COVID-19 lgG/lgM Rapid Test Kit

April 2020

COVID-19 lgG/lgM Rapid Test Kit

Abstract

COVID-19 IgG/IgM Rapid Test is a

10 minute point-of-care test device for the

qualitative detection of IgG and IgM

antibodies specific to 2019-nCoV in human

whole blood.

IMPORTANT:This test is pending review by the FDA.

This test is not for the screening of donated blood.

This test is for research use only or for emergency use

during the COVID19 pandemic.

This test must be performed under supervision of a qualified

healthcare professional.

What's included inthe Kit?

Test CassetteLancet Dropper

Instruction InsertAlcohol Prep Pad

What additionalsupplies will youneed?

Capillary TubesTimer

Pipette

COVID-19 lgG/lgM Rapid Test

Important Information

Use Instructions

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10-Minute Rapid Result COVID-19 Test Kit Informational Packet ABOUT THE TEST AND COVID 19 (2019nCoV)

The Test In response to the global pandemic caused by 2019n-CoV, the “COVID19 IgG/IgM Rapid Test Cassette” was developed. It is a 10-minute, simple field test using a lateral flow immunoassay who’s ease of use allows for even minimally trained field personnel to perform. The test detects the presence of IgG and IgM antibodies specific to 2019n-CoV (detected in China in 2019) which is generally available in whole blood/serum/plasma after infection with the virus. COVID 119 (2019nCoV) In early January 2020, a novel (new) coronavirus (2019-nCoV) was identified as the infectious agent that was causing an outbreak of viral pneumonia in China. The first cases had an onset of symptoms in December 2019, one month before official outbreak status.1 Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds. They cause respiratory, enteric, hepatic, and neurologic diseases.2 Six coronavirus species are known t o cause human disease.3 Four viruses — 229E, OC43, NL63, and HKU1 — are prevalent and typically cause common cold symptoms in immunocompetent individuals.3 The two other strains — severe acute respiratory syndrome coronavirus (SARS-COV) and Middle East respiratory syndrome coronavirus (MERS-COV) — are zoonotic in origin and have been linked to sometimes fatal illness.4 Coronaviruses are zoonotic, which means they can be transmitted between animals and people. Common signs of infection include respiratory symptoms, fever, and cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death.5 Standard recommendations to prevent infection spread include regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with anyone showing symptoms of respiratory illness such as coughing and sneezing. 5

HOW THE TEST WORKS

The COVID19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane-based, lateral flow immunoassay for the detection of IgG and IgM antibodies to 2019-nCoV in whole blood, serum or plasma specimen. This test consists of two components, an IgG component, and an IgM component. IgG In the IgG component, anti-human IgG is coated in the IgG test line region on the membrane. During testing, when the specimen is added to the test cassette, it reacts with 2019-nCoV antigen-coated particles inside the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action, and it reacts with the anti-human IgG coated in the IgG test line region. If the specimen contains IgG antibodies to 2019-nCoV, a complex will be formed resulting in a colored line that will appear in the IgG test line region.

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IgM Similarly, anti-human IgM is coated in the IgM test line region and if the specimen contains IgM antibodies to 2019-nCoV, the conjugate-specimen complex reacts with anti-human IgM on the membrane. A colored line appears in IgM test line region as a result. Therefore, if the specimen contains 2019-nCoV IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains 2019-nCoV IgM antibodies, a colored line will appear in IgM test line region. Negative If the specimen does not contain 2019-nCoV antibodies, no colored line will appear in either of the test line regions, indicating a negative result. Control To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred, and the test has been activated correctly. Reagents The test contains anti-human IgM and anti-human IgG as the capture reagent, 2019-nCoV antigen as the detection reagent. A goat anti-mouse IgG is employed in the control line system.

PRECAUTIONS

1. Biohazard: Biological samples, such as blood, have the potential to transmit infectious diseases. It is important to follow all applicable local, state, and federal regulations.

2. Use routine laboratories precautions. Do not eat, drink or smoke in the area where the specimens or kits are handled.

3. Do not use the test if protective pouch is damaged. 4. For research use only. Do not use after expiration date. 5. Handle all specimens as if they contain infectious agents. Observe established precautions

against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.

6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

7. Please ensure that an appropriate amount of blood/reagent/buffer sample is used for testing. Too much or too little may lead to deviation of results.

8. Used test should be discarded according to local regulations. 9. Humidity and temperature can adversely affect results.

STORAGE AND STABILITY

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

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PROCEDURE This procedure should be completed by your healthcare worker who will administer the test,

interpret the result, properly document and report result to healthcare authorities in your state. Read this procedure in its entirety before attempting to perform the test.

Testing Preparation

• Whole blood collected by finger prick should be tested immediately.

• Testing should be performed immediately after the specimens have been collected.

• Do not leave the specimens at room temperature for prolonged periods.

• Bring specimens to room temperature prior to testing. Specimens should not be frozen and thawed.

• Specimens should not be shipped.

I. RUNNING THE TEST MATERIALS Provided:

• Test Cassette

• Lancet

• Dropper

• Instruction Insert

• Alcohol Prep Pad

Also necessary:

• Capillary Tubes

• Timer

• Pipette

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.

2. Place the cassette on a clean and level surface. 3. Prepare finger prick blood specimen:

a. To collect finger prick whole blood specimens i. Wash the patient’s hand with soap and warm water and then clean

the fingertip you will puncture with an alcohol swab. ii. Allow to dry.

iii. Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger

iv. Puncture the skin on the clean fingertip with a sterile lancet. v. Wipe away the first sign of blood.

vi. Gently rub the hand from wrist to palm to finger to form a rounded drop of blood at the puncture site.

b. To collect whole blood using venipuncture/preparation of serum and plasma:

i. Collect blood using general guideline for venipuncture. ii. Separate serum or plasma from blood as soon as possible to avoid

hemolysis. Use only clear non-hemolyzed specimens. Note: EDTA K2, Heparin sodium, Citrate sodium and Potassium Oxalate can be used as the anticoagulant for collecting the specimen.

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4. Collect Serum or Plasma specimen and apply to test cassette as described below. a. Hold the dropper vertically over the drop of blood. b. Draw the specimen to the fill line (approximately 10μL). c. Transfer the specimen to the specimen well (S) on the cassette.

5. Add 2 drops of buffer/reagent (approximately 80 μL). a. Set timer to 10 minutes, and annotate time.

6. After a 10-minute time lapse, healthcare worker should interpret results, properly document, and report to healthcare authority in your state.

INTERPRETATION

Read results at 10 minutes. Do not interpret the result after 20 minutes. Note: It is suggested not to use the buffer beyond 6 months after opening the vial.

QUALITY CONTROL Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

LIMITATIONS 1. The COVID19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is for invitro

diagnostic use only. This test should be used for detection of IgG and IgM antibody to 2019-nCoV in whole blood, serum or plasma specimens. Neither the quantitative value nor the rate of increase in the concentration of IgG or IgM antibodies to 2019-nCoV can be determined by this qualitative test.

2. The COVID19 IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma) will only indicate the presence of IgG and IgM antibodies to 2019-nCoV in the specimen, and should not be used as the sole criteria for the diagnosis of 2019-nCoV infections.

3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

4. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of 2019-nCoV infection. This is especially true if the infection occurred on or near the first day of infection.

5. The hematocrit level of the whole blood can affect the test results. Hematocrit level needs to be between 25% and 65% for accurate results.

6. The test will show negative results under the following conditions: a. The titer of the novel coronavirus antibodies in the sample is lower than the

minimum detection limit of the test, or the novel coronavirus antibody has not appeared at the time of sample collection (asymptomatic stage).

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PERFORMANCE CHARACTERISTICS Clinical Performance The clinical performance of the “COVID19 IgG/IgM Rapid Test Cassette” was evaluated in Shanghai, China with clinical samples derived from blood samples collected from 2019n-CoV infectious patients, and 2019n-CoV non-infectious patients, each confirmed by PCR. The study included testing of 20 known positive samples and 50 known negative samples.

• Of the 20 known positive samples, the IgG test yields a 100% agreement of 20 out of 20, while the IgM test yields an 85% agreement of 17 out of 20.

• Of the 50 known negative samples, the IgG test yields a 98% agreement of 49 out of 50, while the IgM test yields a 96% agreement of 48 out of 50.

• The data are illustrated in the table below.

SENSITIVITY AND SPECIFICITY IgG Results, Sensitivity, Specificity, and Accuracy

Method PCR Total Results COVID-19 Results Positive Negative

IgG/IgM Positive 20 1 21

Rapid Test Negative 0 49 49

Total Result 20 50 70

IgG test results yields 20 positive results, from 20 known positive samples. IgG test results yields 49 negative results, from 50 known negative samples. Relative Sensitivity: 100% (95%CI*: 86.0%-100%) *Confidence Interval

Relative Specificity: 98.0% (95%CI*: 89.4%-99.9%) Accuracy: 98.6% (95%CI*: 92.3%-99.96%) IgM Results, Sensitivity, Specificity, and Accuracy

Method PCR Total Results COVID-19 Results Positive Negative

IgG/IgM Positive 17 2 19

Rapid Test Negative 3 48 51

Total Result 20 50 70

IgM test results yields 17 positive results from 20 know positive samples. IgM test results yields 48 negative samples from 50 known negative samples. Relative Sensitivity: 85.0% (95%CI*: 62.1%-96.8%) *Confidence Interval Relative Specificity: 96.0% (95%CI*: 86.3%-99.5%) Accuracy: 92.9% (95%CI*: 84.1%-97.6%)

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Cross-reactivity The “COVID19 IgG/IgM Rapid Test Cassette” (Whole Blood/Serum/Plasma) has been tested against anti-influenza A virus, anti-influenza B virus, anti-RSV, anti-Adenovirus, HBsAg, anti-Syphilis, anti-H. Pylori, anti-HIV and anti-HCV positive specimens. The results showed no cross-reactivity. Interfering Substances The following compounds have been tested using the 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) and no interference was observed.

• Triglyceride: 50 mg/dL

• Ascorbic Acid: 20mg/dL

• Hemoglobin: 1000mg/dL

• Bilirubin: 60mg/dL

• Total cholesterol: 6mmol/L

BIBLIOGRAPHY 1.World Health Organization (WHO). WHO Statement Regarding Cluster of Pneumonia Cases in Wuhan, China. Beijing: WHO; 9 Jan 2020. [Accessed 26 Jan2020]. https://www.who.int/china/news/detail/09-01-2020-who-statement-regarding-cluster-of-pneumonia-cases-in-wuhan-china

2.Weiss SR, Leibowitz JL. Coronavirus Pathogenesis. Adv Virus Res 2011;81:85-164. PMID:22094080 DOI:10.1016/B978-0-12-385885-6.00009-2 3.Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016;24:490-502. PMID:27012512 DOI:10.1016/j.tim.2016.03.003 4.Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat RevMicrobiol 2019;17:181-192.PMID:30531947 DOI:10.1038/s41579-018-0118-9 5.World Health Organization (WHO). Coronavirus. https://www.who.int/health-topics/coronavirus 6.Biolab Sciences. The COVID IgG/IgM Rapid Test; Jaime Leija; April 4, 2020

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The COVID19 IgG/IgM Rapid Test Information and Disclaimer Please read, sign, and return to info@naturalandregenerative.com

The COVID19 IgG/IgM Rapid Test is a 10 minutes instant point-of-care test device for the qualitative detection of IgG and IgM antibodies specific to 2019-nCoV in human whole blood, serum or plasma specimens.

IMPORTANT

• This test is pending review by the FDA.

• This test is not for the screening of donated blood.

• This test is officially for research use only or for emergency use during this pandemic.

• This test is to be administered, interpreted, documented, and reported by a qualified healthcare worker.

INTENDED USE The COVID19 IgG/IgM Rapid Test Cassette is intended to be used in conjunction with other test and/or clinical and epidemiological information, e.g. if test is positive, the tested will require further diagnostic testing:

• For the in vitro qualitative detection of IgM and IgG antibodies specific to 2019n-CoV (detected in China in 2019) in whole blood/serum/plasma collected directly from symptomatic patients. The test may cross react with other viruses not tested for.

• For the presumptive identification of viral infections in patients who may be infected with 2019nCoV (detected in China in 2019) in conjunction with clinical and epidemiological risk factors.

• The test may cross react with other viruses not tested for.

• To provide epidemiologic information for surveillance of 2019n-CoV (detected in China in 2019).

Testing with the COVID19 IgG/IgM Rapid Test Cassette should only be performed in conjunction with other laboratory approved testing and/or clinical observations for the presumptive identification of viral infections in patients who may be infected with 2019nCoV (detected in China in 2019).

NOTE: The USFDA updated their guidance, issued on March 16, 2020, to allow the distribution of this product for diagnostic use in laboratories or by healthcare workers at point-of-care facilities. All test results are presumptive and should be confirmed by an approved molecular assay. A presumptive negative test does not preclude 2019n-CoV infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, a presumptive positive result does not rule out infections caused by other viruses.

What this means for you:

Your company will need to contract with a qualified medical professional in your state who will administer the

test, interpret the result, and properly report the results of the test to your state and or federal medical authority. It is the sole responsibility of your company to comply with these state and federal mandates as Natural and Regenerative IMS will be held harmless should you opt not to do so. By purchasing this product, you agree to these terms. *Should you require help to find a medical professional who can help, please let us know. We will compile a list for you.

I, ____________________, representing my organization, _____________________, have read and

understood all of the information that has been thoughtfully provided for me in pages 1 through 7 of

this document.

Signature: ___________________________________ Date: _____________________

initial

here:

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Coding

Reporting

Billing

ICD-10-CM Official Coding and Reporting Guidelines

April 1, 2020 through September 30, 2020

1. Chapter 1: Certain Infectious and Parasitic Diseases (A00-B99) g. Coronavirus Infections 1) COVID-19 Infections (Infections due to SARS-CoV-2)

a) Code only confirmed cases Code only a confirmed diagnosis of the 2019 novel coronavirus disease (COVID-19) as documented by the provider, documentation of a positive COVID-19 test result, or a presumptive positive COVID-19 test result. For a confirmed diagnosis, assign code U07.1, COVID-19. This is an exception to the hospital inpatient guideline Section II, H. In this context, “confirmation” does not require documentation of the type of test performed; the provider’s documentation that the individual has COVID-19 is sufficient. Presumptive positive COVID-19 test results should be coded as confirmed. A presumptive positive test result means an individual has tested positive for the virus at a local or state level, but it has not yet been confirmed by the Centers for Disease Control and Prevention (CDC). CDC confirmation of local and state tests for COVID-19 is no longer required. If the provider documents "suspected," "possible," "probable," or “inconclusive” COVID-19, do not assign code U07.1. Assign a code(s) explaining the reason for encounter (such as fever) or Z20.828, Contact with and (suspected) exposure to other viral communicable diseases.

b) Sequencing of codes When COVID-19 meets the definition of principal diagnosis, code U07.1, COVID-19, should be sequenced first, followed by the appropriate codes for associated manifestations, except in the case of obstetrics patients as indicated in Section . I.C.15.s. for COVID-19 in pregnancy, childbirth, and the puerperium.

For a COVID-19 infection that progresses to sepsis, see Section I.C.1.d. Sepsis, Severe Sepsis, and Septic Shock See Section I.C.15.s. for COVID-19 in pregnancy, childbirth, and the puerperium

c) Acute respiratory illness due to COVID-19

(i) Pneumonia For a pneumonia case confirmed as due to the 2019 novel coronavirus (COVID-19), assign codes U07.1, COVID-19, and J12.89, Other viral pneumonia.

(ii) Acute bronchitis For a patient with acute bronchitis confirmed as due to COVID-19, assign codes U07.1, and J20.8, Acute bronchitis due to other specified organisms. Bronchitis not otherwise specified (NOS) due to COVID-19 should be coded using code U07.1 and J40, Bronchitis, not specified as acute or chronic.

(iii) Lower respiratory infection If the COVID-19 is documented as being associated with a lower respiratory infection, not otherwise specified (NOS), or an acute respiratory infection, NOS, codes U07.1 and J22, Unspecified acute lower respiratory infection, should be assigned. If the COVID-19 is documented as being associated with a respiratory infection, NOS, codes U07.1 and J98.8, Other specified respiratory disorders, should be assigned.

(iv) Acute respiratory distress syndrome For acute respiratory distress syndrome (ARDS) due to COVID-19, assign codes U07.1, and J80, Acute respiratory distress syndrome.

d) Exposure to COVID-19 For cases where there is a concern about a possible exposure to COVID-19, but this is ruled out after evaluation, assign code Z03.818, Encounter for observation for suspected exposure to other biological agents ruled out. For cases where there is an actual exposure to someone who is confirmed or suspected (not ruled out) to have COVID-19, and the exposed individual either tests negative or the test results are unknown, assign code Z20.828, Contact with and (suspected) exposure to other viral communicable diseases. If the exposed individual tests positive for the COVID-19 virus, see guideline a).

e) Screening for COVID-19 For asymptomatic individuals who are being screened for COVID-19 and have no known exposure to the virus, and the test results are either unknown or negative, assign code Z11.59, Encounter for screening for other viral diseases. For individuals who are being screened due to a possible or actual exposure to COVID-19, see guideline d). If an asymptomatic individual is screened for COVID-19 and tests positive, see guideline g).

f) Signs and symptoms without definitive diagnosis of COVID-19 For patients presenting with any signs/symptoms associated with COVID-19 (such as fever, etc.) but a definitive diagnosis has not been established, assign the appropriate code(s) for each of the presenting signs and symptoms such as: • R05 Cough • R06.02 Shortness of breath • R50.9 Fever, unspecified

If a patient with signs/symptoms associated with COVID-19 also has an actual or suspected contact with or exposure to someone who has COVID-19, assign Z20.828, Contact with and (suspected) exposure to other viral communicable diseases, as an additional code. This is an exception to guideline I.C.21.c.1, Contact/Exposure.

g) Asymptomatic individuals who test positive for COVID-19 For asymptomatic individuals who test positive for COVID-19, assign code U07.1, COVID-19. Although the individual is asymptomatic, the individual has tested positive and is considered to have the COVID-19 infection.

15. Chapter 15: Pregnancy, Childbirth, and the Puerperium (O00-O9A)

s) COVID-19 infection in pregnancy, childbirth, and the puerperium During pregnancy, childbirth or the puerperium, a patient admitted (or presenting for a health care encounter) because of COVID-19 should receive a principal diagnosis code of O98.5-, Other viral diseases complicating pregnancy, childbirth and the puerperium, followed by code U07.1, COVID-19, and the appropriate codes for associated manifestation(s). Codes from Chapter 15 always take sequencing priority.

New CPT® Code

• Most recently, the CPT Editorial Panel approved a new Category I Pathology and Laboratory code for novel coronavirus testing. This code is effective March 13, 2020.

• 87635 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19], amplified probe technique

• This is an early release code, so you will need to manually upload this code descriptor into your electronic health record system.

CPT 87635® will be a child code under parent code 87471 Infectious agent detection by nucleic acid (DNA or RNA); Bartonella henselae and Bartonella quintana, amplified probe technique in the 2021 CPT® code set. special edition CPT® Assistant is publicly available, which provides guidance for using this new code. Visit the AMA website for more information about this new code. AMA COVID 19 CODING/GUIDANCE

Billing for COVID-19 Evaluation and Testing

This document applies to Medicaid Fee For Service only

Provider One will be updated to accept the new code developed by CMS for testing of the novel coronavirus, COVID-19

Billing for COVID-19 Testing

The following codes have been created to bill for testing for COVID-19. The codes will take affect by April 1, however retroactive claims will be accepted from dated from February 4th forward.

• U0001- for CDC testing laboratories to test patients for SARS-CoV-2 • U0002 non-CDC laboratory tests for SARS-CoV-2/2019-nCoV (COVID-19)

Billing for COVID-19 Related Services

Currently, there are no specific ICD-10 codes to use when billing for services related to COVID-19. The CDC has provided the following coding guidelines for COVID-19.

Condition Related to COVID-19

Associated ICD-10 code Condition Related to

COVID-19 Associated ICD-10 code

Pneumonia confirmed as due to COVID-19

J12.89 Other viral pneumonia

AND

B97.29 Other coronavirus as the cause of diseases classified elsewhere.

Acute bronchitis confirmed as due to COVID-19

J20.8 Acute bronchitis due to other specified organisms

AND

B97.29, Other coronavirus as the cause of diseases classified elsewhere

Lower respiratory infection, not otherwise specified (NOS), or an acute respiratory infection

This should be assigned with code J22, Unspecified acute lower respiratory infection

AND

B97.29 Other coronavirus as the cause of diseases classified elsewhere

Bronchitis not otherwise specified (NOS) confirmed as due to COVID-19

J40 Bronchitis, not specified as acute or chronic

AND

B97.29, Other coronavirus as the cause of diseases classified elsewhere.

If the COVID-19 is documented as being associated with a respiratory infection, NOS

J98.8, Other specified respiratory disorders,

AND

B97.29, Other coronavirus as the cause of diseases classified elsewhere.

Cases with ARDS due to COVID-19

J80, Acute respiratory distress syndrome

AND

B97.29, Other coronavirus as the cause of diseases classified elsewhere

Possible exposure to COVID-19, but this is ruled out after evaluation

Z03.818, Encounter for observation for suspected exposure to other biological agents ruled out.

Actual exposure to someone who is confirmed to have COVID-19

Z20.828, Contact with and (suspected) exposure to other viral communicable diseases.

signs/symptoms (such as fever, etc.) and where a definitive diagnosis has not been established

R05 Cough • R06.02 Shortness of breath • R50.9 Fever, unspecified

Diagnosis code B34.2, Coronavirus infection, unspecified, would in generally not be appropriate for the COVID-19, because the cases have universally been respiratory in nature, so the site would not be “unspecified”

If the provider documents “suspected”, “possible” or “probable” COVID-19, do not assign code B97.29. Assign a code(s) explaining the reason for encounter (such as fever, or Z20.828)

This coding guidance has been developed by CDC and approved by the four organizations that make up the Cooperating Parties: the National Center for Health Statistics, the American Health Information Management Association, the American Hospital Association, and the Centers for Medicare & Medicaid Services.

https://www.cdc.gov/nchs/data/icd/ICD-10-CM-Official-Coding-Gudance-Interim-Advice-coronavirus-feb-20-2020.pdf

Pricing and Ordering Information

COVID-19 IgG/IgM Rapid Test Kit

10-Minute Results / Finger Prick Test

Kit Includes: instructions, alcohol pad, lancet, pipet, buffer, cartridge.

Sold in bundles of 25 Kits (25 kits minimum per order)

Price per Kit Order Qty $75 25-100

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