Product Details
Rapid Test Kit SARS-CoV-2 Antigen With Influenza A/B Rapid Test Kit
Combo Test Simple To Use Rapid Test Kit
Intended Use
- The SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit is a
lateral flow chromatography immunoassay intended for the
qualitative detection and differentiation of nucleocapsid protein
antigens from SARS-CoV-2, influenza type A and influenza type B in
the same time directly from nasal/nasopharyngeal (NS/NP) swab,
oropharyngeal (OP) swab and saliva specimens from patients with
signs and symptoms of respiratory viral infection.
- For prescription use only.
- For in vitro diagnostic use only.
Specification
Item | Antigen test strip performance against PCR | Influenza A test strip performance against PCR | Influenza B test strip performance against PCR |
Sensitivity | 98.03% | 93.3% | 97.00% |
Specificity | 100.00% | 91.00% | 96.40% |
Main Components
- 20 Test cassettes
- 2 Sample extraction buffers
- 20 Sample tubes
- 20 Swabs
- 1 Tube Stand
- 1 Instruction For Use
Sample Collection
- By nasopharyngeal swab: The sampler gently holds the head of the person to be collected
with one hand, holds the swab with the other hand, sticks the swab
to the nostril to enter, and slowly penetrates backwards along the
bottom of the lower nasal passage, so as not to exert too much
force to avoid traumatic hemorrhage. When the tip of the swab
reaches the posterior wall of the nasopharynx cavity, gently rotate
it for one week (in case of reflex cough, stop for a minute), and
then slowly take out the swab.
- By oropharyngeal swab: The head of the person to be collected is slightly tilted and his
mouth is wide open, exposing the pharyngeal tonsils on both sides.
Wipe the swab across the root of the tongue. Wipe the pharyngeal
tonsils on both sides of the person to be collected back and forth
with a little force for at least 3 times, and then wipe up and down
the posterior pharyngeal wall for at least 3 times.
Use Step
- Take out the test cassette from the sealed pouch, place it on a
clean and level surface with the sample port well up.
Apply 2 full drops of the treated sample (60μl-70μl) vertically
into each of the two sample wells of the test cassette.
Observe the test results immediately within 15~20 minutes, the
result is invalid over 20 minutes.
Interpretation Of Result
POSITIVE: The presence of T (T on nCoV /A or B on Flu) and C lines within
the reaction window indicate a positive result on SARS-CoV-2 or Flu
A and/or B infection or co-infection.
NEGATIVE: One colored line appears in the control region(C). No apparent
colored line appears in the test region (T on nCoV /A or B on Flu).
The negative result does not indicate the absence of analytes in
the sample, it only indicates the level of tested analytes in the
sample is less than the minimum detection limit
INVALID: No colored lines appear, or control line fails to appear,
indicating that the operator error or reagent failure. Verify the
test procedure and repeat the test with a new testing device.
Feature
- Fast results as soon as 15 minutes
- Facilitates patient treatment decisions quickly
- Simple, time-saving procedure
- Little specimens, only few Nasal or throat swabs
- All necessary reagents provided & no equipment needed
- High sensitivity and specificity
FAQ
We have the limit order which is 10000, we would like to cooperate
with you, don't worry about MOQ, just send us of your what items
you want order.
Stock 3-7 days in general. Or please contact us by email for
specific lead time base on your order quantities.
Yes, we accept both OEM and ODM for customers.
- What are your terms of delivery?
We can accept EXW, FOB, CIF, etc. You can choose one which is the
most convenient for you.
- Manufacturer or Trade Company?
We're Manufacturer.
Company Profile
Labnovation Technologies, Inc. is an original manufacturer
established in Shenzhen, China since 2001. We are dedicated in
developing and manufacturing IVD instruments and reagents including
HbA1c analyzer and reagents, rapid test reader & reagents,
hematology reagents, clinical chemistry reagents, electrolyte
reagents, wash solution and urine test reagents.
Labnovation products are developed in house, tested extensively in
clinics and passed strict quality controls. All of our products are
CE marked and approved by SFDA. In the past 15 years, our products
have been exported to 110 different countries and used in 8000
hospitals worldwide. We provide both ready-to-use final products
and bulk OEM reagents, including ready-to-use reagents,
concentrated, and powder.
With an investment of 10% of our annual sales into R&D, we
release new products every years. We win more and more domestic and international cooperation by
company reputation and products quality while we actively take part
in fairs like MEDICA,AACC, ARBA HEALTH and so on through which we
are well-known by the companies in this field.