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Informazioni di Base.
Descrizione del Prodotto
Malaria antigen detection kit is designed as a simple, rapid, qualitative and cost effective method for the simultaneous detection and differentiation of Plasmodium falciparum (P.f) and Plasmodium vivax (P.v) in human whole blood or fingertip whole blood. This device is intended to be used as a screening test and used for the auxiliary diagnosis of P. f and P.v infection.
The Malaria antigen test kit (Lateral chromatography) is based on the principle of microsphere double antibody sandwich method to rapid qualitative determination of P.f/ P.v antigen in human whole blood or fingertip whole blood. The microsphere is marked in anti-HRP-2 antibody (specific to P.f) on the T1 band and anti-PLDH antibody(specific to P.v) on the T2 band, and anti-mouse IgG polyclonal antibody is coated on quality control area (C). When the sample contains malaria HRP2 or pLDH antigen and the concentration is higher than the minimum detection limit, which are allowed to react with the colloidal microsphere coated with Mal-antibody to form antibody-antigen complex. The complex then moves laterally on the membrane and respectively binds to the antibody immobilized on the membrane producing a pink line on the test region, which indicates a positive result. The presence of the control line demonstrates the test has been performed correctly regardless the presence of P.f/ P.v antigen.
The presence of two colored bands ("T1" and "C") within the result window indicates P.f Positive.
2.P.v Positive
The presence of two colored bands ("T2"and "C") within the result window indicates P.v.
3.Positive. P.f and P.v Positive
The presence of three colored bands ("T1","T2"and "C") within the result window may indicates mixed infection of P. f and Pan.
4.Negative Result
The presence of only control line(C) within the result window indicates a negative result.
5.Invalid Result
If no band appears in the control region(C), the test results are invalid regardless of the presence or absence of line in the test region(T). The direction may not have been followed correctly or the test may have deteriorated It is recommended that repeat the test using a new device.
NOTE:
The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.
| Uncut Sheet of Rapid test Kit-Colloidal gold | |||
| Chlamydia | C. pneumoniae | H. Pylori | Malaria |
| Rotavirus | Adenovirus | Rota/Adeno | Strep A |
| Syphilis | HBsAg | HBsAb | HBsAg and HCV |
| HBsAg /HCV /HIV /Syphilis | Dengue IgG/IgM | Dengue Ns1 | Dengue IgG/IgM /NS1 |
| Chikungunya | Cholera | Typhoid | Tuberculosis |
| HIV1+2 | HIV1+2 Ag/Ab | HAV | ToRCH |
| HCV | HSV | RSV | TOXO |
| Rubella | CMV | Norovirus | Leishmania |
| Filariasis | Leptospira | Monkeypox | M.Pneumoniae |
| Chagas | Brucella | HPV | nCoV |
| Influenza A+B | Influenza A+B/ nCoV | Influenza A+B/nCoV/RSV | FOB |
| HCG | LH | IGFBP-1 | fFN |
| AMH | AMH/FSH | MxA | cTnI |
| 25-OH VD | The Customized cut -off and size are available | ||
| Uncut Sheet of Lateral Flow Quantitive Test Kit | |||
| Class | Rapid Test | Sample type | Detection Range |
| Cardiac Marker | cTn I | Serum/Plasma/Whole blood | 0.1~40 ng/mL |
| NT-proBNP | Serum/Plasma/Whole blood | 100~20000 pg/mL | |
| CK-MB | Serum/Plasma/Whole blood | 1ng/mL~100ng/mL | |
| BNP | Plasma/Whole blood | 5pg/mL~5000pg/mL | |
| cTnT | Serum/Plasma/Whole blood | 30pg/mL~25000pg/mL | |
| Myo | Serum/Plasma/Whole blood | 5ng/mL~500ng/mL | |
| cTnl/ Myo/ CK-MB | Serum/Plasma/Whole blood | cTnI: 0.1ng/mL~40ng/mL;Myo: 5ng/mL~500ng/mL;CK-MB: 1ng/mL~100ng/mL | |
| D-Dimer/ cTnI/ NT-proBNP | Serum/Plasma/Whole blood | Dimer: 0.1mg/L~10mg/L; cTnI: 0.1ng/mL~40ng/mL; NT-proBNP: 100pg/mL~20000pg/mL | |
| Inflammatory | PCT | Serum/Plasma/Whole blood | 0.1~100 pg/mL |
| CRP | Serum/Plasma/Whole blood | 0.5~200mg/L | |
| SAA | Serum/Plasma/Whole blood | 5~300mg/L | |
| IL-6 | Serum/Plasma/Whole blood | 5~5000 pg/mL | |
| PCT/ IL-6 | Serum/Plasma/Whole blood | PCT: 0.1ng/mL~100ng/mL;IL-6:10pg/mL~10000pg/mL | |
| CRP/ SAA | Serum/Plasma/Whole blood | CRP 0.5mg/L~200mg/L;SAA 5mg/L~300mg/L, | |
| Glycated hemoglobin | HbA1c | Whole blood | 3~14% |
| Tumor | PSA | Serum/Plasma/Whole blood | 2~80 ng/mL |
| HCG | HCG | Serum/Plasma/Whole blood | 5~200000mIU/mL |
| Anticoagulation | D-Dimer | Plasma/Whole blood | 0.1~10 mg/L |
| Endocrine | TSH | Serum/Plasma/Whole blood | 0.1mIU/L ~100.0mIU/L |
| T3 | Serum/Plasma/Whole blood | 0.61~9.22 nmol/L | |
| T4 | Serum/Plasma/Whole blood | 12.87~310 nmol/L | |
| FT3 | Serum/Plasma/Whole blood | 0.60pmol/L ~45.00pmol/L | |
| FT4 | Serum/Plasma/Whole blood | 1.00pmol/L ~100.00pmol/L | |
| AMH | Serum/Plasma/Whole blood | 0.1~16 ng/mL | |
| PROG | Serum/Plasma | 0.35ng/mL~60ng/mL | |
| PRL | Serum/Plasma/Whole blood | 1 ng/mL~200ng/mL | |
| FSH | Serum/Plasma/Whole blood | 1mIU/mL~100 mIU/mL | |
| LH | Serum/Plasma/Whole blood | 1 ~100 mIU/mL | |
| TES | Serum/Plasma | 0.2~15 ng/mL | |
| E2 | Serum/Plasma/Whole blood | 15 pg/mL~3000pg/mL | |
| Bone | 25-OH-VD | Serum/Plasma/Whole blood | 5.0ng/mL~100.0ng/mL |
| The Customized cut -off and size are available | |||
