• Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
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  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab

Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab

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Effective detects multiple covid variants, including Delta and Omicron
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  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Melifluo MF81 Sars-CoV-2 Antigen Rapid Test - 2 in 1 Saliva • Nasal Swab
  • Description
•  Convenient and easy to use,  2 in 1 Saliva or Nasal Swab  design makes it easy to use and quickly get rapid results in 5 to 15 minutes; 
•  Reliable Quality with Highly Accurate, this test detects the antigen protein of all known major COVID-19 variants (including Delta and Omicron). The test works for both symptomatic and asymptomatic individuals.
•  For age 2 and Above: The self-administered test is recommended for individuals aged 15 years and older. Adult-collection is required for testing children 2-14 years old. 


INTENDED USE
The Melifluo Sars-CoV-2 Antigen Rapid Test is lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab and saliva specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is intended to be used by professionals and non-prescription home use directly from individuals aged 14 years and older or with adult-collected samples directly from individuals aged 2 years or older. The Melifluo Sars-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2.
 
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. This antigen is generally detectable in anterior nasal swabs and saliva during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine 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.
 
Individuals who test positive at home should self-isolate and consult their doctor as additional testing may be necessary and for public health reporting.
 
Negative results are presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.
 
Individuals use at home should provide all results obtained with this product to their doctor or healthcare provider for public health reporting. Doctors or healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities.


SUMMARY
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

PRINCIPLE
The Melifluo Sars-CoV-2 Antigen Rapid Test Kits is a lateral flow chromatographic immunoassay. The test strip in the cassette consists of 1) a burgundy-colored conjugate pad containing mouse anti-novel coronavirus nucleoprotein monoclonal antibody conjugated with colloidal gold and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing one test lines (T lines) and a control line (C line). The T line is pre-coated with antibodies for the detection of novel coronavirus nucleoprotein antigen, and the C line is pre-coated with a control line antibody. 
 
When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action along the cassette. Novel coronavirus nucleoprotein antigen, if present in the specimen, will bind to the mouse anti-novel coronavirus nucleoprotein antigen conjugates.

he immunocomplex is then captured by the pre-coated mouse anti-novel coronavirus nucleoprotein monoclonal antibody, forming a burgundy-colored T line, indicating a novel coronavirus positive test result and suggesting an infection with novel coronavirus. 
 
Absence of T lines suggests a negative result. Each test contains an internal control (C line) which should exhibit a burgundy-colored line of the control antibodies regardless of color development on any of the test lines. If the C line does not develop, the test result is invalid, and the specimen must be retested with another device.
 

WARNINGS AND PRECAUTIONS

For in Vitro Diagnostic Use
1. For healthcare professionals and individuals home use.
2. Do not use this product as the sole basis to diagnose or exclude.
3. SARS-CoV-2 infection or to inform infection status of COVID-19.
4. Do not use after the expiration date.
5. Please read all the information in this leaflet before performing the test.
6. The test cassette should remain in the sealed pouch until use.
7. All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
8. The used test cassette should be discarded according to federal, state and local regulations.                          

  
MATERIALS
 Materials Provided:
 
Kit Component MF81-1T MF81-2T MF81-5T MF81-25T
Test Cassette 1 2 5 25
ExtractionBuffer (350μL/buffer vial) 1 2 5 25
Disposable Sampling Nasal Swab 1 2 5 25
Disposable Sampling Bag (for Saliva use) 1 2 5 25
Disposable Sampling Pipette (for Saliva use) 1 2 5 25
BiohazardSpecimen (Waste) Bag 1 2 5 25
Instruction forUse 1 1 1 1
 
Materials required but not provided: Timer

STORAGE AND STABILITY
The stability of the device is unknown at the time of writing. We recommend storing the rapid tests between 2-30°C (36-86°F). Do not freeze. Do not use beyond the expiration date.

NASAL SWAB SPECIMEN COLLECTION AND HANDLING PROCEDURES:

1. Remove the foil from the top of the extraction buffer tube. 

2.Punch through the perforated circle on the kit box  ( For 25 tests/box, tube holder is included.), place the tube in the tube holder.
3.  Swab specimen collection: Gently rotate and push into one side of the nasal cavity, press the swab on the nasal wall five times, then take it out. Repeat the process again at the other side of the nasal cavity.
 


4. Insert the swab sample into the buffer tube. Roll the swab at least 6 times while pressing the head against the bottom side of the extraction tube. Leave the swab in the extraction tube for one minute. Note: A false negative result may occur if the swab is not swirled at least 1 minute or rotated 6 times.
5. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. Attach the dropper tip onto the extraction tube tightly. Mix thoroughly by swirling or flicking the bottom of the tube. The mixed sample solution will be used as test specimen sample.
 


SALIVA SPECIMEN COLLECTION AND HANDLING PROCEDURES:
DO NOT place anything in the mouth including food, drink, gum, or tobacco products for at least 30 minutes prior to collection.
 
1.  Remove the foil from the top of the extraction buffer tube.
2. Punch through the perforated circle on the kit box  ( For 25 tests/box, tube holder is included.), place the tube in the tube holder.
 3.  Take out the saliva sample bag from the test kit. Spit into the bag 2-3 times sputum better, and use the pipette provided to take approximately 0.3 ml saliva sample as the image illustrated below.

4. Squeeze the pipette bulb and add 2 drops of saliva/sputum sample into the buffer tube. Remove the pipette and cover the tube with the dropper tip. Shake the sample tube more than three times vigorously to mix the saliva and the extraction reagent, then squeeze the mixed solution ten times to allow the saliva to be thoroughly mixed.  
TEST PROCEDURES
  1. Take the test cassette from the packaging bag and place it on a table. 
  1. Reverse the extraction tube, holding the tube upright, and transfer 3 drops (approximately 100μL) to the specimen well(S) of the test cassette, then start the timer. 
  2. Wait for colored lines to appear. Read the result in 5 to 15 minutes. The result is considered inaccurate and invalid after 20 minutes.

                
INTERPRETATION OF RESULTS

POSITIVE RESULT:

Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T). NEGATIVE RESULT:
Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).

INVALID RESULT:

Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
 

QUALITY CONTROL

1.       Internal Control: This test contains a built-in control feature, the C line. The C line develops after adding specimen and sample diluent. If there is no visible C line, review the whole procedure and repeat the test using a new device.
2.       External Control: Good Laboratory Practice recommends using the external controls, positive and negative, to assure the proper performance of the assay, particularly under the following circumstances:
a)        A new operator uses the kit, prior to performing testing of specimens.
b)        A new lot of test kit is used.
c)        A new shipment of kits is used.
d)        The temperature during storage of the kit falls outside of 2-30.
e)        The temperature of the test area falls outside of 15-30.
f)         To verify a higher-than-expected frequency of positive or negative results.

PERFORMANCE CHARACTERISTICS
Clinical Performance on the Point of Care Testing of Melifluo Sars-CoV-2 Antigen Rapid Test 
The Melifluo Sars-CoV-2 Antigen Rapid Test has been evaluated with specimens obtained from patients. A commercialized molecular assay was used as the reference method. · The results show that the Melifluo Sars-CoV-2 Antigen Rapid Test has a high overall relative accuracy.

Melifluo Sars-CoV-2 Antigen Rapid Test Cassette

RT-PCR

Positive

Negative

Total

Positive

64

0

64

Negative

1

227

228

Total

65

227

292

Positive Percent Agreement (PPA)

98.5% (95% CI: 93% - 99.8%)

Negative Percent Agreement (NPA)

100% (95% CI: 98% - 100%)

Positive Percent Agreement (PPA)= 64/65 (98.5%) (95%CI: 93% - 99.8%) 
Negative Percent Agreement: (NPA) = 108/ 108(99.68%) (95%CI: 98% - 100%) 
Accuracy= (64+227)/292×100%= 99.66%
Kappa= 2×27169/284034= 0.940.5
Assay Cross Reactivity
The potential cross reactivity(exclusivity] of a panel of common organisms was evaluated with SARS-COV-2 negative samples using the Melifluo Sars-CoV-2 Antigen Rapid Test Potential microbial interference was evaluated withsamples containing heat-inactivated SARS-COV-2 isolate Hong Kong/M20001061/2020 at approximately 3x LOD.4.1. A total of twenty-five (25) potential cross-reactant samples were evaluated for cross-reactivity at predefined concentrations in accordance with the EUA guidelines Antigen Template for Test Developers (version October 26, 2020) No cross-reactivity was observed with the Melifluo Sars-CoV-2 Antigen Rapid Test.
Viral Pathogens 0acterialPathogces
Coronavirus OCN43 [Culture Fluid) Mycoplasma pneumoniae
Coronavirus 229E (Heat inactivated) Bordetella pertussis
Coronavirus NL63(Heat inactivated) Candida albicans
Parainfluenza Virus Type3 (Culture Fluid) Streptococcus pyogenes
Parainfluenza Virus Type2 (Culture Fluid) Streptococcus pneumoniae
Parainfluenza Virus Tye 1  (Culture Fluid) Hemophilus influenza
Human Metapneumovirus 16(Culture Fluid) Legionella pneumonia
Adenovirus (Culture Fluid) Staphylococcus epidermidis
Parainfluenza Virus Type 4A (Culture Fluid) Staphylococcus aureus
lnfluenza A H1N1 Virus (Culture Fluid) Nasal Wash
lnfluenza B virus  (Culture Fluid) Chlamydophila pneumoniae
Enterovirus Type 68 (Culture Fluid)  
Respiratory Syncytial Virus Type A (Culture Fluid)  
MERS CoV (Culture Fluid, Heat Inactivated)  
Coronavirus OCN43 (Culture Fluid)  
Coronavirus 229E (Heat inactivated)  

Interfering Substances
Common substances (such as pain and fever medication and blood components) may affect the performance of The Melifluo Sars-CoV-2 Antigen Rapid Test Cassette. This was studied by spiking these substances into The Melifluo Sars-CoV-2 Antigen Rapid Test negative and positive, respectively. The results demonstrate that at the concentrations tested, the substances studied do not affect the performance of The Melifluo Sars-CoV-2 Antigen Rapid Test Cassette.
List of potentially interfering substances and concentrations tested:
 
Potential Interfering Substances Concentration Potential Interfering Substances Concentration
Whole Blood 4% Zicam 5% v/v
Mucin 0.50% Homeopathic (Alkalol) 1:1 dilution
Chloraseptic (Menthol/Benzocaine) 1.5mg/mL Sore Throat Phenol Spray 15% v/v
NasoGEL (NeiMed) 5% v/v Tobramycin 4μg/mL
CVS Nasal Drops (Phenylephirne) 15% v/v Mupirocin 10mg/mL
Afrin (Oxymetazoline) 15% v/v Fluticasone Propionate 5% v/v
CVS Nasal Spray(Cromolyn) 15% v/v Tamiflu(Oseltamivir Phosphate) 5mg/mL


 LIMITATIONS

  1. The contents of this kit are to be used for the qualitative detection of SARS antigens from nasal swab and nasopharyngeal swab.
  2. This test detects both viable (live) and non-viable, SARS-CoV, and SARS-CoV-2. 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.
  3. A negative test result may occur if the level of antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly.
  4. Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result.
  5. Test results must be evaluated in conjunction with other clinical data available to the physician.
  6. Positive test results do not rule out co-infections with other pathogens.
  7. Positive test results do not differentiate between SARS-CoV and SARS-CoV-2.
  8. Negative test results are not intended to rule in other non-SARS viral or bacterial infections.
  9. Negative results should be treated as presumptive and confirmed with an FDA authorized molecular assay, if necessary, for clinical management, including infection control.
  10. Clinical performance was evaluated with frozen samples, and performance may be different with fresh samples.
  11. Specimen stability recommendations are based upon stability data from influenza testing and performance may be different with SARS-CoV-2. Users should test specimens as quickly as possible after specimen collection.
  12. If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with state or local public health departments, is required.
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