GoldN GN005ST RSV Rapid Antigen Test Instructions

GoldN GN005ST RSV Rapid Antigen Test

Product Information

Specifications:

• Product Name: RSV Rapid Antigen Test (Nasal)
• Model: GN005ST
• Intended Use: Antigen Rapid Test for the detection of RSV in nasal swab
• For in vitro diagnostic use
• For Rx use only

Product Usage Instructions

Step 1 – Wash your hands:
After washing your hands, open the box, and check the components before use.

Step 2 – Read instructions for use:
Read instructions for use carefully before using the test.

Step 3 – Place the buffer tube into the holder and remove the foil seal:
Carefully place extraction tube into tube holder or tube stand.
Open the foil seal lid.

Step 4 – Take out the sterilized swab:
Pull open the swab packaging at the marked point and remove the swab. DO NOT TOUCH the soft head of swab.

Step 5 – Sample collection:
Tilt your head back slightly. Gently insert the swab about 2 cm into each nostril. Rotate the swab at least 5 times against the nasal wall.

Step 6 – Insert swab into tube:
Insert the sampled swab into the extraction buffer tube, rotate the swab tip along the inner wall, and squeeze to keep liquid in the bottle.

Step 7 – Remove swab from tube:
Remove the swab by gently squeezing the sides of the tube to release the liquid from the swab.

Step 8 – Close the dropper tube:
Put the dropper cap onto the tube and ensure it is sealed properly.

Step 9 – Take out the cassette:
Open the foil pouch and take out the test cassette. Place it on a flat and clean surface.

Frequently Asked Questions (FAQ):

1. Q: What should I do if I accidentally spill the extraction buffer liquid?
   A: If spilled, sterilize the area, and repeat the test using a new sampling swab and extraction solution tube.

2. Q: What if I feel discomfort during sample collection?
   A: If you feel discomfort, stop immediately. Do not insert the swab deeper if you feel strong resistance or pain.

RSV RAPID ANTIGEN TEST (Nasal)
REF: GN005ST
An Antigen Rapid Test for the detection RSV in nasal swab. For in vitro diagnostic use. For Rx use only.
Read the instructions carefully before taking the test.
Distributed by NOVODX Corporation 177 N US Highway 1, #309 Tequesta, FL 33469 USA
For more information email us at: info@novo-dx.com
Scan the QR code to watch “How to Use Video” and for more information on how to use the test.

QUICK REFERENCE GUIDE
For this test to work properly, read the instructions fully before starting the test and watch the instructional video (www.iamgoldn.com). For detailed instructions, refer to the instructions for use.

COLLECTION TIPS:

• Collect the sample as soon as possible after the onset of symptoms.
• Use only the swab provided.
• Follow the test procedure immediately after collecting the sample.
• Do not touch the tip (specimen collection area) of the swab.

POTENTIAL RISKS:

• Possible discomfort or other complications related to sample collection.

POTENTIAL BENEFITS:

• The results, along with other information, can help healthcare provider make informed recommendations about care.

HOW ACCURATE IS THE TEST?
The GoldN™ RSV Rapid Antigen Test was compared to a high-sensitivity RT-PCR test. The test can be performed accurately in a point-of-care setting with a 100.0% PPA and 100.0% NPA for RSV.

COMPONENTS PROVIDED

TEST PROCEDURE

STEP 1 – Wash your hands
After washing your hands, open the box, and check the components before use.

STEP 2 – Read instructions for use
Read instructions for use carefully before using the test.

STEP 3 – Place the buffer tube into the holder and remove the foil seal
Carefully place extraction tube into tube holder or tube stand.
Open the foil seal lid.

IMPORTANT
DO NOT DRINK the extraction buffer liquid. If accidentally consumed, immediately consult a healthcare professional.
DO NOT SPILL any of the extraction buffer liquid. If spilled, sterilize the area, and repeat the test using a new sampling swab and extraction solution tube.
STEP 4 – Take out the sterilized swab
Pull open the swab packaging at the marked point and remove the swab.

DO NOT TOUCH the soft head of swab.
DO NOT OPEN the swab until you are going to use it immediately.
STEP 5 – Sample collection
Tilt your head back slightly. Gently insert the swab about 2 cm into the left nostril. At least with the entire soft portion of the swab. Gently rotate the swab at least 5 times against the nasal wall. Do the same for the right nostril. Gently rotate the swab at least 5 times against the nasal wall. Remove the swab from the second nostril.

IMPORTANT
IF YOU FEEL DISCOMFORT, STOP IMMEDIATELY.
If the swab stick breaks during the sample collection, please use a new swab. Do not insert the swab deeper if you feel strong resistance or pain.
STEP 6 – Insert swab into tube
Remove foil seal.
Insert the sampled swab into the extraction buffer tube and dip the tip into the tube. Rotate the swab tip 10 times along the inner wall of the buffer tube and squeeze the
tip of the swab 5 times along the inner wall of the tube to keep as much liquid in the bottle as possible.

STEP 7 – Remove swab from tube
Remove the swab from the tube by gently squeezing the sides of the tube to release the liquid from the swab.

IMPORTANT
If squeezing the tube is not done correctly, sample swab absorbs much more liquid from the extraction buffer and that will yield wrong results.
STEP 8 – Close the dropper tube
Put the dropper cap onto the sample extraction solution tube and press until closed.

IMPORTANT
Ensure the lid is sealed properly.
Do not spill any of the sample extraction liquid.
STEP 9 – Take out the cassette
Open the foil pouch and take out the test cassette.
Place it on a flat and clean surface.

IMPORTANT
Perform the test within 15 minutes after the foil pouch is opened.
STEP 10 – Test Operation Add 3 drops of the extraction buffer tube to the sample well on the test cassette.

IMPORTANT
Ensure to add at least 3 drops of the liquid from the specimen tube into each sample well. If less than 3 drops, that will yield wrong results.
STEP 11 – Test Operation Set timer and wait for 15 minutes.

IMPORTANT
DO NOT READ the result beforehand or after 20 minutes, even if a line has already appeared at the region “C”.
STEP 12 – Read your results
To read your test results, please see the interpretation of the results section provided below.
STEP 13 – Disposal
Please dispose all parts of the test kits and place them in the biohazard bag that it can be disposed in the hazard waste or rubbish bin. If there are local regulations, please follow them.
STEP 14 – Wash your hands
Wash your hands thoroughly after test completion.

TEST OPERATION

+POSITIVE RESULTS
THE SHADE OF LINES MAY VARY, BUT EVEN IF A FAINT/ WEAK LINE APPEARS, IT SHOULD BE CONSIDERED POSITIVE.
If you have a POSITIVE result, follow the guidance from your local, state or territory Health Department for guidance on confirmation testing, if necessary.
If unwell, seek medical assistance from a qualified medical practitioner for follow up care for RSV, depending on diagnostic testing results.

– NEGATIVE RESULTS
ONLY RED LINES APPEAR IN THE CONTROL REGIONS (C), AND NO LINE IN THE REGION (T). The negative result indicates that there are no RSV particles in the sample or the number of viral particles is below the detectable range. Even if you get a negative result, you still need to follow all public health advice on limiting the spread of RSV.
If symptoms persist, repeat testing and consult a medical practitioner for follow-up clinical care.

? INVALID RESULTS
NO RED LINE APPEARS IN THE CONTROL REGION (C) FOR RSV. The test is invalid even if there is a line on the region (T).
WHEN NO RED LINE APPEARS IN THE CONTROL REGION (C) THE TEST IS INVALID. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line (C) failure. Review the test procedure and repeat the test using a new test device. If invalid results continue after repeating, please contact NOVODX Corporation on the provided email for assistance.

GOLDN™ RSV RAPID ANTIGEN TEST KIT
Reference Number: GN005ST
A Rapid Antigen Test for the detection of RSV in nasal swab.
In vitro diagnostic device for Rx use only.

INSTRUCTIONS FOR USE
INTENDED USE
The GoldN™ RSV Rapid Antigen Test Kit is an in vitro immunochromatographic assay for the qualitative detection of antigens in nasal swab specimens collected by healthcare professionals against the respiratory infection for Respiratory Syncytial Virus (RSV), within the first 4 days of the onset of symptoms. This test is intended for use as an aid in the diagnosis of RSV viral infections in humans in conjunction with clinical and epidemiological risk factors. The test does not require any special training for sample collection, processing, or test operation. The test can be performed by healthcare profesionals on patients ages 2 and above. This kit is not suitable for children under 2 years old. This test is intended for use in individuals with or without symptoms or other epidemiological reasons to suspect a respritory infection. The GoldN™ RSV Rapid Antigen Test Kit is inteded for prescription and professional use only.

SUMMARY AND EXPLANATION
Respiratory Syncytial Virus is a single-stranded (negative strand) RNA virus of the Paramyxoviridae family. It is the causative agent of a highly contagious, acute, viral infection of the respiratory tract. Nearly half of all children become infected within their first year of life. It is also the major viral cause of nosocomial illness in children already hospitalized for other reasons. Viral respiratory tract infections are responsible for widespread disease. Respiratory syncytial virus is a leading cause of lower respiratory tract infections (LRI) in young children in both the developed and developing worlds. Worldwide, it is estimated that RSV is responsible for greater than 30 million cases of LRI in children under 5 years of age each year. Diagnostic methods for detection of respiratory viruses include viral cell culture, direct fluorescent antibody (DFA), rapid immunoassays, and nucleic acid amplification assays such as the polymerase chain reaction (PCR). Each has been demonstrated to have clinical utility for the detection of respiratory viruses including RSV.

PRINCIPLE OF THE TEST
The GoldN™ RSV Rapid Antigen Test Kit is an immunochromatographic membrane assay which detects the RSV antigen. In the test procedure, a specimen is collected by nasal swab; the nasal swab requires a sample preparation step in which the sample is eluted from the swab into a buffer solution. Three drops of the resulting solution is applied to the sample well to migrate through the pads containing highly sensitive detector antibodies conjugated to gold dye for detection of nucleocapsid antigens. When the swab/buffer sample migrates into the test strip the gold nanoparticles labeled anti-RSV will bind the viral antigens to form an antibody-antigen immune complex. The immune complex is then captured by the test line on the nitrocellulose membrane as it migrates through the strip. Test results are to be interpreted in the time window between 15 and 20 minutes. The presence of colored lines, at both the test and control line, indicates a positive sample. The presence of one red colored line indicates a negative or invalid test.

MATERIALS PROVIDED WITH THE TEST KITS

(1 test/pouch x 25 pouches)
Extraction Buffer Tube (with dropper)| 1 single-use bottle, each with 500 μL extraction buffer| 2 single-use bottles, each with 500 μL extraction buffers| 5 single-use bottles, each with 500 μL extraction buffers| 25 single- use bottles, each with 500 μL extraction buffers
Sterilized Swab| 1 sterile, single use swab| 2 sterile, single use swabs| 5 sterile, single use swabs| 25 sterile, single use swabs
Instruction For Use| 1 instruction for use| 1 instruction for use| 1 instruction for use| 1 instruction for use

STORAGE AND STABILITY

1. Store the test kit at 2-30°C. DO NOT FREEZE and DO NOT STORE the test kit in direct sunlight. All components must be brought to room temperature before testing.
2. The test cassette must be used within 15 minutes after removal from the foil pouch.
3. DO NOT USE after the expiry date. The expiry date is stated on the label/packaging.

LIMITATION

• Failure to follow the instructions for use may adversely affect test performance and/or invalidate the test results.
• Results from antigen testing should not be used as the sole basis to diagnose or exclude RSV infection or to determine infection status.
• This test will indicate the presence of RSV nucleocapsid protein antigen in the specimen from both viable and non-viable virus. Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample.
• The detection of RSV nucleocapsid antigen is dependent upon proper specimen collection, handling, storage, and preparation. Failure to observe proper procedures in any one of these steps can lead to incorrect results.
• Results from the device should be correlated with the clinical history, epidemiological data and other data available.
• This device has been evaluated for use with human specimen material only.
• False-negative results may occur if the concentration of the target antigen in the clinical specimen is below the detection limits of the device.
• This test cannot rule out diseases caused by other bacterial or viral pathogens.
• Each test can only be used once.
• Test results must be read at 15 minutes and no later than 20 minutes.
• A negative result does not mean a person is not infectious or does not have RSV. If symptoms persist the person should seek medical attention and further testing if required.
• Positive test results do not rule out bacterial infection or co-infection with other viruses.
• The test is less reliable in the later phase of infection and in asymptomatic individuals.
• Children aged 2-18 years old should have the samples collected and tested by an adult. Not intended for use on children under 2 years of age.

QUALITY CONTROL
A colored line in the control area (C) is considered an internal process control. It confirms complete penetration of the membrane with the sample, reactivity of the reagents, and correct test performance.

PERFORMANCE CHARACTERISTICS

Clinical Study Performance
The human usability and clinical evaluation of the NOVODX GoldN™ RSV Rapid Antigen Test Kit was evaluated by in comparison with an RT-PCR assay. Samples were taken within 7 days of symptom onset.
The performance of the GoldNTM RSV Rapid Test Kit was assessed using 345 nasopharyngeal swabs from patients. Symptomatic subjects were defined as those exhibiting at least one of the following signs and symptoms on the day of presentation: fever, cough, body aches, sore throat, chills, congestion, or runny nose. Asymptomatic subjects were defined as subjects not experiencing symptoms on the day of testing. Testing was administered by laboratory professionals trained on the test procedure, following the steps of the IFU (www.iamgoldn.com). A nasal swab sample was also collected by a healthcare provider for testing using a US FDA authorized highly sensitive RT-PCR test. Swabs for the GoldN™ RSV Rapid Antigen Test Kit and comparator test were collected in a randomized manner to prevent bias in viral load.
Results from this study demonstrated that the GoldN™ RSV Rapid Antigen Test Kit can be performed accurately for RSV with a 100.0% PPA and 100.0% NPA. The following table summarizes the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for the GoldN™ RSV Rapid Antigen Test Kit when compared with an FDA high sensitivity assay.
Performance of the GoldN™ RSV Rapid Antigen Test Kit as compared to a high sensitivity molecular RSV assay in ALL subjects.

ANALYTICAL PERFORMANCE
Limit of Detection (LOD) The minimum detection limit of the GoldN™ RSV Test Kit for RSV, the detection limit is 240 TCID50/mL.

VARIANTS
Respiratory Syncytial Virus (RSV) Variants RSV A and RSV B.

ANALYTICAL SPECIFICITY
Cross Reactivity The cross-reactivity of the kit was evaluated. The results showed no cross-reactivity with the following samples: Adenovirus Type 3, Adenovirus Type 5, Adenovirus Type 7, Human Parainfluenza Type 1, Human Parainfluenza Type 2, Human Parainfluenza Type 3, Human Parainfluenza Type 4, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus 229E, Respiratory syncytial virus Type A, Respiratory syncytial virus Type B, Rhinovirus Type 1, Rhinovirus Type 14, Rhinovirus B70, Enterovirus CA16, Enterovirus 70, Human para-flu virus Type 1, Human para-flu virus Type 2, Human para-flu virus Type 3, Human para-flu virus Type 4, Cytomegalovirus, Measles virus, Boca virus, Mumps virus, Epstein Barr Virus, Herpes simplex virus (HSV-1), Varicella-zoster virus, Human metapneumovirus, MERS coronavirus, SARS-coronavirus, Human coronavirus (HKU1), Bordetella pertussis, Bordetella parapertussia, Staphylococcus epidermidis, Staphylococcus aureus, Staphylococcus pneumoniae, Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus salivarus, Escherichia coli, Candida albicans, Mycobacterium tuberculosis, Paramyxovirus parotitis, Pneumocystis jirovecii, Moraxella catarrhalis, Pseudomonas aeruginosa, Pneumocystis, Legionella pneumophila, Corynebacterium pneumophila, Lactobacillus pneumophila, Klebsiella pneumoniae, Mycoplasma pneumoniae, Chlamydia pneumoniae, Neisseria pneumophila, Neisseria meningitides, Haemophilus influenza.

Interference Substances The test results are not interfered with by the substances in the tabulated concentrations:

PRECAUTIONS

1. For in vitro diagnostic use only.
2. Do not use the kit contents beyond the expiration date printed on the outside of the box.
3. Do not reuse the used test card, reagent tube or swab.
4. The aluminum pouch includes a test cassette and a silica gel dissicant. Silica gel is required for protecting the test cassette against environmental conditions. Do not use the test kit if the aluminum pouch does not include silica gel. Do not swallow the silica gel. If swallowed, immediately consult a healthcare professional.
5. All users must read the instructions for use carefully before carrying out the test.
6. The sample buffer and test cassette must be brought to room temperature (18-30°C) before use, otherwise the results may be false.
7. Discard and do not use any damaged or dropped test cassette or material.
8. Users should test specimens as soon as possible after collection if the sample is not stored in sample extraction solution.
9. Do not spill any of the sample extraction solution. If spilled, sterilize the area and if the amount of the sample extraction solution mixture is not enough to perform the test, repeat the test by using new sampling swab and extraction solution tube.
10. Do not drink the extraction solution in the tube with or without swab. Immediately consult your healthcare professional if consumed
11. If the sample volume is insufficient, the assay will not perform successfully.
12. The Buffer Solution contains a salt solution (saline). If the solution contacts the skin or eye, flush with copious amounts of water.
13. Inadequate or inappropriate storage and transport of all components and sample collection may yield false test results.
14. To obtain accurate results, do not use visually bloody or overly viscous specimens.
15. To obtain accurate results, an opened and exposed Test Card should not be used in a heavily ventilated or moist area.
16. Wash hands thoroughly after handling.
17. Do not touch the sample well or the membrane of the test cassette.
18. Keep out of reach of children.

NEED HELP WITH THE TEST?
Before You Start
Do not open the foil pouch and swab packaging until you have read the instructions and are ready to take the test.
Use immediately upon opening.

Will this test hurt?
No, the nasal swab is not sharp, and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from a medical professional.

When should I perform the test after opening the foil pouch?
You should perform the test within 15 minutes after opening the foil pouch.

How long can I keep the swab out without using?
Do not open the swab packaging until you are going to use it immediately.

What do you need to consider when storing the test kit?
You can store the test kit at a temperature between 2-30°C.
Do not freeze and do not store the test kit in direct sunlight. All components must be bought to room temperature before testing. Do not use after expiry date.

Sample Collection
Do I need to insert the swab into both of my nostrils to take sample?
Yes, you must take the samples from from both your nostrils.

How deep should I insert the swab into my nostrils?
Gently insert the swab about 2cm (soft head of the swab) into your nostrils. Do not insert the swab deeper if you feel strong resistance or pain.

Test Operation
How many drops should I add in both sample wells?
Add 3 drops using the buffer tube dropper into the sample well on the cassette.

How long should I wait to read my results?
Make sure you wait at least 15 minutes, and then read your results at 15-20 minutes.

Read Results
How do I know if the test was run properly?
A colored line will appear in the control region (C) of the test cassette if the test has been properly performed. If this line is not visible, then the test has been incorrectly performed and you must run a new test.

If there is a faint/weak line appearing at T, should the results still be considered as positive?
Yes, even if there is a faint line at the region T, the results must be considered as positive.
Results are only valid on the test if the control line (C) present.

Don’t know how deep I should insert the swab into my nostrils?
Gently insert the swab about 2 cm (soft head of the swab) into your nostrils. Do not insert the swab deeper if you feel strong resistance or pain.

TEST PROCEDURE

Read the instructions carefully before taking the test.

STEP 1 – Wash your hands
Wash or clean your hands and make sure they are dry before starting the test. After washing your hands, open the box, and check the components before use.

STEP 2 – Read Instructions for use
Read instructions for use carefully before using the test.

STEP 3 – Place the buffer tube into the holder
Carefully place extraction tube into tube holder or tube stand. Open the foil seal lid.
DO NOT DRINK the extraction buffer liquid. If you accidentally drink it immediately consult your healthcare professionals. DO NOT SPILL any of the extraction buffer liquid. If you spill it, sterilize the area, and repeat the test by using a new sampling swab and extraction solution tube.

STEP 4 – Open the sterilized swab
Pull open the swab packaging at the marked point and remove the swab.
DO NOT TOUCH soft head of swab. DO NOT OPEN the swab until you are going to use it immediately.

STEP 5 – Sample Collection
Tilt your head back slightly. Gently insert the swab about 2cm into the left nostril. At least with the entire soft swab. Gently rotate the swab at least 5 times against the nasal wall. Do the same for the right nostril. Gently insert the swab about 2cm. At least with the entire soft swab. Gently rotate the swab at least 5 times against the nasal wall. Remove the swab from the second nostril. IF YOU FEEL DISCOMFORT, STOP IMMEDIATELY. If the swab stick breaks during the sample collection, please use a new swab. Do not insert the swab deeper if you feel strong resistance or pain.

STEP 6 – Insert swab into tube
Remove the foil seal on buffer tube.
Insert the sampled swab into the extraction buffer tube and dip the tip into the tube. Rotate the swab tip 10 times along the inner wall of the buffer tube. And squeeze the tip of the swab 5 times along the inner wall of the tube to keep as much liquid in the bottle as possible.

STEP 7 – Remove swab from tube
Remove the swab from the tube by squeezing the sides of the tube to release the liquid from the swab.
If squeezing of tube is not done correctly, sample swab absorbs much more liquid from the extraction buffer and that will yield wrong results. Discard the swab in the biohazard specimen bag.

STEP 8 – Close the tube
Seal the lid on the extraction tube with the affixed dropper.

STEP 9 – Take out the cassette
Open the foil pouch and take out the test cassette. Place it on a flat and clean surface. Perform the test within 15 minutes after the foil pouch is opened.

STEP 10 – Test operation
Add 3 drops of the extraction buffer tube to the sample well.
Ensure to add at least 3 drops of the liquid from the specimen tube into the sample well. If adding less than 3 drops, that may yield incorrect results.

STEP 11 – Wait for result
Set timer and wait for 15 minutes. Read the result at 15-20 minutes. DO NOT READ the result beforehand or after 20 minutes, even if a line has already appeared at the region “C”.

STEP 12 – Read your results
To read your test results, please go to the interpretation of the results section provided below.

STEP 13 – Disposal
Please dispose all parts of the test kits and place them in the biohazard bag that can be disposed of in the household waste or rubbish bin. If there are local regulations, please follow them.

STEP 14 – Wash your hands
Wash your hands thoroughly after test completion.

INTERPRETATION OF THE RESULTS
TEST WINDOW FOR RSV MUST BE READ INDEPENDENTLY FROM 15-20 MIN AFTER FIRST TEST.

POSITIVE RESULTS
THE SHADE OF LINES MAY VARY, BUT EVEN IF A FAINT/WEAK LINE APPEARS, IT SHOULD BE CONSIDERED POSITIVE. If you have a POSITIVE result, follow the guidance from your local, state or Territory Health Department for guidance on confirmation testing, if necessary. If unwell, seek medical assistance from a qualified medical practitioner for RSV, depending on diagnostic testing results.
NOTE: You do not need to perform repeat testing if you have a positive result at any time.

NEGATIVE RESULTS
ONLY RED LINES APPEAR IN THE CONTROL REGIONS (C), AND NO LINE IN THE REGION (T).
The negative result indicates that there are no RSV particles in the sample, or the number of viral particles is below the detectable range. Even if you get a negative result, you still need to follow all public health advice on limiting the spread RSV. If symptoms persist, repeat testing, and consult a medical practitioner for follow-up clinical care.
NOTE: To increase the chance that the negative result for RSV is accurate, you should:

• Test again in 48 hours if the individual has symptoms on the first day of testing.
• Test 2 more times at least 48 hours apart if the individual does not have symptoms on the first day of testing.

NOTE: A negative result is presumptive, meaning it is not certain that you do not have RSV. You may still have RSV and you may still be contagious. There is a higher chance of false negative results with antigen tests compared to laboratory-based tests such as PCR. If all repeat tests are negative and you are concerned you have RSV, you may choose to test again using an antigen test or consult with your health care provider regarding molecular testing.

INVALID RESULTS
NO RED LINE APPEARS IN THE CONTROL REGION (C) FOR RSV. The test is invalid even if there is a line on the region (T).
INVALID: WHEN NO RED LINE APPEARS IN THE CONTROL REGION (C) If the test is invalid, a new test should be performed with a new sample collection. Repeat testing is needed to improve test accuracy. Problems could be caused by insufficient sample volume or incorrect procedural techniques. These are the most likely reasons for control line (C) failure. Review the test procedure and repeat the test using a new test device. If invalid result continues after repeating, please contact NOVODX by the provided email for assistance.

INTERPRETATION OF THE RESULTS
Results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with RSV. A negative result is presumptive, meaning it is not certain that you do not have RSV. You may still have other respritory infections. There is a higher chance of false negative results with antigen tests compared to laboratory-based tests such as PCR. Persons who test positive with the NOVODX GoldN™ RSV Rapid Antigen Test Kit should seek follow-up care with their physician or healthcare provider as additional testing and public health reporting may be necessary. Positive results do not rule out bacterial infection or co-infection with other viruses. Persons who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have an infection and should seek follow-up care with their physician or healthcare provider. If you receive a negative test but still are symptomatic or feel unwell, seek follow-up care with your physician or healthcare provider.

BIBLIOGRAPHY

1. http://www.cdc.gov/RSV/index.html. Accessed on March 14, 2013.
2. Acero-Bedoya, S., Wozniak, P. S., Sánchez, P. J., Ramilo, O., & Mejias, A. (2019). Recent trends in RSV immunoprophylaxis: clinical implications for the infant. American journal of perinatology, 36(S 02), S63-S67.

| Materials Included| | Keep away from sunlight| | Date of Manufacture
---|---|---|---|---|---
| Test Card| | In Vitro Diagnostic Device| | Do Not Reuse
| Consult Instructions for Use| | Store at 40-60% humidity| | Reference Number
| Store at 2-30ºC| | Tube| | Tests per Kit
| Keep Dry| | Instruction for Use| | Do not use if the package is damaged
| Lot Number| | Expiration Date| | Swab
| Sample Diluent| | Manufacturer| Rx ONLY| Perscription use only
| Distributor|

REF : GN005ST
Corresponds to NOVODX Catalog #s: GN005PC01 (1 Pack), GN005PC02 (2 Pack), GN005PC05 ( 5 Pack), GN005PC25 (25 Pack).

Vitrosens Biyoteknoloji Ltd. Sti.
Address: Serifali Mh., Sehit S. No:17, 34775 Ümraniye/istanbul/Turkey

LIT-IFU-GN005PC-US-EN (RXonly) RSV (DOC-507) Ver. 0
Approved By:
(CO-78) GN005ST Initial IFU launch
Description
Initial launch of IFU for RSV Rapid test

Justification
New product launch
Assigned To: Thomas Kempton
Initiated By: Andrew Hall
Priority: Medium
Impact: Major

Version History:
Author
Andrew Hall

Effective Date
April 2, 2024 4:28 PM EDT

CO#
CO-78

Ver.
0

Status
Published

References

• dx.com
• Respiratory Syncytial Virus (RSV) | RSV | CDC
• Are you GoldN

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