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?

  1. Nasal swab is taken
  2. Swab is placed into an acidic solution and heated to 132.8 degrees F, exposing the virus
  3. 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. 

 

 

  • 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

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?

  1. Gather materials and label test device with specimen ID
  2. Remove cap from extraction reagent tube
  3. Insert patient sable sway and plunge the swab up and down for 15 seconds
  4. Remove the swab while squeezing the tube to extract liquid. 
  5. Press the dispensing tip on the tube firmly. Mix sample.
  6. Analyze now mode or walk away mode can be used 
  7. 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
  • To purchase
  • 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?

  1. Prep sample by obtaining a nasal, nasopharyngeal swab, or blood sample and mixing the sample in a provided tube
  2. Insert the test strip and select the test you want to run on the machine
  3. 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

 

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?

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 do I use it

  1. Obtain a swab specimen
  2. Transfer the sample to a cartridge
  3. 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
  1. Log into the Sofia 2 machine and enter the patient ID via touchscreen or barcode scan
  2. 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
  3. 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
TestSample TypeCLIA StatusTime to Results
SarsNasal, Nasopharyngeal swabWaived15 minutes
Flu A+BNasal, Nasopharyngeal swabWaived15 minutes
RSVNasal, Nasopharyngeal swab, aspirateWaived3-15 minutes
StrepThroat swabWaived5 minutes
Lyme DiseaseFingerstick whole bloodWaived3-15 minutes
Flu + SARSNasal, Nasopharyngeal swabWaived15 minutes
hCGUrine SampleModerate Complexity3 minutes
CampylobacterFecal SampleModerate Complexity15 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

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?

  1. Patient urine sample is appropriately collected
  2. Reagent strip is placed in a urine sample
  3. 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?

  1. Patient sample is obtained and added to the appropriate assay tube with the provided transfer pipette
  2. Place the assay tube under the built-in barcode scanner and then insert the assay into the device
  3. 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 HIV20 minutes
InteliSwab Covid-1930 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
  • CPT code for ORAQUICK ADVANCE: G0433QW
  • CPT codes for ORAQUICK: 86803QW, G0472QW
  • CPT code for InteliSwab: 87426

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

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.

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

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.

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

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”

  • Results in 10 minutes
  • Highly accurate and easy to use
  • Equipment is not required
  • 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
  • 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
HCPCS U0001 for RT-PCR and U0002 for any other technique

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

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.

  • Total Cholesterol
  • HDL cholesterol
  • Triglycerides
  • Glucose

 

This machine is CLIA waived

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

Reflectance Test – for lipid testing

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

Electrochemical Test – for blood glucose

  1. Turn on the analyzer, insert MEMo chip, and insert strip into designated electrochemical test strip slot
  2. 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

90 Seconds

  • 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
  • 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

 

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

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

Cholesterol

Sensitivity = 76%

Specificity = 93%

HDL Cholesterol

Sensitivity = 87%

Specificity = 93%

Triglycerides

Sensitivity = 98%

Specificity = 99%

Afinion 2

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.
  • HbA1c
  • Lipid Panel
  • ACR
  • CRP

 

This machine is CLIA waived for all tests

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

A1C

In as little as 3 minutes

%

ACR

In as little as 5 minutes

mg/g

  • 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
  • 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

CPT code(s) 83036QW for A1C

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

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.
  • Total Cholesterol
  • Triglycerides
  • Glucose

 

This machine is CLIA waived for all tests

Lipid panel utilizes spectroscopy while the glucose reading uses an electrochemical test
  1. Insert test strip at the bottom of the device and enter the power button
  2. Prick finger with lancet and use capillary rod to obtain a blood sample
  3. Place the lancet on the test strip at a 45 degree angle and wait until you hear a beep
  4. Wait 3 seconds to 2 minutes for 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)

  • 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
  • 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

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

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

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.
  • Total Cholesterol
  • Triglycerides
  • Glucose

 

this machine is CLIA waived for all tests

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

Spectroscopy Test – for lipid profile testing

  1. 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
  2. Obtain 5 microliters of a patient sample of blood via fingerstick and drop it onto the test strip via capillary tube
  3. Results will appear in 2 minutes

Electrochemical Test – for blood glucose testing

  1. Turn on the analyzer and insert strip into designated electrochemical test strip slot
  2. 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
  3. Results will appear in 3 seconds

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)

  • 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

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

  • For questions
  • 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

 

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+

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.

  • HbA1C

 

This machine is CLIA waived

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

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

  • 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

 

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

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. 

  • INR
  • Prothrombin Time (PT)

 

This machine is CLIA waived for all tests

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

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

Use CPT code 85610QW

  • For questions
  • 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

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

  • Total Cholesterol
  • HDL cholesterol
  • Triglycerides
  • Glucose

 

This machine is CLIA waived for all tests

  • LDL cholesterol
  • TC/HDL ratio
  • LDL/HDL ratio
  • non-HDL cholesterol
  • 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
  1. Perform a fingerstick and collect 40 microliter of bloods within 10 seconds
  2. Dispense the sample into the testing cassette
  3. Insert the cassette and press the RUN button
  • #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

Please see this link for reimbursement rates and CPT codes

  • 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

For product training, visit this link

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

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).

  • Weight
  • Blood pressure
  • Pulse
  • BMI

 

This machine is not CLIA waived

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.

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

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

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)



HIV-1 / HIV-2 Antibody

This machine is CLIA waived

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.

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

Not approved in the United States

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

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.

  • COVID-19
  • hCG

This machine is CLIA waived for COVID-19 tests

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.

ADEXUSDx® COVID-19 fingerstick method:

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

ADEXUSDx® COVID-19 transfer device method:

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

 

ADEXUSDx® hCG fingerstick method:

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

 

ADEXUSDx® hCG transfer device method:

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

15-30  minutes for COVID-19

10-30 minutes for hCG

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

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.

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