Strep A Antigen Rapid Test Kit

[Intended Use]

Strep A Antigen Rapid Test Kit is used for the in vitro qualitative detection of Group A Streptococcal antigens in human pharyngeal swab samples.

[Test Principle]

The kit is immunochromatographic and uses double-antibody sandwich method to detect Group A Streptococcus antigen.

[Components & Specification]

Components	Loading Quantity(Specification)
	1 Test/Kit	20 Tests/Kit
Test Card	1pc	20pcs
Sample extraction tube	1pc	20pcs
Sample A Diluent	1pc	20pcs
Sample B Diluent	1pc	20pcs
Swab	1pc	20pcs
Waste Bag	1pc	20pcs

[Storage & Shelf Life]

1). Stored at 2~30℃.

2). Valid for 24 months(Fresh production date when shipping).

[Performance]

1). Sensitivity 93.20%

2). Specificity 100%

3). Total conincidence rate 96.53%

[Applicable Scenario]

Medical labs, Clinic, Basic medical institutions, At home self-testing, etc.

[Testing Process]

[Results Interpretation]

[Positive]

A positive test result indicates that antigens from Group A streptococcus were detected, and the patient is very likely to be infected with the virus and presumed to be contagious.

Note: A positive result means that you are likely to be infected with Group A streptococcus.

Note: Test results should always be interpreted in the context of clinical observations and epidemiological data when making final diagnoses and patient management decisions.

[Negative]

A negative test result indicates that antigens from Group A streptococcus were not detected from the specimen. However,a negative result does not rule out Group A streptococcus and should not be used as the sole basis for treatment or patient management decisions, induding infection control decisions. Negative results should be considered in the context of an individul's recent exposures, history, and the presence of clinical signs and symptoms consistent with Group A streptococcus and confirmed with a molecular assay, if necessary, for patient management.

[Invalid]

If any of the control(C) lines do not appear, the test must be interpreted as invalid. An invalid test result means that your test has encountered an error and the results cannot be interpreted. You will need to retest using a new test card.

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