Clean area management training for the production of rapid test kits for dengue fever and malaria

2024-06-14 16:23:25 Zhejiang QL Biotech Co.,Ltd Number of views 1422

 

 

There have been a large number of dengue fever and malaria outbreaks recently. For the subsequent production of dengue fever rapid detection reagents and malaria rapid detection reagents, our company has organized clean area management training in the production workshop, and arranged and deployed the next stage of work tasks in a targeted manner. Colleagues from the Quality Department delivered a speech.

The training content is mainly divided into 5 sections:

Introduction to clean area

Process of personnel entering and exiting clean area

Process of materials entering and exiting clean area

Sanitary management of clean area

Environmental monitoring of clean area

Clean room introduction

A room (area) where the dust and microbial content needs to be controlled. Its building structure, equipment and functions all have the function of reducing the entry of pollution sources in the room (area) and the generation of combined retention. The production of rapid test reagents for dengue fever and malaria requires quite strict production conditions. Therefore, workshop personnel need to abide by the regulations when entering the clean room and must not violate them, otherwise it is easy to cause product contamination.

Procedures for personnel entering and exiting the clean area

Cleanroom workers are not allowed to wear makeup, jewelry, or long nails.

Develop good hygiene habits and keep personal hygiene.

Smoking, eating, and bringing in daily necessities, food, and personal items are not allowed in the production operation area.

Temporary entry into the cleanroom requires training or accompaniment by designated personnel, and the "Registration Form for Outsiders Entering and Leaving the Cleanroom" needs to be filled out.

Because of that our products have very good quality.

As you can see our Clinical Performance

Dengue IgG/IgM Rapid Test:

The specimens obtained from a population of symptomatic and asymptomatic individuals. Results were confirmed by a leading commercial Dengue ELISA test.

Dengue IgG/IgM Rapid Test vs. ELISA

Dengue Infection

Result

Ig M

IgG

Primary Infection

Positive

14

0

Negative

3

17

Total

17

17

Relative Sensitivity

82.4%

0%

Secondary Infection

Positive

39

55

Negative

16

0

Total

55

55

Relative Sensitivity

70.9%

>99.0%

Non-Dengue Infection

Positive

0

0

Negative

378

378

Total

378

378

Relative Specificity

>99.0%

>99.0%


For the primary and secondary infection, the overall sensitivity is 95.8%, the overall specificity is >99.0% and the overall accuracy is 99.3%.

 

Dengue NS1 Rapid Test:

A total of 114 patient samples from susceptible subjects were tested by the Dengue NS1 Rapid Test Strip and by a commercial EIA. Comparison for all subjects is showed in the following table:

 

 Dengue NS1 Rapid Test  

 

Dengue Ag EIA Test

Positive

Negative

Total

Positive

66

3

69

Negative

2

43

45

Total

68

46

114

Relative Sensitivity: 95.6%, Relative Specificity: 95.5%, Overall Agreement:  95.6%

The Malaria P.f./ P.v. Rapid Test Device

Sensitivity

The Malaria P.f./ P.v. Rapid Test Device (Whole Blood) has been tested with microscopy on clinical samples. The results show that the sensitivity of the Malaria P.f./ P.v. Rapid Test Device (Whole Blood) is >98% when compared to results obtained with microscopy.

Specificity

The Malaria P.f./ P.v. Rapid Test Device (Whole Blood) uses antibodies that are highly specific to Malaria P.f.-specific and P.vivaxLDH antigens in whole blood. The results show that the specificity of the Malaria P.f./ P.v. Rapid Test Device (Whole Blood) is over 99.9%, when compared to results obtained with microscopy.

Method

Microscopy

Total Results

Malaria P.f./ P.v.

Rapid Test Device

Results

Positive

Negative

P. v.

P. f.

Positive

49

80

0

129

Negative

1

0

451

452

Total Results

50

80

451

581

Comment: Blood Samples infected by Plasmodium falciparum (n=80).Plasmodium vivax (n=50) were included, as well as 451 malaria negative samples to be confirmed with microscopy.

Relative Sensitivity for P.f.-specific antigens: 80/80> 99.9% (96.4%~100.0%)*

Relative Sensitivity for P.v. antigens: 49/50=98.0% (89.6%~100.0%)*

Relative Specificity: 451/451>99.9% (99.3%~100.0%)*

Accuracy: (49+80+451)/(50+80+451)=580/581=99.8% (99.0%~100.0%)*

* 95% Confidence Interval

 

 

 

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