Malaria Pf/Pan Ag Rapid Test

For the qualitative detection of Malaria Pf/Pan antigen in whole blood

Malaria Pf/Pan Antigen Rapid Test Kit Home Use Accurate Malaria Infectious Disease

Intended Use

The Malaria Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) antigen and P. vivax, P. ovale, or P. Malariea antigen in whole blood.

This device is intended to be used as a screening test and as an aid in the diagnosis of infection with Plasmodium. Any reactive specimen with the Malaria Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

Summary and Explanation of the Test

Malaria is a mosquito-borne, hemolytic, febrile illness that infects over 200 million people and kills more than 1 million people per year. It is caused by four species of Plasmodium: P. falciparum, P. vivax, P.ovale, and P. malariae. These plasmodia all infect and destroy human erythrocytes, producing chills, fever, anemia, and splenomegaly.

The Malaria Rapid Test is developed for solving these above obstacles. It detects the antibodies generated in serum or plasma in

response to the infection of plasmodium. Utilizing the Pf. specific antigen (HRP-II) and pan-malaria antigen (aldolase), the test enables simultaneous detection and differentiation of the infection of P.falciparum and or P. vivax, ovale, and malariae3-5, by untrained or minimally skilled personnel, without laboratory equipment.

Storage

Store the test kits at room temperature 4- 30℃degrees. The sealed pouch has a shelf life of 24 months.

Warning and Precautions

1. For in-vitro diagnostic use only

2. All patient samples should be treated as if capable of transmitting disease.

3. Do not interchange reagents from different lots. Do not use it beyond expiration date.

Reagents and Materials Provided

1. One pouch sealed with desiccant

2. Blood diluent buffer in a dropper bottle

3. One package insert

Materials Required But Not Provided

1. Clock or Timer

2. Lancing device for whole blood test

Sample Collection and Preparation

Whole Blood

Drops of whole blood can be obtained by either finger tip puncture or veinpuncture. Do not use any hemolyzed blood for testing.

Whole blood specimens should be stored in refrigeration (2°Ċ-8 °Ċ) if not tested immediately. The specimens must be tested within 24 hours of collection.

Test specimens as soon as possible after collecting. Store specimens at 2 to 8℃ if not tested immediately.

Store specimens at 2 to 8℃ up to 5 days. The specimens should be frozen at -20℃ for longer storage.

Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing.

Interpretation of Result

Negative: If only the C band is present, the absence of any burgundy color in the both T bands (T1 and T2) indicates that no plasmodium antigens are detected. The result is negative.

Positive: Pf positive: In addition to the presence of C band, if only T2 band is developed, the test indicates for the presence of pHRP-II antigen. The result is Pf positive.

Pan positive: In addition to the presence of C band, if only T1 band is developed, the test indicates for the presence of pLDH antigen. The result is either Pv, Pm, or Po positive.

Mixed positive: In addition to the presence of C band, both T1 and T2 bands are developed, the test indicates for the presence of both pHRP-II and pLDH. The result is positive.

Note: Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a positive determination is made.

Invalid: If no C band is developed, the assay is invalid regardless of any burgundy color in the T bands as indicated below. Repeat the assay with a new device.

Limitation

1.The Assay Procedure and the Test Result Interpretation must be followed closely when testing the presence of plasmodium protozoa

antigen in whole blood from individual subjects. Failure to follow the procedure may give inaccurate results.

2. The Malaria Rapid Test is limited to the qualitative detection of plasmodium protozoa antigen in whole blood. The intensity of the

test band does not have linear correlation with the antigen titer inthe specimen.

3. In the case of co-infection with Pf and any of the other three plasmodia, both T1 and T2 band will be developed. Thus, interpret

the result cautiously when both T1 and T2 bands are visible.

Newscen Biopharm Co., Limited is a professional manufacturer of in vitro diagnostic products and related supporting apparatuses, which is jointly founded by Tianjin Pharmaceutical Group, Tianjin Zhongxin Pharmaceuticals Co., Ltd and oversea Chinese entrepreneurs.

Founded in 2003, the company is one national high tech corporation and Tianjin Grade A medical device manufacturer. Over the years, the company has been committed to the research, development, production and sales of in vitro diagnostic products and related supporting apparatuses, and also has provided OEM and ODM and technology transfer and cooperation as well as some other customer market based diversified services to customers at home and abroad.

NewScen is based on independent innovation and relies on the talent sharing at home and abroad, information interaction advantage, antibody preparation and new product R & D technology platform to develop and produce nine series about one hundred kinds of products including tests and instruments and put on the market in succession.

HIV (1 + 2) antibody rapid test Kit and other IVD (In Vitro Diagnostic) devices obtained National Patent and National Class of New Drug Certificate; HCV Antibody Rapid Test is the first double antigen sandwich test HCV patented product; NewScen’s quantitative test broke through the technical difficulty of the colloid gold quantitative detection, opening up a new situation for clinical application of Colloidal Gold test. Rapid immuno assay reader provides an open and common platform for qualitative and quantitative detection of the Colloidal Gold test.

The company has received CFDA medical device certificates of 32 products, 49 independent Intellectual Property Rights, FDA certificates of series of products and European CE certificates of 16 products. Production management is in strict accordance with the regulations of in vitro diagnostic product production as well as international quality management system (ISO 9001, ISO 13485) so as to ensure high product quality. Products are sold throughout the country and in North America, South America, Southeast Asia, Europe, the Middle East, Africa and other international markets.

Currently, the company integrated Colloidal Gold test, immunochromatographic interpretoscope and cloud technology and other technical advantages, and created management integrated POCT system, so as to achieve convenient, accurate and efficient onsite data collection and remote guidance or data sharing of the monitoring center and promote the development of modern testing technique and the improvement of diagnosis and treatment level.

NewScen has obtained the project support from Tianjin or the country for nine times in succession, has been identified as one Hightech Enterprise in Tianjin, has obtained the title of “Top 100 Enterprise in Tianjin” among Tianjin SMEs, and is the rapid diagnostic Hightech demonstration project base and National 863 Project undertaker awarded by the NDRC (National Development and Reform Commission).

Fecal Occult Blood, Serum Ferritin and Hepatitis C rapid test products were named Tianjin independent innovation products; brand “YBT”products have been awarded the title of “Chinese Women and Children Favorite Brand Product” by Chinese Women and Children Development Center; “YBT” trademark was named “Tianjin Famous Trademark”.

“Honesty, Verity, Authenticity, and Innovation", is our persistent commitment.

“Encouraging Our Employees Growing With Company” is the driving force beneath our surging growth.