Antigen Test Kit (colloidal gold method) 

Antigen Test Kit (colloidal gold method)

PACKAGE SPECIFICATION

This kit is only used for the in vitro qualitative detection of antigen from human nasopharyngeal swabs or oropharyngeal swabs specimens. 
This kit is suitable for the auxiliary diagnosis, the results are for clinical reference only and cannot be used as the sole basis for diagnosis and exclusion decision. The clinical diagnosis and treatment of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests and treatment responses.
Positive test result needs to be further confirmed, negative result does not preclude the infection.
This kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures. 

The kit is immunochromatographic and uses double-antibody sandwich method to detect antigen. During detection, the treated specimens are loaded into the sample wells of the test card. When the concentration of  antigen in specimen is higher than the minimum detection limit, the viral antigen will form complexes with labeled antibodies first. Under chromatography, the complexes move forward along the nitrocellulose membrane till captured by pre-coated monoclonal antibody of n detection zone on nitrocellulose film (T) to form a pink/purple reaction line on the detection zone, at this point the result is positive; conversely, if there is no viral antigen or the concentration of antigen in specimen is below the minimum detection limit, no pink/purple reaction line appears in the detection zone, at this point the result is negative. Regardless of whether the sample contains viral antigens or not, a pink/purple reaction line will appear in the quality control zone (C), the pink/purple reaction line that appears in the quality control zone (C) is the criterion for determining if the chromatography process is normal.

The test kit consists of test card, sample diluent, sample extraction tube, droppers lid, sterile sampling swab.

1. Test cards are sealed together desiccant in aluminum foil pouch.
2. Do not mix use different batches of test cards and sample diluent.

The test card and sample diluent should be stored at 2ºC~30ºC, valid for 18 months. Test cards should be used as soon as possible within 1 hour after opening the foil pouch. The bottle of sample diluent should be capped immediately after use and stored at 2ºC~30ºC, please use it within the validity period.

	1. Nasopharyngeal swab collection: Ask the patient to keep the head still to remove surface secretions from the anterior nasal foramen; Gently and slowly insert the swab through the nasal cavity to the nasopharynx, it reaches the posterior nasopharynx when resistance is encountered. Remain for several seconds to aspirate secretions; remove the swab with gentle rotation.
	2. Oropharyngeal swab collection: Insert the swab in the mouth completely into the pharynx, centering on the red swelling of the pharynx wall and upper anterior tonsils. Wipe both sides of pharyngeal tonsils and pharynx posterior wall with moderate force, avoid touching the tongue, and remove the swab.

Please read the instruction manual seriously before testing. If the reagents in kit are stored in refrigerator, please take them out and leave them at room temperature before testing. The test should be done at room temperature.

3. Please read the chromogenic results in the detection zone between 15~20 minutes to ensure proper test performance. Do not read results after 30 minutes. Results read after 30 minutes are invalid.

INTERPRETATION OF TEST RESULTS
Figure 2

1. The test results of this kit are only for the reference of clinicians and should not be used as the sole basis for clinical diagnosis and treatment. Clinical management of patients should be considered in the context of their symptoms/signs, medical history, other laboratory tests and response to treatment.

1. The width of the membrane strip of this kit is not less than 2.5 mm, and the liquid migration speed is not less than 10 mm/min.

 

 

6.2 Hecin Antigen Test Kit (colloidal gold method) Performance against PCR Comparator Method on oropharyngeal swabs specimens.

Hecin  Antigen Test Kit (colloidal gold method)	PCR Comparator Method		Total
	Positive	Negative
Positive	30	1	31
Negative	3	107	110
Total	33	108	141
Relative sensitivity	30/33         90.91% (95%CI: 75.67%~98.08%)
Relative specificity	107/108     99.07% (95%CI: 94.95%~99.98%)
Accuracy	137/141     97.16% (95%CI: 92.90%~99.22%)

PRECAUTIONS

1. This is a single-use in vitro diagnostic reagent, do not reuse, and do not use expired products. 
2. Relative studies on showed that the detection rate of the nasopharyngeal swab specimen was slightly higher than that of the oropharyngeal swab specimen, therefore it is recommended to use nasopharyngeal swab specimens for testing.
3. All test specimens must be considered potentially infectious, and during collection, processing, storage, mixing of specimens and testing should be taken appropriate protective measures. Therefore, wear protective measures such as wearing gloves and masks should be done, and dispose of all wastes as potentially biohazardous items. (Used cotton swabs, test cards, extraction tubes, etc., should be decontaminated before disposal and tested for autoclaving.)
4. Use the swab and sample diluent provided with this reagent for sampling, and do not mix use different batches of test cards and sample diluent. 
5. Use fresh specimens for testing, do not use repeated freeze-thaw samples. 
6. Operate at room temperature. Test cards kept at low temperature should be restored to room temperature before opening to avoid moisture absorption.
7. Do not use reagent kits with obvious damage or test cards with damaged or expired packaging. 
8. The aluminum foil pouch contains desiccant and must not be taken orally.
9. Improper sample collection or processing may result in false-negative results. 
10. If the initial screen is a positive sample, contact your local public health agency.
11. As with the diagnostic reagents used, the final diagnosis should be made by a physician after combining the various test parameters and clinical symptoms. 
12. If you have any questions or suggestions on the use of this kit, please contact the manufacturer.

SYMBOLS

Contact information:
 

Guangdong Hecin Scientific, Inc.
4F, Building 1, #1 Ruifa Rd, Luogang District,Guangzhou City, Guangdong Province, 510530, P. R. China 
susan huang 
18602044084

SUNGO Europe B.V.
Olympisch Stadion 24,1076 DE Amsterdam ,Netherlands