LATERAL FLOW TESTS-IDEAL CHOICE FOR LABS-RAPID SOLUTIONS From BBC Pharmaceutical Services Ltd

1. LATERAL FLOW TESTS-IDEAL CHOICE FOR LABS-RAPID SOLUTIONS From BBC Pharmaceutical Services Ltd * Parminder Kalsi * University POLITEHNICA of Bucharest * BBC Pharmaceutical Services Ltd

2. INTRODUCTION • Clinical and environmental analyses frequently necessitate rapid, simple and inexpensiv tests. • The lateral flow tests (rapid tests) are qualitative and provide an assay format suiting these application extremely well. • A good place to start is to examine the raw materials that will deliver the highest quality at the lowest cost.

3. LATERAL FLOW ASSAY ARHITECTURE

4. THE SAMPLE PAD • Is made of cellulose, glass fiber or other material where the fluid sample (urine, serum, plasma, whole blood) is applied to the lateral flow device and, if necessary modifies it to improve the results of the assay. This might be by modifying pH, filtering out solid components, separating whol blood constituents, adsorbing out unwanted antibodies or some other test specific variable.

5. THE CONJUGATE PAD • Is made of a non-absorbent material such as fiberglass pad, polyester or a similar material. • When the sample is applied to the sample pad, the liquid from the sample, by capillary action moves into the conjugate pad, rehydrates the dry gold conjugate and allows the mixing of the sample with the conjugate. The complex of gold conjugate and analyte then moves into and up the membrane.

6. DETECTION CONJUGATE • The tests may use colloidal metals (gold or silver), carbon, visible or florescent dye etc which are conjugated to either an antibody or antigen to generate signal. In most commonly used signal reagent is colloidal gold today. • Conjugate is added to the pad in one of two methods, immersion or spraying.

7. DETECTION CONJUGATE • In immersion the conjugate pad is submerged in the conjugate-protein suspension. • In spraying the pad is coated using quantitative, directional aerosol dispenser. Spraying offers much more control of the conjugate application and prevents dilution and washing away of the pad pretreatment, but it also adds a significant capital expense and might increase the complexity of strip manufacturing. CAMP MEDICA use a BIO DOT dispencer for spraying the pad with colloidal gold.

8. NITRO-CELLULOSE (NC)MEMBRANE • Some options for membrane are: nitrocellulose (high protein binding), cellulose acetate (low protein binding) and glass fiber membranes (non-protein binding). Membrane manufacturers generally offer a wide variety of material types and pore sizes. • The benefits of NC include low cost, capillary flow, high binding affinity for protein, ease of handling and cutting.

9. TEST AND CONTROL REAGENT LINES • The complex of gold conjugate and analyte then moves onto the membrane strip and migrates towards the capture binding protein, where it becomes immobilized and produces a district signal in the form of a sharp red line. • A second line, a control, may also be formed on the membrane by excess gold conjugate, indicating the test is complete.

10. ABSORBENT PAD (WICKING PAD) • This pad pulls fluid off of the membrane to allow the capillary flow of the membrane to keep flowing in the proper direction and at the proper rate. • If an absorbent pad isn’t used, the sample and buffer will back flow down the membrane and could raise the background or possibly cause false positives. This can also occur if the absorbent pad selected for the volumes of buffer and sample involved is inadequate.

11. SUMMARY OF MANUFACTURING PROCESSES

12. ASSEMBLY

13. BBC Pharmaceutical Services Distributor for Camp Medica • CAMP MEDICA is first producer from Romania which developed “See Now” rapid tests on the market. It can be applied for multiple test platforms for liver, sexually transmitted diseases, drugs of abuse, cardiac markers, as well as women’s and men’s health (hCG, LH, FSH, AFP, CEA, PSA, Syphillis, Gonorrhea, H.Pylori, Troponin I, Myoglobin, CK-MB, HIV, HBsAg, HCV, all drugs like AMP, BZO, COC, Ecstasy, OPI, THC…)

14. COMPARABLE RESULTS H.Pylori samples tested • LEGEND: • Positive • Weak positive • Negative

15. COMPARABLE RESULTS Syphilis samples tested • LEGEND: • Positive • Weak positive • Negative

16. SUMMARY • Main factors for market growth are: • Increasing decentralization of medicine, where testing is moving away from hospitals and doctors offices to off-site testing facilities, pharmacies, as well as into the individual’s home; • Benefits in the diagnostic process because of reduced time spent awaiting test results;

17. SUMMARY • The ease of use allows at-home testing and request less training for technicians; • The results are comparable with another expensive technology (HPLC, ELISA, LATEX etc); • The tests protect damage and environment contamination.

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