ASSURANCE AB TM

COVID-19 IgM/IgG Rapid Antibody Test

This Instructions For Use (IFU) represents a work-in-progress document that is e�ective for pre-Emergency Use Authorization (EUA) (noti�cation with pending EUA) product. Final IFU language and data for issued EUA will be as determined by the Food and Drug Administration (FDA) when EUA is issued.

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Predictive Laboratories, Inc. – Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test

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In Vitro Diagnostic

AB-COVID19

INTENDED USE The Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM/IgG antibodies to SARS-CoV-2 in human capillary whole blood (fingerstick), venous whole blood (EDTA), plasma (EDTA), or serum specimens from patients suspected of COVID-19 infection by a healthcare provider or who were exposed to an individual infected with COVID-19. The Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test should not be used as the sole basis for diagnosis.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate and high complexity tests. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. A CLIA categorization of this device would be consistent with other serology lateral flow moderate complexity devices.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test early after infection is unknown.

False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.

For prescription use only. For in vitro diagnostic use only. For emergency use authorization use only.

BACKGROUND Coronaviruses (CoV) are a large family of viruses that cause illness, typically upper respiratory infection, ranging from the common cold to more severe diseases such as Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses are zoonotic, meaning they are transmitted between animals and people. The viruses are typically transmitted through the air by coughing, sneezing and close personal contact.

An outbreak of respiratory illness of unknown etiology was initially reported to the World Health Organization (WHO) on December 31, 2019. Chinese authorities identified a novel coronavirus (2019-nCoV) which has resulted in thousands of confirmed human infections. Cases of severe illness and deaths have been reported. The International Committee for Taxonomy of Viruses (ICTV) renamed the virus SARS-CoV-2.

Patients with SARS-CoV-2 report a mild to severe respiratory illness with symptoms of: fever, cough, shortness of breath. There is an urgent need for rapid tests to manage the ongoing pandemic.

TEST PRINCIPLE The Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test is a lateral flow immunoassay that can detect IgM and IgG antibodies against the SARS-CoV-2

virus in human capillary whole blood (fingerstick), whole blood (EDTA), plasma (EDTA), or serum.

The Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test dual lane cassette consists of monoclonal mouse anti-human IgM and a monoclonal mouse anti-human IgG conjugated to colloidal gold and each embedded into the sample pad. These respectively react with the IgM and/or IgG SARS-CoV-2 antibodies, if present in human capillary whole blood (fingerstick), whole blood (EDTA), plasma (EDTA), or serum, forming conjugate/SARS-CoV-2 antibody complex. The test control is goat anti-mouse IgG, also conjugated to colloidal gold and embedded into the sample pad.

As the mixture migrates along the test strip, the conjugate/SARS-CoV-2 antibody complex is captured by recombinant SARS-CoV-2 antigen immobilized on a membrane forming a colored test line in each test region. There are two lanes, one for IgM antibody detection and one for IgG antibody detections. The test lines (T lines) indicate the specific antibody. Each lane contains a control line (C line). The test control lines are specific indicators that the test is functioning correctly and will appear in both lanes. The IgM test line and/or IgG test line will appear when there is the presence of antibodies in the sample. The cassette is dual-targeted, with IgM and IgG detected in the same cassette, but physically separated, testing each antibody independently.

The Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test takes less than five (5) minutes to collect the specimen, and results are displayed as pink lines forcontrol (all samples) and a pink line for IgM and/or IgG antibody positive samples.The lines will appear within 15 minutes after application to the cassette. Any testline, no matter the intensity of the color, should be interpreted as positive. Both control lines must be visible, or the test is invalid, and retesting is required.

REAGENTS AND MATERIALS Reagents and Materials Provided Kit components provided below:

AB-COVID19 Kit Size (# of Tests) 50

Com

pone

nts Test Cassette 50

Collection Pipette 50 Diluent (0.5 oz. Bottle) 2

Instructions For Use 1 Quick Reference Guide 1

Materials Required but Not Provided 1. Alcohol Wipe 2. Sterile Gauze Pad 3. Gloves and other appropriate Personal Protective Equipment (PPE)4. Timer5. Blood collection supplies if testing venous samples6. Safety lancet if testing fingerstick samples

STORAGE AND HANDLING1. Store the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test kit

between 2-30°C.

Predictive Laboratories, Inc. – Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test

PL-DOC-000881 v7 Rev 2020-06-09 Page 3 of 5

2. DO NOT USE beyond the expiration date listed on the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test kit.

3. Bring the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test kit to room temperature before using.

4. Once the foil pouch has been opened, use the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test kit within one (1) hour.

SPECIMEN COLLECTION AND PREPARATION Consider any materials of human origin as infectious and handle using standard biosafety procedures. Prepare site for specimen collection following regular laboratory and/or clinical procedures.

Capillary Whole Blood (fingerstick) 1. Puncture the finger with a lancet.2. Wipe off the first drop of blood using sterile gauze pad.3. Collect blood in provided pipette (sufficient for two drops, ~ 20 µl).

Whole Blood (EDTA)1. Collect blood specimen in lavender EDTA Vacutainer®.2. Mix thoroughly by inversion.3. Collect blood in provided pipette (sufficient for two drops, ~ 20 µl).

Plasma (EDTA)1. Collect blood specimen in lavender EDTA Vacutainer®.2. Mix thoroughly by inversion.3. Separate the plasma by centrifugation.4. Remove an aliquot into a new labeled separate container.5. Collect plasma from secondary container using provided pipette (sufficient

for two drops, ~ 20 µl).

Serum 1. Collect blood specimen in red top Vacutainer® (no anticoagulants).2. Separate the serum by centrifugation.3. Remove an aliquot into a new labeled separate container.4. Collect serum from secondary container using provided pipette (sufficient

for two drops, ~ 20 µl).

TEST PROCEDURE (SAMPLE COLLECTION VIDEO AT WWW.PREDICTIVELABS.COM)

Step 1: Open the foil pouch containing the test cassette. Place the cassette on a flat surface near the site where you are collecting the blood sample.

Step 2: The cassette should be used as soon as possible. Use the cassette within one (1) hour after opening.

Step 3: Open the diluent vial and place near the test cassette. Step 4: Using the pipette that the specimen was collected in dispense one (1)

drop blood (~10 µl) into EACH sampling well on the test cassette (labeled “S”).

Step 5: Immediately dispense 2 drops of diluent into each sampling well on the test cassette (labeled “S”).

Step 6: Set up a timer. Step 7: Read the results in 15-20 minutes.

Test results should not be interpreted before 15 minutes following addition of the diluent. DO NOT interpret the test results after 20 minutes of applying the diluent.

QUALITY CONTROL Each device has an internal control embedded within the test cassette. The test control line (C line) is a specific indicator that the test is functioning correctly and will appear in all tested individuals. Absence of one or both control lines, no matter what other lines are present, constitutes an invalid test.

External positive and negative controls should be used under the following circumstances:

1. A new operator is using the kit, 2. A new lot or shipment of test kits is used, 3. To investigate unusual results such as a change in positive, negative or

invalid test rates.

Predictive Laboratories and authorized distributor(s) will make the external control materials available for purchase at the same time as the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test kit. Institutions may also use their own authorized controls.

INTERPRETATION OF RESULTS Valid Assay

IgM Positive/IgG Positive: IgG test line, IgM test line and control lines appear on the membrane.

The patient has been exposed to the SARS-CoV-2 virus and is developing likely immunity.

IgM Positive/IgG Negative: IgM test line and control lines appear on the membrane.

The patient has developed an initial antibody response, indicating recent exposure to the SARS-CoV-2 virus. IgG antibodies have not yet developed to the SARS-CoV-2 virus.

IgM Negative/IgG Positive: IgG test line and control lines appear on the membrane.

The patient has been exposed to the SARS-CoV-2 virus, but acute infection is unlikely.

IgM Negative/IgG Negative: Only the control lines appear on the membrane.

The patient has not yet developed antibodies to the SARS-CoV-2 virus. This result may be seen at the early stage of infection or may indicate no exposure to the virus.

Invalid Assay – if either or both of the control lines do not develop, the assay is invalid regardless of color development of the IgM or IgG lines. Repeat the assay with a new device.

PERFORMANCE CHARACTERISTICS 1. Clinical PerformanceThe clinical studies included 400 serum samples from SARSCoV-2 viral positive (n=287) and SARSCoV-2 viral negative (n=113) patients. The 287 viral positive patients had symptoms consistent with COVID-19. The 113 viral negative patients included 75 (66.40%) patients displaying upper respiratory symptoms and who

Predictive Laboratories, Inc. – Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test

PL-DOC-000881 v7 Rev 2020-06-09 Page 4 of 5

were referred for COVID- 19 viral testing, 36 (31 .9%) healthy adults being seen for wellness checkups and 2 patients (1.7%) of individuals with co-morbidities that put them at higher risk for COVID- 19.

An additional 500 independent serum samples collected for another purpose before the epidemic started (all have tested negative for COVID-19 antibodies by reference methods) were included. The clinical and demographic characteristics of this sample cohort are not available.

Agreement with a composite reference method The performance of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test was compared to a composite reference method that includes a RT-PCR method and a chemiluminescence immunosorbent assay (CLIA). A total of 900 serum samples (287 positive and 613 negative) were tested with the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test and compared to a composite reference method. The agreement results are presented in the table below.

Comparator (RT-PCR) Subtotal

Pos Neg Assurance

AB™ COVID-19 IgM/IgG

Rapid Antibody Test

Pos IgG+/IgM+ 15 0 15 IgG-/IgM+ 31 0 31 IgG+/IgM- 221 0 221

Neg IgG-/IgM- 44 613* 657 Subtotal 311 613 924

*Includes 500 pre-pandemic stored serum samples

Positive Percent Agreement (PPA): 267/311 (85.9%); (95% CI: 81.5 – 89.5%) Negative Percent Agreement (NPA): 613/613 (100.0%); (95% CI: 99.4 -100.0%)

Agreement with a chemiluminescence immunosorbent assay (CLIA) A total of 900 samples were tested comparing the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test to a reference antibody test. The agreement results of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test to an antibody reference assay are presented below.

IgM Agreement Comparator

(CLIA) Subtotal Pos Neg

Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test

Pos 44 2 46

Neg 5 873 878

Subtotal 49 875 924 Positive Percent Agreement (PPA): 44/49 (89.8%); (95% CI: 77.8-96.6%) Negative Percent Agreement (NPA): 873/875 (99.8%); (95% CI: 99.2-100%)

IgG Agreement Comparator

(CLIA) Subtotal Pos Neg

Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test

Pos 230 6 236

Neg 21 667 688

Subtotal 251 673 924 Positive Percent Agreement (PPA): 230/251 (91.6%); (95% CI: 87.5-94.8%) Negative Percent Agreement (NPA): 667/673 (99.1%); (95% CI: 98.1-99.7%)

2. Cross-reactivity Cross-reactivity of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test was evaluated using serum samples confirmed with clinical infections other than COVID-19. A total of one hundred thirteen samples (n=113) were obtained from two centers, Nanjiang Gulou Hospital and the Jiangsu Provincial Public Health

Center. Cross-reactivity was examined across a wide range of clinical diagnoses including influenza A and B, hepatitis B and C virus and respiratory syncytial virus types. In addition to these viruses, common seasonal coronaviruses HKU1, NL63, OC43 and 229E were also included. All samples tested negative for the SAR-CoV-2 virus by RT-PCR. All tested negative for both SARS-CoV-2 IgM and IgG antibodies. No cross-reactivity was observed with the following:

Clinical Diagnosis Adenovirus Human parainfluenza 4b type Bronchial pneumonia Human parainfluenza type 2 Capillary bronchopneumonia Human parainfluenza type 3 Chlamydia pneumonia Influenza A virus Common cold, fever Influenza B virus Enterovirus Interstitial pneumonia Epstein-Barr virus Mycobacterium tuberculosis Group B Streptococcus Mycoplasma pneumonia Hepatitis B virus Norovirus Hepatitis C virus Respiratory syncytial virus Herpes simplex virus Respiratory syncytial virus A type Human coronavirus HKU1 type Respiratory syncytial virus type B Human coronavirus NL63 type Rotavirus Human coronavirus OC43 type Rubella virus Human coronavirus type 229E Streptococcus pneumonia Human cytomegalovirus

3. Matrix-equivalency/Sample typesThe performance of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Testwas evaluated with different sample types. Ten (10) volunteers who were negative for both ARS-CoV-2 IgM and IgG antibodies were selected for collection of 4 different sample matrices e.g., venipuncture whole blood (EDTA), finger stick blood, serum, and plasma (EDTA). Each sample matrix (type), for each volunteer,was divided into three samples - two samples were spiked with positive serum at two concentrations (1:10 and 1:100) and one (1) sample was unspiked. Each sample was tested in duplicate.

The unspiked samples for each matrix from 10 volunteers showed no antibodies detected in any of the matrices. The 1:10 dilution of each sample, spiked with an IgM/IgG antibody positive sample, produced strong IgM and IgG test lines in 10/10 samples in all of the matrices. The 1:100 dilution of each sample, spiked with an IgM/IgG antibody positive sample, produced weak IgM and IgG test lines in all of the matrices collected from 10 volunteers. All four sample matrices collected from 10 volunteers showed equivalent results.

LIMITATIONS 1. Performance of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody

Test has only been established in human capillary whole blood (fingerstick), whole blood (EDTA), plasma (EDTA), or serum specimens. Other specimen types may give inaccurate results.

2. False negative results may occur if:a. A specimen is improperly collected or handled.b. Antibody titers are below levels of detection or have not fully developed

after exposure to the SARS-CoV-2 virus. c. The virus has undergone minor amino acid mutation(s) in the epitope

recognized by the antibody detected by the test. 3. The Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test cannot detect

or rule out diseases caused by other bacterial or viral pathogens.4. The Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test is limited to

the qualitative detection of antibodies specific for the SARS-CoV-2 virus. The intensity of the test line does not necessarily correlate to SARS-CoV-2 antibody titer in the specimen.

5. The results obtained with this test should only be interpreted in conjunction with clinical findings, and the results from other laboratory tests and evaluations.

6. If symptoms persist and the result from the qSARS-CoV-2 IgG/IgM Rapid Test is negative or non-reactive, it is recommended to re-sample the patienta few days later or test with an alternative test device.

7. This test should not be used for screening of donated blood.

Predictive Laboratories, Inc. – Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test

PL-DOC-000881 v7 Rev 2020-06-09 Page 5 of 5

WARNINGS 1. This Instructions for Use document must be read completely before

performing the test. Deviations from procedures, clinical specimen types, control materials, and materials required to use Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test may cause inaccurate test results.

2. All operators using the Assurance AB™ COVID-19 IgM/IgG Rapid AntibodyTest should be appropriately trained in performing the test, interpreting the results and using appropriate personal protective equipment.

3. Assay/Reagenta. DO NOT open the cassette foil pouch until ready for testing.b. DO NOT reuse processed cassettes. Tests are single use.c. DO NOT use a cassette if it appears wet or if the foil pouch appears to

have been opened.d. DO NOT use expired devices.

4. DO NOT use the components from another type of test kit as a substitute for components in this kit.

5. DO NOT mix components from other kit lots.6. Handle the external positive and negative controls in the same way that you

process the specimen.

HEALTH, SAFETY AND ENVIRONMENTAL PRECAUTIONS 1. Biological specimens, transfer devices, and used cassettes should be

considered capable of transmitting infectious agents requiring standard precautions. Follow your institution’s environmental waste procedures for proper disposal of used cassettes and unused reagents.

2. This test kit should be handled only by qualified personnel trained in laboratory procedures and familiar with their potential hazards. Wearappropriate protective clothing, gloves and eye/face protection and handle appropriately with the requisite Good Laboratory Practices.

3. For hazard and precaution recommendations related to diluent component, ProClin® 300 (0.1%), in this test kit, please refer to the symbol(s) shown on the labels and described below. The Safety Data Sheet is available at:www.sigmaaldrich.com.

H317: May cause allergic skin reaction. H412: Harmful to aquatic life with long lasting effects. P273: Avoid release to the environment. P280: Wear protective gloves/protective clothing/eye protection/face protection. P302 + P352: IF ON SKIN: Wash with plenty of soap and water. P333 + P313: If skin irritation or rash occurs: Get medical advice/attention. P501: Dispose of contents and container in accordance with local, regional, national, and international regulations. H314: Causes severe skin burns and eye damage. H290: May be corrosive to metals. P280: Wear protective gloves/protective clothing/eye protection/face protection. P301 + P330 + P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P501: Dispose of contents and container in accordance with local, regional, national, and international regulations.

GENERAL INFORMATION 1. Website: www.predictivelabs.com2. Email: info@predictivelabs.com

TECHNICAL ASSISTANCE 1. Before contacting Predictive Laboratories, collect the following information:

a. Product nameb. Lot number

2. Telephone Number: 1-888-585-15513. Email: info@predictivelabs.com

INDEX OF SYMBOLS

Symbol Meaning

Contents sufficient for 1 test

Store between 2-30°C

Consult instructions for use

Do not reuse

For in vitro diagnostic use only

Catalog number

Lot number

Use by date

Manufacturer

Warning – Skin/eye irritation or reaction

Hazardous to the aquatic environment, chronic hazard

Danger – Skin/eye damage, corrosive to metals

Predictive Laboratories, Inc. 2749 East Parleys Way, Suite 100 Salt Lake City, Utah 84109 Phone: 1-888-585-1551 Fax: 1-888-972-9124 (HIPAA Compliant) Website: www.predictivelabs.com