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Infectious Disease State

ACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab)

01-ABT-IDT-B367

Accu-Tell® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab) is a Rapid Diagnostic Test (RDT) tool with the principle of rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen associated with SARS-CoV-2 Nucleocapsid (N) protein in patient samples in the form of nasopharyngeal swabs. PT Isotekindo Intertama is the official distributor for Accu-Tell® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab) and registered with the Ministry of Health Republic of Indonesia.

Variant

ACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab)

Selling Packaging

Box (folding box)

Box Packaging Material

Cardboard

Box Dimensions

200 x 120 x 80 (mm)

Test Cassette Packaging Material

Aluminum Foil

Quantity 1 Box

20 pcs

Contents/box

Test cassette; Extraction tube and droppers tips; Nasopharyngeal swab; 1 bottle buffer; Insert Pack; Extraction tube holder

Buffer Volume

10 ml

Break Point Length Swab

8,5 cm

Sample Used

Mucous fluid from nasopharyngeal swab

Principle

Rapid chromatographic immunoassay

Reading Time

10 minutes

Recommended Storage Temperature

2-30°C

Expired Date

2 years from manufacturing date

FEATURE	BENEFIT
1 box contains: Test cassette Extraction tube and cap Nasopharyngeal swab Buffer	Does not require additional tools and materials when using the product (except personal protective equipment and waste collection)
1 bottle of the buffer is available for 20 tests (Additional buffer solution bottles are available if needed)	Practically used by 1 user in the laboratory
Samples were taken from nasopharyngeal swabs	Practical and comfortable for patients because it is not invasive (not injuring)
The position of the break point of the flocked swab is far from the head of the swab (8-8,5 cm)	Avoiding contamination for users and providing safety if the flocked swab sticks break during sampling & easy to retrieve
The principle used is rapid chromatographic immunoassay	Makes it easy for users to read the results through the color lines that are formed in a short time
Results can be interpreted at 10 minutes	Users can define the next immediate action referring to the results that appear
The product has been tested at the Ministry of Health Republic of Indonesia Reference Laboratory, BBLK RI Jakarta. For CT positive samples ≤ 25: sensitivity 100%, specificity 100%, accuracy 100%	Able to detect the presence of the SARS-CoV-2 virus properly during the initial phase of infection where there is a high viral load Has fulfil the RDT selection criteria according to the Decree of the Minister of Health Republic of Indonesia No. HK.01.07/MENKES/3602/2021
The product has been tested at the Ministry of Health Republic of Indonesia Reference Laboratory, Balitbangkes. For CT positive samples ≤ 25: sensitivity 100%, specificity 97%, accuracy 98%	Able to detect the presence of the SARS-CoV-2 virus properly during the initial phase of infection where there is a high viral load Has fulfil the RDT selection criteria according to the Decree of the Minister of Health Republic of Indonesia No. HK.01.07/MENKES/3602/2021
Products have CE certification and has an AKL permit from Ministry of Health Republic of Indonesia	Guaranteed quality according to domestic and global recommendations
Expiration 2 years from the date of production	Users can keep a certain amount of stock without worrying about the product quality being reduced