hCG)
Lyme disease
Campylobacter

Test	Sample Type	CLIA Status	Time to Results
Sars	Nasal, Nasopharyngeal swab	Waived	15 minutes
Flu A+B	Nasal, Nasopharyngeal swab	Waived	15 minutes
RSV	Nasal, Nasopharyngeal swab, aspirate	Waived	3-15 minutes
Strep	Throat swab	Waived	5 minutes
Lyme Disease	Fingerstick whole blood	Waived	3-15 minutes
Flu + SARS	Nasal, Nasopharyngeal swab	Waived	15 minutes
hCG	Urine Sample	Moderate Complexity	3 minutes
Campylobacter	Fecal Sample	Moderate Complexity	15 minutes

Key Features

It is a compact, 2 lb machine with an easy-to-use, intuitive platform with digital videos to prompt steps
Boasts accurate, objective, and automated results with sensitivities > 90% and specificities > 94%
One of the fastest point-of-care testing devices returning some results in as little as 3 minutes
Has the capabilities to be flexible to accommodate workflow demand
Is time and cost efficient as it can run multiple tests with 1 patient sample, as seen with the Flu + SARS test
Covid testing on this device originally gained EUA in December of 2020
Can store up to 1000 patient results and can print or export data

How to Get Started & Cost

Questions for Quidel
- To evaluate a kit or questions about product information, visit this link
- For a demo video, visit here
To order a machine
- You can submit an order request form directly on the Quidel website
- You can order a machine and tests through some pharmacy and medical device wholesalers such as McKesson or Fisher Scientific
  - Quidel Sofia 2 Analyzer through Fisher Scientific: $2,080.00
  - Varying costs for different tests/assays
    - 2 FLU + SARS test – Pack of 25: $710.21, Case of 12 Pack: $8,529.86
    - SARS test Nasal/Nasopharyngeal Swab- Pack of 25: $658.50, Case of 12 Pack: $7,910.00
    - Lyme test – Pack of 25: $911.56, Case of 12 Pack: $10,940.80
    - Couldn’t find pricing for other tests
To set up a new machine
- Visit this link for step-by-step instructions on how to set up and calibrate the machine, run quality control tests, run patient specimens, watch videos, and obtain training certificates
- All machines come with a user manual, QuickStart Guide, and a Training Tools manual

See here for a video demonstration on how to use the machine

How is it Billed?

For CPT codes and reimbursement rates, visit here

Summary

Tests Performed	Covid-19, Flu A&B, RSV, strep, Lyme, hCG, campylobacter
Type of Machine	Fluorescent immunoassay analyzer
CLIA Waived?	Yes for all except hCG, campylobacter
Time to result	3-15 minutes
Sensitivity Specificity	> 90%, varies by test > 94%, varies by test
Size	2 lbs, 22 cm deep x 12 cm wide x 12 cm high
Price	$2,080.00 + varying costs of tests
Key Feature	Can run multiple tests with 1 sample 2 performance modes to meet workflow needs
How to get started	Submit an order request form Visit this link for step-by-step instructions

Siemens Clinitek Status + Urine Analyzer

What is it?

CLINITEK Status®+ Analyzer from Siemens Medical Solutions USA, Inc. is a point-of-care urinalysis analyzer for urinalysis testing and urine hCG pregnancy testing.

It is CLIA-waived for both of these tests, is efficient, eliminates error sources and improves data integrity.

How does it work?

To provide clinical information, the system automatically checks each test strip for humidity exposure, common sample interferences and identifies Siemens test strips.

How do I use it?

Patient urine sample is appropriately collected
Reagent strip is placed in a urine sample
The urine sample is then placed in the analyzer

How long will it take to obtain results?

Urinalysis	In as little as 1 minute
hCG	In as little as 5 minutes

Key Features

This device can store up to 700 patient test results and allows for printing and exporting.
Outputs from a result include: Operator ID, patient name, patient ID, color/clarity of urine, test strip lot #, expiration date, time/date of test, result itself (Glucose, Bilirubin, Ketones, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes)
Increases workflow efficiency due to its true walkaway convenience and limited wait times.
Eliminates error sources and accurately times the test for you.
Improved data integrity, removes subjectivity of result interpretation and minimizes transcription errors.

How to get started & Cost

For questions:
- Customer service is available here and at 1-800-888-7436 (SIEM).
To order a machine
- You can order a machine and tests through some pharmacy and medical device wholesalers such as McKesson or Fisher Scientific
  - Quidel Sofia 2 Analyzer through Fisher Scientific: $1,703.00
  - Varying costs for different tests/assays starting at $217+
- For additional information, you may also contact Siemens Healthineers to find out more about the CLINITEK Status® Analyzers by calling , 877-229-3711 prompt 13 & 2.
To set up a new machine
- Visit this link for step-by-step instructions on how to set up and calibrate the machine, run quality control tests, run patient specimens, watch videos, and obtain training certificates
Resources such as user manual, installation video, product training and support tools can be found here.

How is it Billed?

Billing: CPT code(s) 81003QW, 82044QW, 82570QW, 84703QW for urinalysis and 84703QW for hCG

Summary

Tests Performed	Urinalysis and Human chorionic gonadotropin (HCG)
Type of Machine	Automated point-of-care urinalysis analyzer
CLIA Waived?	Yes for both tests.
Time to result	1-5 minutes
Size	3.65 lbs, 10.70 in. deep, 6.70 in. wide x 6.20 in. high
Price	$1,703.00 + varying costs of tests
Key Feature	Can run multiple tests with 1 sample 2 performance modes to meet workflow needs
How to get started	Purchases can be done through various distributors found here.

Cobas Liat System

What is it?

This small and compact design made by Roche Diagnostics Corporation can fit into any setting such as clinics, urgent care or satellite location. As of 2020, this system is CLIA-waived for SARS-CoV-2 & Influenza A/B Nucleic Acid Test. However, it can be used for PCR

This machine can perform tests for:

COVID-19 antigen
Influenza A&B*
Respiratory Syncytial Virus (RSV)
Group A Streptococcus*
C-diff

This machine is CLIA waived for SARS-CoV-2 & Influenza A/B Nucleic Acid Test

This machine can perform tests for:

COVID-19 antigen
Influenza A&B*
Respiratory Syncytial Virus (RSV)
Group A Streptococcus*
C-diff

This machine is CLIA waived for SARS-CoV-2 & Influenza A/B Nucleic Acid Test

How does it work?

Each cobas Liat assay tube contains a set of chemical reagents used in the detection of DNA or RNA sequences unique to a particular infectious disease.

How to use it?

Patient sample is obtained and added to the appropriate assay tube with the provided transfer pipette
Place the assay tube under the built-in barcode scanner and then insert the assay into the device
The device will utilize Polymerase Chain Reaction (PCR) technology to analyze the obtained sample

How long will it take to obtain results?

Group A Strep	In as little as 15 minutes
C-diff, COVID-19 antigen, Influenza A&B, RSV	In as little as 20 minutes

Key Features

Small, compact design to fit any setting such as clinic, urgent care or satellite location.
This analyzer can store up to 20,000 patient test results.
Included features to print and export results that include assay name, sample ID, and date/time of test.
Convenience of fully automated system with an intuitive user interface with results that are easy to interpret.

How to get started & Cost

For questions:
- Submit support requests online with Case Management service in Roche Dialog here.
- Customer service is available here and at 1-800-428-5076.
To order a machine
- Roche Diagnostics operates in over 100 countries worldwide. Visit this link to find a list of local offices that can help you with your sales inquiries.
To set up a new machine
- Here is an educational video showing a step-by-step instructions for the Cobas® Liat® System
- Operators manual can be found here.

Specific Remarks:

All COVID-19 results, whether positive or negative, need to be reported according to state and national standards. More information can be found here.

How is it billed?

Billing: CPT code(s) 87502QW for Influenza A&B, 87631QW for RSV, and 87651QW for Group A Streptococcus

Summary

Tests Performed	PCR COVID-19 antigen, influenza A&B, Respiratory Syncytial Virus (RSV), Group A Streptococcus and Clostridioides difficile.
CLIA Waived?	Yes, for SARS-CoV-2 & Influenza A/B Nucleic Acid Test
Time to result	15 minutes for Group A Strep. 20 minutes for C-diff, COVID-19 antigen, Influenza A&B, RSV.
Accuracy	COVID-19 Sensitivity = 100% Specificity = 97.4% Influenza A&B Sensitivity = 97.9% Specificity = 97.5%
Price	For inquiries, submit an order request form.
Key Feature	Small, compact design, can store up to 20,000 patient test results.
How to get started	Training and videos are available.

OraSure Technologies

What is it?

OraSure Technologies offers three versions of rapid infectious disease tests for point-of-care diagnostics with minimal steps. The InteliSwabis used for Covid-19 testing, the ORAQUICK is used for HCV testing, and the ORAQUICK ADVANCE is used for HIV testing.

These tests do not require any external laboratory equipment, instruments, batteries, compatible technology, smart devices, or laboratory analysis. All three tests are CLIA waived.

This machine can perform tests for:

Covid-19 antigen
Hepatitis C antibodies (HCV)
HIV-1 & HIV-2 antibodies

This machine is CLIA waived for all tests

How does it work?

InteliSwab lateral flow tests detect Covid-19 antigens
ORAQUICK and ORAQUICK ADVANCE test for HCV and HIV antibodies

How do I use it?

InteliSwab

Insert flat pad of the swab into the nostril and circle around the nostril 15 times. Repeat in other nostril
Insert swab into the test tube on the test stand. Swirl the swab 10 times
Leave the swab in the test tube stand with the result window facing forward and the swab pad touching the bottom of the tube

ORAQUICK and ORAQUICK ADVANCE

Collect sample of patients blood via either fingerstick or venipuncture
Use provided collection loop to obtain a sample drop of blood
Mix sample of patient blood by swirling the loop in the test tube with developing solution
Unpackage the flat pad swab device and insert it, flat pad side down, in the test tube full of sample and solution

How long does it take to obtain results?

ORAQUICK HCV and ORAQUICK ADVANCE HIV	20 minutes
InteliSwab Covid-19	30 minutes

Key Features

Do not require extensive preparation, equipment, technology, or batteries
- However this means no internal memory system for storing or reporting patient results
The ORAQUICK and ORAQUICK ADVANCE results are > 98% accurate
InteliSwab is 98% accurate for negative samples and 85% accurate for positive samples
InteliSwab is indicated for people 2 years and older who are within 7 days of symptom onset, or those without symptoms who are tested twice over the course of 2-3 days
InteliSwab is the selected rapid covid test by the federal government for nationwide school testing
Inteliswab can detect the covid-19 omicron variant and all omicron sub-variants

How to get started & Costs

For questions
- To inquire about tests, visit here
To purchase tests
- Fill out this interest form to inquire about bulk purchasing InteliSwab
- Fill out this form to inquire about ORAQUICK and the ORAQUICK ADVANCE
- Contact your pharmacy or medical device wholesaler such as Fisher Scientific
  - Pack of 25 ORAQUICK tests: $535.00
  - Pack of 25 ORAQUICK ADVANCE tests: $782.00
  - Pack of 25 InteliSwag tests: $503.00
For training and getting started
- Each test has an online training guide videos and documents ORAQUICK, ORAQUICK ADVANCE, IteliSwab

Billing:

CPT code for ORAQUICK ADVANCE: G0433QW
CPT codes for ORAQUICK: 86803QW, G0472QW
CPT code for InteliSwab: 87426

Summary

Tests Performed	Covid-19, HCV, HIV
CLIA Waived?	Yes
Time to result	20 minutes for HIV, HCV 30 minutes for Covid-19
Accuracy	98% for HIV, HCV tests > 85% for Covid-19 tests
Price	Pack of 25 ORAQUICK tests: $535.00 Pack of 25 ORAQUICK ADVANCE tests: $782.00 Pack of 25 InteliSwag tests: $503.00
Key Feature	No batteries or technology needed Federal government’s choice of rapid covid-19 test
How to get started	Submit an order request form Visit ORAQUICK, ORAQUICK ADVANCE, IteliSwab for trainings

CoronaCheck - rapid antigen test

What is it?

The Rapid Antigen Test by 20/20 Genesystems, Inc. is a serology test that detects antibodies against SARS-CoV-2 in a blood sample taken from the test subject.

CoronaCheck has various tests available such as rapid antigen, molecular and lab-based. As of October 2020, the three tests by CoronaCheck have FDA EUA Authorization.

This machine can perform tests for:

COVID-19 Rapid Antigen
COVID-19 molecular test
Lab-based COVID-19 antibody test

How does it work?

The Antigen test is a lateral flow immunochromatographic assay

Used for the qualitative recognition of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens.

How to use it:

Obtain sample from patient by inserting swab into the posterior nasopharynx
Place the sample into the extraction vial and rotate the swab at least 5 times
Remove the swab and close the vial with a cap
Mix thoroughly by flicking the bottom of the tube
Invert the extraction vial and squeeze the vial gently to release 3 drops of the sample onto the sample well
Wait 10 minutes and read result

How long will it take to obtain results?

Rapid Antigen

In as little as 10 minutes

(+) One red-colored line next to “C” and one blue-colored line next to “T”

(-) One red-colored line only next to “C”

Key Features

Results in 10 minutes
Highly accurate and easy to use
Equipment is not required

Documentation (COVID-19 Rapid Antigen):

Collect Patient Information before administering
One-time use Point-of-care test
- Results are analyzed visually
Can print results or export data
All COVID-19 results, whether positiveor negative, need to be reported according to state and national standards. More information can be found here

How to get started & Cost

Questions
- An inquiry form is available here.
To order a machine
- Visit CoronaCheck to order.
- For larger quantities, contact sales@coronachecktest.com or call at (240) 453-6339

Billing:

HCPCS U0001 for RT-PCR and U0002 for any other technique

Summary:

Tests Performed	COVID-19 Rapid Antigen, COVID-19 molecular test andLab-based COVID-19 antibody test
Type of Machine	Serology test
CLIA Waived?	They all are FDA EUA Authorization.
Time to result	10 minutes.
Price	$500.00 per box for 1-10 boxes $475.00 per box for 11-25 boxes
Key Feature	Results appear on a test strip in 10 minutes. Bulk Discounts Available.
How to get started	Visit CoronaCheck to order.

CardioCheck Plus

What is it?

The CardioChek Plus is a portable analyzer manufactured by PTS Diagnostics to provide rapid, on-site blood chemistry values. This machine can test lipid profiles, blood glucose, and/or both simultaneously with a single fingerstick sample of a patient’s blood.

It uses the same technology as clinical laboratories but returns results in 90 seconds. This machine is CLIA waived, meets NCEP guidelines for accuracy, is CRMLN-certified for cholesterol testing, and is FDA approved.

This machine measures:

Total Cholesterol
HDL cholesterol
Triglycerides
Glucose

This machine is CLIA waived

this machine calculates:

LDL cholesterol
TC/HDL ratio
LDL/HDL ratio
non-HDL cholesterol

How does it work?

Uses light reflectance and electrochemical biosensor technology to measure enzymatic chemical reactions
- Lipid Tests – Reflectance test strips change color via chemical reaction when blood is applied
- Glucose Tests – Electrochemical test strips produce an electric current when blood is applied
  - Change in color and current are measured and compared to a calibration curve stored in the MEMo chip
  - Analyzer converts the colors and currents into test results

How do I use it?

Reflectance Test – for lipid testing

Turn on the analyzer, insert MEMo chip, and insert strip into designated reflectance test strip slot
Obtain a patient sample of blood and drop it onto the test strip via capillary tube
Results will appear in 90 seconds

Electrochemical Test – for blood glucose

Turn on the analyzer, insert MEMo chip, and insert strip into designated electrochemical test strip slot
Obtain a sample of patient blood, preferably via lancet fingerstick. Hold the patient’s finger up to the tip of the test strip to get the blood directly on the test strip

How long does it take to obtain results?

90 Seconds

Key Features

Compact, lightweight, portable, and battery-operated
Offers wireless communication for easy data transfer and printing
Claims to be one of the fastest, most cost-efficient, user-friendly analyzers
Device stores up to 50 patient results for each chemistry including test name, results, time of sample
Digital screen for ease of use and reading results
Lab-quality accuracy
Only required 40 microliters of blood

How to get started & Cost

For questions
- General questions and product inquiries, visit here
To order devices
- Visit this link for a map and list of regional, national, and online PTS diagnostic distributors
- Email orders@ptsdiagnostics.com to inquire about ordering and/or distributors
- Per Fisher Scientific: Analyzer – $1279.00

Printer – $313.00

50 pack of electrochemical test strips & MEMo chip – $87.90

Lipid Promo Pack – $931.39

To get started with your device
- Professional product training is available on PTS diagnostics website and is complete with videos, quizzes, and certificates
- Request a custom hosted webinar here
- Find user guides here

Billing:

For more information on CPT codes and reimbursement, please visit here.

Summary:

Tests Performed	Lipid panel (TC, HDL,TG), blood glucose Calculates: LDL, non-HDL, LDL/HDL, TC/HDL
CLIA Waived?	Yes
Time to result	90 seconds
Price	Analyzer – $1279.00 + cost of strips
Key Feature	Fast, portable, lab quality results Minimal steps/equipment to use
How to get started	Visit this link or email orders@ptsdiagnostics.com Follow the user guide or website for additional trainings

Results:

Cholesterol

Sensitivity = 76%

Specificity = 93%

HDL Cholesterol

Sensitivity = 87%

Specificity = 93%

Triglycerides

Sensitivity = 98%

Specificity = 99%

Afinion 2

What is it?

Afinion, manufactured by Abbott Point of Care Diagnostics, is a compact, rapid, multi-assay machine that can reliably provide valuable near patient testing at the point-of-care. It can quantitatively determine HbA1c, Lipid Panel, ACR, and CRP.

This machine can perform tests for:

HbA1c
Lipid Panel
ACR
CRP

This machine is CLIA waived for all tests

How does it work?

This analyzer automatically transfers patient and control results via TCP/IP networking using the protocols POCT1-A, HL7, ASTM 1381-85 (low level) or ASTM 1394-97 (high level).

How do I use it?

Remove capillary device from the foil pouch and obtain patient’s blood sample
Insert capillary device with blood sample into the appropriate cartridge
Put cartridge into the device for analysis

How long will it take to obtain results?

A1C	In as little as 3 minutes	%
ACR	In as little as 5 minutes	mg/g

Key Features

Fixed calibration that is used for calculating accurate results.
Multiple sample types available.
All-in-one test cartridge for sample collection in one single test.
QC an operator lockout
USB connection for optional barcode reader and printer

How to get started & Cost

Fixed calibration that is used for calculating accurate res
- For questions:
  - Customer service is available here and at 1- 877-441-7440.
- To order a machine
  - Visit this link to submit a form for sales inquiries.
- To set up a new machine
  - Here is a product demo.
A video on how to get started can be found here.ults.
Multiple sample types available.
All-in-one test cartridge for sample collection in one single test.
QC an operator lockout
USB connection for optional barcode reader and printer

Fixed calibration that is used for calculating accurate res
- For questions:
  - Customer service is available here and at 1- 877-441-7440.
- To order a machine
  - Visit this link to submit a form for sales inquiries.
- To set up a new machine
  - Here is a product demo.
A video on how to get started can be found here.ults.
Multiple sample types available.
All-in-one test cartridge for sample collection in one single test.
QC an operator lockout
USB connection for optional barcode reader and printer

Billing:

CPT code(s) 83036QW for A1C

Summary

Tests Performed	HbA1c, Lipid Panel, ACR, and CRP.
Type of Machine	Multi-assay analyzer
CLIA Waived?	Yes, for all
Time to result	3-5 minutes
Size	7.5 lbs, 7.2 x 7.5 x 13.0 (in)
Price	$4,127.35 + varying costs of tests
Key Feature	Can run multiple tests with 1 sample No calibration or maintenance needed
How to get started	Visit this link to submit a form for sales inquiries. A video on how to get started can be found here.

Curo L5

What is it?

Curo L5 is manufactured by Osang Healthcare Co and is a fast, portable and reliable device that can provide results for total cholesterol, triglycerides and glucose. These tests are all CLIA waived and results are available in 2-3 minutes.

What tests can this machine perform?

Total Cholesterol
Triglycerides
Glucose

This machine is CLIA waived for all tests

How does it work?

Lipid panel utilizes spectroscopy while the glucose reading uses an electrochemical test

How to use it:

Insert test strip at the bottom of the device and enter the power button
Prick finger with lancet and use capillary rod to obtain a blood sample
Place the lancet on the test strip at a 45 degree angle and wait until you hear a beep
Wait 3 seconds to 2 minutes for results

How long will it take to obtain results?

Total Cholesterol and Triglycerides

In as little as 2 minutes

Glucose

In as little as 3 seconds

Testing ranges:

Cholesterol (100-450mg/dL)

Triglycerides (70-600 mg/dL)

Glucose (20-600 mg/dL)

Key Features

Small enough to be held with one hand and easily fits in the pouch or bag
Requires AAA batteries
1 year warranty included
200 tests results stored on device

How to get started & Cost

For questions:
- Customer service is available at 1-888-930-0030.
To order a machine
- Visit this link to purchase with free shipping on all orders over $50.00
To set up a new machine
- Here is an introduction video.
- A video on how to get started can be found here.

Billing

CPT code(s) 80061QW, 82465QW, 82962QW, 83718QW, 84478QW for lipid panel and glucose

Summary

Tests Performed	Total cholesterol, triglycerides and glucose
Type of Machine	Blood Cholesterol Testing Device
CLIA Waived?	Yes for all
Time to result	3 secs – 2 minutes
Size	282 grams, 4 x 2.5 x 1 inches
Price	$79.00 + varying costs of tests
Key Feature	Small to fit in one hand Results within seconds
How to get started	A video on how to get started can be found here.

AimStrip Tandem

What is it?

The AimStrip Tandem is a system manufactured by Germaine Laboratories to measure total cholesterol, triglycerides, and glucose from a small sample of capillary whole blood. It is a small, rapid, point of care testing device that is CLIA waived, requires zero maintenance, and minimal training.

This machine can perform tests for:

Total Cholesterol
Triglycerides
Glucose

this machine is CLIA waived for all tests

How does it work?

Lipid profile test – utilizes spectroscopy to detect enzymatic-colorimetric activity
Glucose test – utilizes electrochemical technology

How do I use it?

Spectroscopy Test – for lipid profile testing

Turn on the analyzer and insert strip into designated test strip slot
1. Red test strips are for cholesterol tests
2. Green test strips are for triglyceride tests
Obtain 5 microliters of a patient sample of blood via fingerstick and drop it onto the test strip via capillary tube
Results will appear in 2 minutes

Electrochemical Test – for blood glucose testing

Turn on the analyzer and insert strip into designated electrochemical test strip slot
Obtain a 0.3 microliter sample of patient blood via lanced fingerstick. Hold the patient’s finger up to the tip of the test strip to get the blood directly on the test strip
Results will appear in 3 seconds

How long will it take to obtain results?

Total Cholesterol and Triglycerides

In as little as 2 minutes

Glucose

In as little as 3 seconds

Testing ranges:

Cholesterol (100-400mg/dL)

Triglycerides (70-600 mg/dL)

Glucose (20-600 mg/dL)

Key Features

Small, portable, handheld, 77 gram machine for point of care testing
Rapid results in 3-120 seconds
Minimal training time, no maintenance, and battery operated
Battery powered with lifetime of 1,000 tests
Capable to be connected to PC, printer, or meter

Billing

CPT code(s) 82465QW for cholesterol and 84478QW for Triglycerides

How to get starts & Cost

For questions
- You can fill out this form
- You can also email sales@germainlabs.com or call 800-854-8446
To order a machine
- You can fill out this form
- You can also email sales@germainlabs.com
  - Cost per Fisher Scientific
    - Machine: $258.50
    - Pack of 50 blood glucose test strips: $23.50
    - Pack of 10 cholesterol test strips: $78.00
    - Pack of 10 triglyceride test strips: $78.80

Summary

Tests Performed	Lipid panel (Cholesterol, TG), blood glucose
CLIA Waived?	Yes
Time to result	3 seconds – glucose 2 minutes – lipid profile
Price	Machine: $258.50 Pack of 50 blood glucose test strips: $23.50 Pack of 10 cholesterol test strips: $78.00 Pack of 10 triglyceride test strips: $78.80
Key Feature	Fast, portable Minimal steps/equipment to use
How to get started	fill out this form email sales@germainlabs.com

A1CNOW+

What is it?

The A1CNow®+ is a point of care system manufactured by PTS Diagnostics that provides accurate HbA1C results in 5 minutes with a mere fingerstick. This system is small, portable, easy to use, and CLIA waived.

This machine can perform tests for:

HbA1C

This machine is CLIA waived

How does it work?

With patented technology, 1 test strip runs two tests to give the patient’s HbA1c
- Test 1 – measures glucose-modified red blood cells via light reflectance technology
- Test 2 – measures total red blood cells

How do I use it?

Obtain small blood sample and use provided blood collector capillary device to draw up the necessary volume of blood
Insert blood collector device into the “shaker” body and mix vigorously 6-8 times
Open foil cartridge pack and insert cartridge into the analyzer device
Remove shaker base and when analyzer displays “SMPL”, dispense sample into cartridge by pushing down completely on shaker body and then removing quickly
Wait 5 minutes for result

How long will it take to obtain results?

5 minutes

Key Features

Faster, easier, and more efficient than sending bloodwork to the lab for HbA1C results

Small and portable
Minimal training required
Uses only 5 microliters of blood (as opposed to venipuncture)
No maintenance required
99% accuracy as compared to lab run tests with venous blood
HbA1C results in 5 minutes at point of care

Compatible to send data to third-party data management system and/or printer

Billing

Visit this link for more information about CPT codes and reimbursement rates.

How to get started & Costs

For questions
- General questions and product inquiries, visit here
To order you can
- Visit this link for a map and list of regional, national, and online PTS diagnostic distributors
- Email orders@ptsdiagnostics.com to inquire about ordering and/or distributors
- Submit this PTS diagnostics contact us form
  - Pricing according to Fisher Scientific
    - 20-count-test kit
      - Pack of 20: $238.50
      - Case of 24 Pack: $5,580.00
To get started
- Professional product training is available on PTS diagnostics website and is complete with videos, quizzes, and certificates
- Request a custom hosted webinar here
- Find user guides here

Summary

Tests Performed	HbA1C
CLIA Waived?	Yes
Time to result	5 minutes
Price
Accuracy	99%
Key Feature	Fast, portable, lab quality results at point of care Minimal steps/equipment to use
How to get started	Visit this link or email orders@ptsdiagnostics.com Follow the user guide or website for additional trainings

Coag-Sense P2 Meter

What is it?

The Coag-Sense PT2 meter is a device manufactured by CoaguSense Inc. to measure PT and INR for patients on oral Coumadin at point-of-care. This meter provides gold-standard, accurate results in less than a minute with a fingerstick sample of blood. Additionally, this device is the only CLIA waived system to produce prothrombin time. Also, the monitor requires minimal training and steps to use, providing a more accessible, direct approach to INR monitoring.

This machine can perform tests for:

INR
Prothrombin Time (PT)

This machine is CLIA waived for all tests

How does it work?

Micro-mechanical technology measures actual clotting time for a real PT measurement

How do I use it?

Insert test strip into meter
Obtain 10-12 microliter sample of blood by lancing finger and collect blood with provided capillary tube
Dispense sample onto test strip
Wait for results

How long will it take to obtain results?

< 1 minute

Key Features

Ability to run whole blood, plasma controls, and plasma calibrants
only CLIA-Waived system that returns a true prothrombin time
The only point-of-care testing system that directly detects clotting endpoint by emulating the WHO Tilt-Tube method
Offers proven, gold standard accuracy and precision
INR range from 0.8 to 8.0
Simple and accurate sample collection and transfer

Conveniently portable, chargeable, packable, connected design
Sends results to service provider using app
Siemens software compatible
Can be connected to a printer, computer, scanner, etc

Billing

Use CPT code 85610QW

How to get started & Cost

For questions
- Contact CoaguSense Inc. by filling out this form
- Email support@coagusense.com or call 1-866-903-0890
To order a machine
- Fill out this form to contact sales
- Pricing per Fisher Scientific
  - Machine: $703.00
  - Pack of 50 test strip kit: $196.90
  - Portable printer: $267.65
  - Capillary transfer tubes pack of 54: $18.18
  - Pack of 100 lancets: $11.00
To get started on your machine you can
- Visit this link for a quick reference guide
- Visit this link for a professional user manual
- Visit this link for training videos
- Call technical support at 1-866-903-0890

Summary

Tests Performed	Prothrombin Time, INR
CLIA Waived?	Yes
Time to result	1 minute
Accuracy	View here
Price	Machine: $703.00 Pack of 50 test strip kit: $196.90 Costs of other supplies
Key Feature	Only point-of-care testing system that directly detects clotting endpoint Only CLIA-Waived system that returns a true prothrombin time
How to get started	Fill out this form to contact sales Review the quick reference guide, professional user manual, and videos

Cholestech LDX

What is it?

The Cholestech LDX Analyzer is a point of care testing device manufactured by Abbott Laboratories used to rapidly test lipid profiles, cholesterol, and glucose. This CLIA waived machine provides rapid results in 5 minutes, while meeting NCEP, LSP, and CRMLN performance-goal standards for accuracy.

this machine can perform tests for:

Total Cholesterol
HDL cholesterol
Triglycerides
Glucose

This machine is CLIA waived for all tests

This machine calculates

LDL cholesterol
TC/HDL ratio
LDL/HDL ratio
non-HDL cholesterol

How does it work?

Glucose test – uses glucose oxidase enzyme that oxidizes glucose to gluconolactone and hydrogen peroxide. A second reaction produces a detectable color that is picked up by the photometer inside the Cholestech LDX analyzer
Lipid profile test – Red blood cells are separated out and plasma is tested for specific biochemical reactions according to color change

How do I use it?

Perform a fingerstick and collect 40 microliter of bloods within 10 seconds
Dispense the sample into the testing cassette
Insert the cassette and press the RUN button

How long will it take to obtain results?

5 minutes

Key Features

#1 choice used by healthcare professionals in thousands of settings nationwide
Small, fingerstick sample size is less painful and time consuming, and easy to obtain
Automated checks on the system ensure accurate results and eliminate user error
Simple three-step testing
Small, lightweight, portable design
Compatible with external printer

Billing

Please see this link for reimbursement rates and CPT codes

How to get started & Cost

For general questions
- Submit a form to contact Abbott about product inquiry
- For technical support visit this link
To purchase a machine
- Fill out this form to contact sales
- Pricing per Fisher Scientific
  - Analyzer: $3,800.00
  - Total cholesterol pack of 10 test cassettes: $106.10
  - Total cholesterol/glucose pack of 10 test cassettes: $106.10
  - Total cholesterol/HDL pack of 10 test cassettes: $204.00
  - Total cholesterol/HDL/glucose pack of 10 test cassettes: $215.50
  - Lipid profile pack of 10 test cassettes: $244.50
  - Pack of 50 capillary plungers: $11.11
  - Printer: $756.50
To get started with your machine you can
- Find a plethora of helpful documents on the website
- Watch demo videos and modules

For product training, visit this link

Summary

Tests Performed	Lipid profile, glucose
CLIA Waived?	Yes
Time to result	5 minutes
Accuracy	Meets NCEP, LSP, and CRMLN performance-goal standards for accuracy
Price	Analyzer: $3,800.00 Total cholesterol pack of 10 test cassettes: $106.10 Total cholesterol/glucose pack of 10 test cassettes: $106.10 Total cholesterol/HDL pack of 10 test cassettes: $204.00 Total cholesterol/HDL/glucose pack of 10 test cassettes: $215.50 Lipid profile pack of 10 test cassettes: $244.50
Key Feature	#1 choice used by healthcare professionals in thousands of settings nationwide Small, portable, fast, and accurate
How to get started	Fill out this form to contact sales Watch demo videos and read helpful documents

HIGI Machine

What is it?

Higi is a consumer health engagement company by Babylon health, it provides physical access through a network of digital Smart Health Stations. Complementary web and mobile tools enable a consumer’s health engagement, making it simple to understand and take action on their healthcare needs. The data it can give includes weight, blood pressure, pulse, and body mass index (BMI).

This machine can perform tests for:

Weight
Blood pressure
Pulse
BMI

This machine is not CLIA waived

How does it work

Measurements are taken from the upper arm and data is collected and sent to a mobile app. It is intended for use as a public facility.

How to use it:

Sit down at the higi station in the pharmacy area
Select your desired language at top right screen, if desired (default to English, Spanish available)
Select “Complete All Tests” to get started
Select “Create My FREE Account” and enter email address
Select “Next” to move on
Create an account password (Check the “Show Password” box to see password)
Select “Next” to move on
Review your information for accuracy and confirm account details
Agree to the Terms of Use and Privacy Policy
Select “Sign Up” to move on
Select gender and enter your birth date using the format MM/DD/YYYY
Place your arm in the cuff as seen on the screen
Select “Begin” to start the test
Cuff will begin to inflate, remain still and calm to ensure accurate results
Systolic, diastolic and pulse results are shown
Select “Continue” to move on or “Redo” to re-take the test to get an average reading
Enter height in feet and inches
Sit in the middle of the seat as seen on the screen and select “Begin” when you are ready to start the test
Weight and BMI results are displayed, select “Continue”Session is complete
A summary of the session and the current higi score are displayed
Email results or select “Finish Session” to end the session

How long will it take to obtain results?

< 3 minutes

Key Features

Higi allows patients to share health data with their healthcare providers.
After consent, doctors, pharmacists, wellness providers and more can have access to records
Various self-service body measurements are available in addition to health education and risk assessments.
Higi stations can be readily accessed in grocery stores and pharmacies.

How to get started & Cost

For general questions
- Contact by phone: 866.818.8793 or email: support@higi.com.
To purchase a machine
- An inquiry form must be completed to obtain the cost and see if Higi is right for you.
To get started with your machine you can

Visit this manual on how to use Higi and frequently ask questions.

Billing

Free

Summary

Tests Performed	Weight, blood pressure, pulse, and body mass index (BMI).
Type of Machine	Health station screener
CLIA Waived?	No
Time to result	<3 minutes
Size	440 lbs (199.6 kg)
Price	An inquiry form must be completed to obtain the cost and see if Higi is right for you.
Key Feature	Easy access and data can be stored and shared with healthcare providers if desired
How to get started	Visit this link for step-by-step instructions

INSTi - HIV

What is it?

INSTI is an HIV-1 / HIV-2 Antibody Test manufactured by bioLytical laboratories. It is a one-time use, rapid, visually read test. Upon collection of sample, an accurate result will be available in 1 minute. It is highly specific with unparalleled accuracy when compared to standard HIV laboratory tests. (NOT APPROVED IN THE US)

This machine can perform tests for:

HIV-1 / HIV-2 Antibody

This machine is CLIA waived

How does it work?

It works by a flow-through immunoassay that detects antibodies to Human Immunodeficiency Virus (HIV) Type 1 and Type 2 using a drop of human fingerstick blood.

How do I use it

Collect blood by using the lancet to prick finger and collect a drop of blood
Add blood into bottle 1 and shake
Shake and pour solutions one at a time
Results available within 1 minute

How long does it take to obtain results?

1 minute

Key Features

Fast and accurate results

Readily accessible training with representatives available to help
NSTI Test kits have a shelf life of 15 months when manufactured
Unlike other HIV tests, no additional timing devices are required for results
An individual may test positive with the INSTI Test in as little as 21-22 days after infection, however depending on the person it can take as long as 3 months for them to produce sufficient antibodies.

How to get started & Costs

For general questions
- Contact customer support via email at customercare@bioLytical.com or at 1 866 674 6784
- Additional support is available with submitting a customer support form.
To purchase a machine
- An inquiry form must be completed to obtain the cost and see if Higi is right for you.
To get started with your machine you can
- Visit this link for a training video.

Billing

Not approved in the United States

Summary

Tests Performed	HIV-1 / HIV-2 Antibody
CLIA Waived?	Yes
Time to result	1 minute
Accuracy	Sensitivity >99% Specificity > 99%
Price	Not approved in US
Key Feature	Fasts and discrete tests. Unparalleled speed and accuracy in all patient settings
How to get started	Visit this link for a training video.

AdexusDx Analyzer

What is it?

The ADEXUSDx® Analyzer by Omnica is a small, portable analyzer that can provide point-of-care blood analysis with ADEXUSDx® test cassettes. It can be used by healthcare professionals trained and certified to use the ADEXUSDx® System. Samples can be obtained from saliva or blood from finger stick tests with a collection device. Many tests are available for research use only and those in the market include COVID-19 and hCG.

This machine can perform tests for:

COVID-19
hCG

This machine is CLIA waived for COVID-19 tests

How does it work?

The ADEXUSDx® COVID-19 Test is an in vitro lateral-flow immunoassay for qualitative detection of total antibodies to SARS-CoV-2 in human venous whole blood (dipotassium EDTA), plasma (dipotassium EDTA), serum, and fingerstick whole blood.

The ADEXUSDx® hCG Test is an immunoassay for the qualitative detection of human chorionic gonadotropin in human whole blood, plasma, or serum to aid in the diagnosis of early pregnancy.

How to use it:

ADEXUSDx® COVID-19 fingerstick method:

Perform finger stick
Touch the drop of blood to the top of the test
Set timer for 15 minutes and read result

ADEXUSDx® COVID-19 transfer device method:

Collect 40uL of sample using a liquid transfer device
Apply sample to the test
Set timer for 15 minutes and read result

ADEXUSDx® hCG fingerstick method:

Perform finger stick
Touch the drop of blood to the top of the test
Set timer for 10 minutes and read result

ADEXUSDx® hCG transfer device method:

Collect 40uL of sample using a liquid transfer device
Apply sample to the test
Set timer for 10 minutes and read result

How long will it take to obtain results?

15-30 minutes for COVID-19

10-30 minutes for hCG

Key Features

Fingerstick with lab accurate results
Easy to use
Low cost per test

How to get started & Costs

For general questions
- Contact by phone: 479.966.4535 or email: cc@nowdx.com.
To purchase a machine
- Purchases range depending on how many tests are needed.
- Orders can be placed here.
To get started with your machine you can
- Product resources for hCG test can be found here.

Product resources for COVID-19 test can be found here.

Summary

Tests Performed	COVID-19 & hCG
CLIA Waived?	Yes only for COVID-19 test
Time to result	15-30 minutes for COVID-19 10-30 minutes for hCG
Price	COVID-19 Test starting at $250 (box of 25) hCG Test starting at $150 (box of 25)
Key Feature	Easy to use with kow cost per test.
How to get started	Product resources for hCG test can be found here. Product resources for COVID-19 test can be found here.

Testing Devices

About CLIA

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Abbot ID Now

What is it?

How does it work?

How do I use it?

How long will it take to obtain results?

Key Features

This machine can perform tests for:

How is it Billed?

How to get started & Cost

Summary

BD Veritor Plus System

What is it?

How does it work?

How do I use it?

How long will it take to obtain results?

Key Features

This machine can perform tests for:

How is it billed?

How to get started & Cost

Summary

LumiraDx

What is it?

How does it work?

How do I use it?

How long will it take to obtain results?

Key Features

This machine can perform tests for:

How is it billed?

How to get started & Cost

Summary

GeneXpert Xpress

What is it?

How does it work?

How do I use it

How long does it take to obtain results?

Key Features

This machine can perform tests for:

How is it billed?

How to get started & Cost

Summary

Quidel Sofia 2 Flourescent Immunoassay Analyzer

What is it?

How does it work?

How do I use it?

How long will it take to obtain results?

This machine can perform tests for:

Key Features

How to Get Started & Cost

How is it Billed?

Summary

Siemens Clinitek Status + Urine Analyzer

What is it?

How does it work?

How do I use it?

How long will it take to obtain results?

Key Features

How to get started & Cost

How is it Billed?

Summary

Cobas Liat System

What is it?

This machine can perform tests for:

This machine can perform tests for:

How does it work?

How to use it?

How long will it take to obtain results?

Key Features

How to get started & Cost

Specific Remarks:

How is it billed?

Summary

OraSure Technologies

What is it?

This machine can perform tests for:

How does it work?

How do I use it?

How long does it take to obtain results?