QUIDEL Solana SARS-CoV-2 Assay Instruction Manual

QUIDEL Solana SARS-CoV-2 Assay

INTENDED USE

The Solana SARS-CoV-2 Assay is an isothermal Reverse Transcriptase – Helicase- Dependent Amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high or moderate complexity tests. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 is generally detectable upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Solana SARS-CoV-2 Assay is intended for use by laboratory personnel who have received specific training on the use of the Solana SARS-CoV-2 Assay and/or the Solana Instrument. The Solana SARS-CoV-2 Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

SUMMARY AND EXPLANATION
SARS-CoV-2, also known as the COVID-19 virus, was first identified in Wuhan, Hubei Province, China December 2019. This virus, as with the novel coronavirus SARS-1 and MERS, is thought to have originated in bats, however the SARS-CoV-2 may have had an intermediary host such as pangolins, pigs or civets.1 On March 11, the WHO had declared the SARS-CoV-2 as a global pandemic. As of 13 December 2020, the number of new COVID-19 cases and deaths continued to rise with 70 million cumulative cases and 1.6 million deaths globally since the start of the pandemic. The Regions of the Americas and Europe continue to shoulder the burden of the pandemic, accounting for 85% of new cases and 86% of new deaths globally1. The median incubation time is estimated to be 5.1 days with symptoms expected to be present within 12 days of infection.2 The symptoms of COVID-19 are similar to other viral respiratory diseases and include fever, cough and shortness of breath.3 The Solana SARS-CoV-2 Assay has been designed to specifically detect SARS-CoV-2 RNA.

PRINCIPLE OF THE TEST
The Solana SARS-CoV-2 Assay amplifies and detects viral RNA present in nasopharyngeal or nasal swab specimens collected and placed into viral transport media. The assay consists of two major steps: (1) specimen preparation, and (2) amplification and detection of target sequences specific to SARS-CoV-2 using isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes. A patient nasal or nasopharyngeal swab specimen in viral transport media is transferred to a Process Buffer Tube, mixed, and subjected to heat treatment at 95°C for 5 minutes. The frozen Master Mix vial contains RT-HDA reagents, dNTPs, primers and probes. The thawed Master Mix is transferred to empty reaction tubes. The processed sample is then transferred to a Reaction Tube containing Master Mix. Once the Master Mix and the processed sample are mixed, the Reaction Tube is placed in Solana for amplification and detection of SARS- CoV-2 specific target sequences. In Solana, the target sequences are amplified by SARS-CoV-2 specific primers and detected by SARS-CoV-2 specific fluorescence probes, respectively. A competitive process control (PRC) is included in the Master Mix to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. In addition, the target probe and PRC probe have one or more bases that are comprised of ribonucleic acid. Upon annealing to SARS-CoV-2 or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on-board method- specific algorithms. Solana then reports the test results to the user on its display screen, and it can print out the results via an integrated printer.

MATERIALS PROVIDED

MATERIALS REQUIRED BUT NOT PROVIDED

• Sterile DNAse-free filter-blocked positive displacement micropipettor tips
• Micropipettor
• Stopwatch or timer
• Vortex Mixer
• Scissors or a blade
• Workflow tray
• Transfer Rack
• Heat block capable of 95°C ± 2°C temperature
• Thermometer
• Solana instrument (firmware version 2.0.11)
• Transport Media (BD/Copan UTM, CDC Viral Transport Media)
• Ultra-low temperature freezer -70°C or below

WARNINGS AND PRECAUTIONS

• For In Vitro Diagnostic Use under Emergency Use Authorization only.
• This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.
• This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
• All reagents are for in vitro diagnostic use only.
• Refer to the Solana Operator’s Manual for further information regarding instrument installation and operation.
• Only use the protocol described in this package insert. Deviations from the protocol may give erroneous results.
• Treat all specimen/samples as potentially infectious. Follow universal precautions when handling samples, this kit and its contents.
• All tubes should be capped tightly prior to vortexing.
• Proper sample collection, storage and transport are essential for correct results.
• Master Mix should remain frozen until use. Do not refreeze. Once thawed, Master Mix is stable for up to 24-hours when stored at 2° to 8°C.
• Store assay reagents as indicated on their individual labels.
• Reagents are not interchangeable between lots.
• Never pool reagents from different tubes even if they are from the same lot.
• Do not use the reagents after their expiration date.
• Do not interchange caps among reagents as contamination may occur and compromise test results.
• Only open the tubes when adding aliquots into tubes or removing aliquots from tubes. Keep the tubes closed at any other time to avoid contamination.
• For accurate results, pipette carefully using only calibrated equipment. Use of inaccurate volumes may give erroneous results.
• To avoid contamination of the environment with SARS-CoV-2 amplicons, do not open the reaction tubes post-amplification.
• Avoid microbial and ribonuclease (RNAse) contamination of reagents when removing aliquots from tubes.
• Performing the assay outside of the recommended time ranges can produce invalid results. Assays not completed within specified time ranges should be repeated.
• Additional controls may be tested according to guidelines or requirements of local, state, provincial and/or federal regulations or accrediting organizations.
• Do not pipette by mouth.
• Do not smoke, drink or eat in areas where specimens or kit reagents are being handled.
• Maintenance and decontamination of workspace and equipment should follow and be performed according to established laboratory protocols and schedules. Testing should be performed in an area with adequate ventilation.
• Dispose of containers and unused contents in accordance with Federal, State and Local regulatory requirements.
• Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this kit.
• Wash hands thoroughly after handling.
• For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please refer to the Safety Data Sheet (SDS) located at quidel.com.

STORAGE AND HANDLING OF KIT REAGENTS

Store the Master Mix at -70°C or below. Once thawed, the Master Mix is stable for up to 24-hours when stored at 2° to 8°C. The remaining Assay Kit should be stored at 2°C to 8°C until the expiration date listed on the outer kit box.

SPECIMEN COLLECTION, STORAGE AND HANDLING

Nasal and nasopharyngeal specimens should be collected, transported, stored, and processed according to CLSI M41-A4. Specimens collected in BD/Copan UTM are stable at room temperature (RT), 2°C to 8°C or -70°C or below for up to 4 days. Specimens collected in the CDC Viral Transport Medium should be stored at 2-8°C for up to 72 hours after collection or at -70°C or below if a delay in testing or shipping is expected.

TEST PROCEDURE

1. Turn on Solana by pressing the power button and wait until it completes self-testing.
   NOTE : Do not open the lid during the self-testing.

2. Place the required number of Process Buffer Tubes in the Workflow tray. Label the Process Buffer Tubes on the cap and/or side of the tube.
   NOTE : One (1) Process Buffer Tube is required for each specimen or control to be tested.
   NOTE : A maximum of 12 tests can be performed per test run in a single Solana instrument.

3. Remove the required number of Empty Reaction Tubes from the bag and place in the Workflow tray. Label the Reaction Tubes on the cap.

4. Mix the specimen received in viral transport media by vortexing the tubes for 5 seconds.

5. Remove 50 µL of the mixed specimen or External control and add to labeled Process Buffer Tubes and then vortex the Tubes for 5 seconds.

6. Heat the Process Buffer Tubes at 95 ±2°C for 5 minutes and then vortex the Tubes for 5 seconds.
   NOTE : Begin 5-minute lysis procedure after placing tubes in block and waiting until block returns to 95°C.
   NOTE : Samples are stable in process buffer up to 6-days at 2°C to 8°C, –20°C, and -70°C after the heat step.

7. Thaw one (1) Master Mix vial for every 12 tests you wish to perform for 13-15 minutes before proceeding to the next step. This may also be performed at beginning of test procedure if user intends to perform sample testing through amplification.

8. Only thaw the volume of Master Mix required to complete testing. 8. Mix thawed Master Mix for 5 seconds.

9. Add 25 µL of Master Mix to each empty reaction tube.

10. Add 25 µL of each heat lysed Process Buffer specimen to the corresponding Reaction Tube directly into the liquid Master Mix and mix by vigorously pipetting up and down 5 times. Firmly close the Reaction Tubes.

11. Using the Solana Transfer Rack to hold Reaction Tubes at eye-level, visually inspect each Reaction Tube to ensure there are no air bubbles present at the bottom of the tube and liquid levels are equivalent. Flick tube lightly to remove any air bubbles observed.
    NOTE : Only touch Reaction Tubes with gloved hands

12. Open the lid of the Solana instrument and place the Reaction Tubes in Solana via the Transfer Rack. Close the lid. NOTE: Be sure that all tubes are in tight contact with heat block.

13. Enter User ID, press ↵ (ENTER) and enter Password and press ↵ (ENTER).

14. Select “NEW TEST.” If Solana displays a different screen, go to the home screen.

15. Select the tube positions to use.

16. Scan the assay barcode or manually enter Lot ID/Exp Date, then select “SARS-CoV-2 Assay” from the Select Test drop-down menu and press “.”

17. Select sample type (patient or QC) from the drop-down menu and enter Sample IDs (optional; see 2nd Note in next step).

18. Press “Start” to initiate the Solana SARS-CoV-2 Assay. Solana will display the progress and the count-down to assay completion. Test results will be displayed on the screen in approximately 25 minutes.
    NOTE: To avoid laboratory contamination, once the tube has been closed and the amplification reaction started, DO NOT open the Reaction Tube.
    NOTE : While the test is running, sample ID can be entered or edited by pressing the pencil icon.

19.  After the run is completed the results can be printed by selecting the print button.
    NOTE : Do not navigate away from this screen before printing results. Once the screen is gone, it cannot be revisited. If this occurs, the results can be viewed individually by going to Home and then selecting Review Results. To determine if sample is positive for SARS-CoV-2, press the tube sample number.

INTERPRETATION OF RESULTS

The Solana software automatically determines the specimen results for SARS- CoV-2 virus. A positive result indicates that the viral RNA for the SARS-CoV-2 virus was detected. A negative result indicates that SARS-CoV-2 virus RNA was not detected, and the process control was detected. Solana reports a specimen result as invalid when both SARS-CoV-2 virus was not detected, and the process control was undetected. The process control (PRC) is used to monitor sample processing, to detect HDA inhibitory specimens, and to confirm the integrity of assay reagents and the operation of the Solana instrument.

Single Sample Results Screen

Assay Result| Interpretation
SARS-CoV-2 POSITIVE| SARS-CoV-2 RNA detected

SARS-CoV-2 NEGATIVE

|

No SARS-CoV-2 RNA detected/PRC detected

SARS-CoV-2 INVALID| No SARS-CoV-2 RNA and No PRC detected; for invalid test results, re-process another aliquot of the same sample or obtain a new sample and re-test.

QUALITY CONTROL

The Solana SARS-CoV-2 Assay incorporates several controls to monitor assay performance.

• A positive control (such as a positive patient sample) should be processed and tested with each batch of specimens.
• The process control (PRC) consists of single stranded RNA and is used to monitor HDA inhibitory specimens, and to confirm the integrity of assay reagents and the operation of the Solana instrument. The process control is included in the Reaction Tube.
• The external positive control (containing SARS-CoV-2 Synthetic RNA) may be treated as a patient specimen. The control should be sampled and tested as if it were a patient specimen and processed as described above in the Assay Procedure. The external positive control is intended to monitor substantial reagent and instrument failure.
• The external negative control may be treated as a patient specimen. The control should be sampled and tested as if it were a patient specimen and processed as described above in the Assay Procedure. The external negative control is used to detect reagent or environmental contamination (or carry-over) by SARS-CoV-2 RNA or amplicon.

It is recommended that the reactivity of each new lot and each new shipment of the Solana SARS-CoV-2 Assay be verified on receipt and before use. External control tests should be performed thereafter in accordance with appropriate federal, state and local guidelines. The Solana SARS-CoV-2 Assay should not be used in patient testing if the controls do not produce the correct results.

LIMITATIONS

• Negative results do not preclude infection with SARS-CoV-2 and should not be the sole basis of a patient treatment decision.
• The performance of this test was assessed using nasal and nasopharyngeal swab specimens in viral transport medium.
• Improper collection, storage or transport of specimens may lead to false negative results.
• Inhibitors present in the sample and/or errors in following the assay procedure may lead to false negative results.
• A trained health care professional should interpret assay results in conjunction with the patient’s medical history, clinical signs and symptoms, and the results of other diagnostic tests.
• Analyte targets (viral sequences) may persist in vivo, independent of virus viability. Detection of analyte target(s) does not imply that the corresponding virus(es) are infectious or that they are the causative agents for clinical symptoms.
• There is a risk of false positive values resulting from cross-contamination by target organisms, their nucleic acids or amplified product, or from non-specific signals in the assay.
• Based on the in-silico analysis, SARS-CoV and other SARS-like coronaviruses in the same subgenus (Sarbecovirus) as SARS-CoV-2 may cross-react with the Solana SARS-CoV-2 Assay. SARS-CoV is not known to be currently circulating in the human population, therefore is highly unlikely to be present in patient specimens.
• There is a risk of false negative values due to the presence of sequence variants in the viral targets of the assay.

CONDITIONS OF AUTHORIZATION FOR THE LABORATORY AND PATIENT CARE SETTINGS
The Solana SARS-CoV-2 Assay Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients, and authorized labeling are available on the FDA website:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19 -emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.
However, to assist clinical laboratories using the Solana SARS-CoV-2 Assay, the relevant Conditions of Authorization are listed below:

• Authorized laboratories1 using the Solana SARS-CoV-2 Assay will include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.
• Authorized laboratories using the Solana SARS-CoV-2 Assay will use the Solana SARS-CoV-2 Assay as outlined in the “Solana SARS-CoV-2 Assay” Instructions for Use. Deviations from the authorized procedures, including the authorized instruments, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use the Solana SARS-CoV-2 Assay are not permitted.
• Authorized laboratories that receive the Solana SARS-CoV-2 Assay will notify the relevant public health authorities of their intent to run the Solana SARS-CoV-2 Assay prior to initiating testing.
• Authorized laboratories using the Solana SARS-CoV-2 Assay will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.
• Authorized laboratories will collect information on the performance of the Solana SARS-CoV-2 Assay and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov) and Quidel (via email: QDL.COV2.test.event.report@quidel.com, or via phone by contacting Quidel Customer Support Services at 800.874.1517 (in the U.S.) or 858.552.1100) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of the Solana SARS-CoV-2 Assay of which they become aware.
• All operators using the Solana SARS-CoV-2 Assay must be appropriately trained in performing and interpreting the results of the Solana SARS-CoV-2 Assay, use appropriate personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling.
• Quidel Corporation, authorized distributors, and authorized laboratories using the Solana SARS-CoV-2 Assay will ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request.

CLINICAL PERFORMANCE

A study was performed comparing the Solana SARS-CoV-2 Assay to an authorized EUA RT-PCR assay. Two hundred forty (240) nasal swab samples and fifty-one (51) nasopharyngeal swabs in viral transport media were tested with both devices according to the respective package inserts. Two hundred four (204) samples were tested with the Solana assay after storage of the viral transport media at -70°C. Eighty-seven (87) were tested with the Solana assay after storage of the viral transport media at 2°C to 8°C.

Comparison of Solana SARS-CoV-2 Assay and an authorized EUA comparator assay

Specimen Type

| Number Tested| True Positive| False Positive| True Negative| False Negative|

PPA%

|

NPA%

|

PPA 95% CI

|

NPA 95% CI

Nasal Swabs| 240| 69| 0| 169| 2| 97.2| 100| 90.3% –

99.2%

| 97.8% –

100%

Nasopharyngeal Swabs| 51| 19| 1| 31| 0| 100| 96.9| 83.2% –

100%

| 84.3% –

99.5%

Combined Swabs| 291| 88| 1| 200| 2| 97.8| 99.5| 92.3% –

99.4%

| 97.2% –

99.9%

ANALYTICAL PERFORMANCE

LIMIT OF DETECTION
The Limit of detection (LoD) was established with BEI NR-52286, SARS-Related Coronavirus 2, Isolate USA-WA1/2020, Heat Inactivated in three (3) separate studies using dilutions in negative nasal matrix collected into UTM.

Study 1 – LoD Screen
Ten-fold dilutions of the heat-inactivated SARS-CoV-2 were made in negative nasal matrix. Each dilution was tested in triplicate with the Solana SARS- CoV-2 Assay. The last dilution with detectable RNA was used for the Pre-LoD testing.

LoD Screen Results

SARS-CoV-2 Concentration (cp/mL)| # Positive/Triplicate Test| % Positive
1.16 x 107| 3/3| 100%
1.16 x 106| 3/3| 100%
1.16 x 105| 3/3| 100%
1.16 x 104| 3/3| 100%
1.16 x 103| 3/3| 100%
1.16 x 102| 0/3| 0%

Study 2 – Pre-LoD testing
Based on the LoD screen data, the following dilutions of the SARS-CoV-2 were made in negative nasal matrix: 0.75X LoD, 1X LoD, 3X LoD, 5X LoD and 10X LoD. Each dilution was tested in triplicate with the Solana SARS-CoV-2 Assay.

Pre-LoD Results

SARS-CoV-2 Concentration (cp/mL)| # Positive/Triplicate Test| % Positive
1.16 x 104| 3/3| 100%
8.72 x 103| 3/3| 100%
3.48 x 103| 1/3| 33%
1.16 x 103| 1/3| 33%
8.72 x 102| 1/3| 33%

Study 3 –LoD Confirmation testing
Based on the Pre-LoD data, the dilution demonstrating ≥95% detection was used in the LoD confirmation study. A 1x LoD dilution was made in negative nasal matrix. This dilution was tested with twenty replicates with the Solana SARS- CoV-2 Assay.

LoD Confirmation

SARS-CoV-2 Concentration (cp/mL)| # Positive/Triplicate Test| % Positive
8.72 x 103| 16/20| 80%

Based on this data, the next highest LoD dilution was made in negative nasal matrix (1.16 x 104). This dilution was tested with twenty replicates with the Solana SARS-CoV-2 Assay.

LoD Confirmation

SARS-CoV-2 Concentration (cp/mL)| # Positive/Triplicate Test| % Positive
1.16 x 104| 20/20| 100%

The limit of detection (LoD) of the Solana SARS-CoV-2 Assay using limiting dilutions of heat-inactivated SARS-CoV-2 is 1.16 × 104 cp/mL. This LoD was confirmed by testing 20 replicates each of negative nasal matrix collected into the CDC Viral Transport Media spiked with heat-inactivated SARS-CoV-2 at 1.16 × 104 cp/mL.

ANALYTICAL REACTIVITY/INCLUSIVITY
Specific nucleic acid sequences used in the Solana SARS-CoV-2 Assay target the highly conserved regions of the SARS-CoV-2 virus non-structural Polyprotein (pp1ab).
The inclusivity of the Solana SARS-CoV-2 Assay was established through an in- silico analysis of available SARS-CoV-2 sequences. As of October 30, 2020, a total of 197,133 SARS-CoV-2 sequences were available from the GISAID and NCBI databases. Of these, 194,584 (98.71%) include the amplicon region (<5 Ns in any oligonucleotide region) and are 92.31-100% conserved to the Solana SARS- CoV-2 oligonucleotides.

CROSS-REACTIVITY (ANALYTICAL SPECIFICITY):
The Analytical Specificity of the assay was established by both direct testing of organisms in the assay (“wet” testing) and in-silico analysis. The potential microbial interference or cross-reactivity of Solana SARS-CoV-2 Assay was evaluated by testing various microorganisms (13), viruses (16) that may potentially interfere or cross-react based on the reasonable likelihood that they may be present in upper respiratory tract specimens. Each organism and virus was tested in negative nasal clinical matrix at target concentrations in the absence (negative) and presence (positive) SARS-CoV-2. Each condition (negative or positive) was tested with three replicates per substance. The final concentrations of the organisms and viruses are documented in the table below:

Cross-Reactivity/Microbial Interference Results|
---|---
Virus/Bacteria/Parasite| Strain| Source/ Sample type| Concentration| Cross-Reactivity Results| Interference Results
Adenovirus| Type 1| Isolate| 1 x 107.53 U/mL| No Cross-Reactivity| No Interference
Coronavirus| 229e| Isolate| 1 x 106.10 U/mL| No Cross-Reactivity| No Interference
Cross-Reactivity/Microbial Interference Results|
---|---
Virus/Bacteria/Parasite| Strain| Source/

Sample type

| Concentration| Cross-Reactivity

**Results***

| Interference

**Results***

Coronavirus| OC43| Isolate| 9.55 x 106

TCID50/mL

| No Cross-Reactivity| No Interference
Coronavirus| NL63| Isolate| 5 x 104.67 U/mL| No Cross-Reactivity| No Interference

MERS-CoV (heat-inactivated)

| Florida/USA- 2_Saudi

Arabia_2014

|

Isolate

| 1.17 x 106 TCID50/mL|

No Cross-Reactivity

|

No Interference

Mycoplasma pneumoniae| M129| Isolate| 3 x 107 CCU/mL| No Cross-Reactivity| No Interference
Streptococcus pyogenes| Z018| Isolate| 3.8 x 109 cfu/mL| No Cross- Reactivity| No Interference
Influenza A H3N2| Brisbane/10/07| Isolate| 1 x 105.07 U/mL| No Cross- Reactivity| No Interference
Influenza A H1N1| New

Caledonia/20/99

| Isolate| 1 x 106.66 U/mL| No Cross-Reactivity| No Interference
Influenza B| Brisbane/33/08| Isolate| 1 x 105.15 U/mL| No Cross-Reactivity| No Interference
Parainfluenza| Type 1| Isolate| 1 x 108.01 U/mL| No Cross-Reactivity| No Interference
Parainfluenza| Type 2| Isolate| 1 x 106.34 U/mL| No Cross-Reactivity| No Interference
Parainfluenza| Type 3| Isolate| 8.51×107

TCID50/mL

| No Cross-Reactivity| No Interference
Parainfluenza| Type 4b| Isolate| 1 x 107.53 U/mL| No Cross-Reactivity| No Interference
Enterovirus| Type 68| Isolate| 1 x 106.5 U/mL| No Cross-Reactivity| No Interference
Human Metapneumovirus| A1 (IA10-s003)| Isolate| 1 x 105.55 U/mL| No Cross- Reactivity| No Interference
Respiratory Syncytial Virus| Type A (3/2015

Isolate #3)

| Isolate| 1 x 105.62 U/mL| No Cross-Reactivity| No Interference
Human Rhinovirus| N/A| Inactivated

virus

| Not available| No Cross-Reactivity| No Interference
Chlamydophila pneumoniae| AR-39| Isolate| 2.9 x 107 IFU/mL| No Cross- Reactivity| No Interference
Haemophilus influenzae| Type b; Eagan| Isolate| 7.87 x 108 cfu/mL| No Cross-Reactivity| No Interference
Legionella pneumophila| Philadelphia| Isolate| 6.82 x 109 cfu/mL| No Cross-Reactivity| No Interference
Streptococcus pneumoniae| Z022; 19f| Isolate| 2.26 x 109 cfu/mL| No Cross- Reactivity| No Interference
Bordetella pertussis| A639| Isolate| 6.37 x 106 cfu/mL| No Cross- Reactivity| No Interference
Pneumocystis jirovecii-S.

cerevisiae Recombinant

| W303-Pji|

Isolate

| 1.56 x 108 cfu/mL| No Cross-Reactivity| No Interference
Mycobacterium tuberculosis| H37Ra-1| Isolate| 6.86 x 107 cfu/mL| No Cross- Reactivity| No Interference
Streptococcus salivarius| Z127| Isolate| 8.17 x 108 cfu/mL| No Cross- Reactivity| No Interference
Staphylococcus epidermidis| MRSE; RP62A| Isolate| 1.21 x 1010

cfu/mL

| No Cross-Reactivity| No Interference
Candida albicans| Z006| Isolate| 6.27 x 108 cfu/mL| No Cross-Reactivity| No Interference
Pseudomonas aeruginosa| Z139: VIM-1| Isolate| 7.48 x 108 cfu/mL| No Cross- Reactivity| No Interference

Coronavirus HKU1 was not tested for cross-reactivity due to lack of availability. 19 specimens containing Coronavirus HKU1 were tested and all resulted as negative, additional cross-reactivity wet testing was not required. Testing was performed in triplicate The Solana SARS-CoV-2 Assay primers were analyzed against 32 organisms for in silico cross-reactivity. All organisms except SARS-1 were <80% conserved to both primers..

INTERFERENCE SUBSTANCES STUDIES

A study was performed to demonstrate that potentially interfering substances that may be found in the upper respiratory tract do not cross-react or interfere with the detection of SARS-CoV-2 in the Solana SARS-CoV-2 Assay. Fourteen (14) potential interfering substances in the concentrations listed below were tested in the absence or presence of SARS-CoV-2. None of these substances demonstrated cross-reactivity or interference.

Cross-Reactivity/Interference Results

Interfering Substance| Active Ingredient| Concentration| Cross-Reactivity Results| Interference Results
Afrin – nasal spray| Oxymetazoline| 5%| No Cross-Reactivity| No Interference
Blood (human)| Blood| 5%| No Cross-Reactivity| No Interference
Chloraseptic, Cepacol| Benzocaine, Menthol| 0.7 g/mL| No Cross-Reactivity| No Interference
Flonase| Fluticasone| 5%| No Cross-Reactivity| No Interference
Halls Relief Cherry Flavor| Menthol| 0.8 g/mL| No Cross-Reactivity| No Interference
Nasocort Allergy 24 hour| Triamcinolone| 5%| No Cross-Reactivity| No Interference
Cross-Reactivity/Interference Results

Interfering Substance| Active Ingredient| Concentration| Cross-Reactivity

**Results***

| Interference

**Results***

Neo-Synephrine| Phenylephrine

hydrochloride

| 5%| No Cross-Reactivity| No Interference
Oseltamivir| Oseltamivir| 2.2 µg/mL| No Cross-Reactivity| No Interference
Purified mucin protein| Mucin protein| 2.5 mg/mL| No Cross-Reactivity| No Interference
Rhinocort| Budesonide

(Glucocorticoid)

| 5%| No Cross-Reactivity| No Interference
Saline nasal spray| Saline| 15%| No Cross-Reactivity| No Interference
Tobramycin| Tobramycin| 1.25 mg/mL| No Cross-Reactivity| No Interference
Zanamivir| Zanamivir| 282.0 ng/mL| No Cross-Reactivity| No Interference
Zicam Cold Remedy| Galphimia glauca, Luffa

operculata, Sabadilla

| 5%| No Cross-Reactivity| No Interference

CUSTOMER AND TECHNICAL SUPPORT

To place an order or for technical support, please contact a Quidel Representative at 800.874.1517 (toll-free in the U.S.) or 858.552.1100 (outside of U.S.), Monday through Friday, between 8:00 a.m. and 5:00 p.m., Eastern Time. Orders may also be placed by fax at 740.592.9820. For e-mail support contact: customerservice@quidel.com or technicalsupport@quidel.com. For services outside the U.S., please contact your local distributor. Additional information about Quidel, our products, and our distributors can be found on our website quidel.com. Test system problems may also be reported to the FDA through the MedWatch medical products reporting program (phone: 800.FDA.1088; fax: 800.FDA.0178; http://www.fda.gov/medwatch).

INTELLECTUAL PROPERTY
Dye compounds in this product are sold under license from Biosearch Technologies, Inc. and are protected by U.S. and worldwide patents either issued or under the application.

REFERENCES

1. https://www.who.int/publications/m/item/weekly-epidemiological-update—15-december-2020
2. Lauer, S.A., et. al. The incubation period of Coronavirus disease 2019 (COVID-19) from publicly reported confirmed cases: estimation and application, Ann Intern Med. 2020
3. www.cdc.gov/coronavirus/2019-ncov/about/symptoms.html
4. Clinical and Laboratory Standards Institute. Viral Culture; Approved Guidelines. CLSI document M41-A [ISBN 1562386239] Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2006.

References

• HHS Accessibility & Section 508 | HHS.gov
• English | QuidelOrtho
• quidel.com/glossary
• Weekly epidemiological update - 15 December 2020

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