[XG001]COVID-19 Saliva Ag Test-HUBEI MEIBAO BIOTECHNOLOGYCO., LTD

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[XG001]COVID-19 Saliva Ag Test

Name: [XG001]COVID-19 Saliva Ag Test
Brand: MeiBao
SKU: [XG001]
Availability: InStock
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COVID-19 Saliva Ag Test is used for qualitative detection of the antigen of COVID-19 in human saliva sample

$0.00 USD

PRODUCT DETAIL

SPECIMEN PREPARATION

Note：

1. Under normal temperature, samples should be processed within 1 hour after collection. If the sample cannot be tested in time after treatment, the processed sample should be refrigerated at 2-8 ℃ and the test should be completed within 12 hours after treatment.

2. Freezing and thawing of samples is strictly prohibited.

TEST PROCEDURE

STORAGE AND STABILITY

Storage: store at 2~30℃. Shelf life: 24 months.

PERFORMANCE CHARACTERISTICS

1. Analytical Sensitivity

The Coretests® COVID-19 Saliva Ag Test LOD was confirmed as 22.5 TCID50/mL.

2. Analytic Specificity

Results demonstrated that Coretests® COVID-19 Saliva Ag Test has no significant cross-reactivity with the seromarkers listed following：

Potential Cross-Reactant		Test Concentration
Virus	Adenovirus	1.0 x 10⁵ TCID50/ml
	Human metapneumovirus (hMPV)	1.0 x 10⁵ TCID50/ml
	Rhinovirus	1.0 x 10⁵ PFU/ml
	Enterovirus/Coxsackievirus B4	1.0 x 10⁵ TCID50/ml
	Human coronavirus OC43	1.0 x 10⁵ TCID50/ml
	Human coronavirus 229E	1.0 x 10⁵ TCID50/ml
	Human coronavirus NL63	1.0 x 10⁵ TCID50/ml
	Human parainfluenza virus 1	1.0 x 10⁵ TCID50/ml
	Human parainfluenza virus 2	1.0 x 10⁵ TCID50/ml
	Human parainfluenza virus 3	1.0 x 10⁵ TCID50/ml
	Human parainfluenza virus 4	1.0 x 10⁵ TCID50/ml
	Influenza A	1.0 x 10⁵ TCID50/ml
	Influenza B	1.0 x 10⁵ TCID50/ml
	Respiratory Syncytial Virus A	1.0 x 10⁵ PFU/ml
Bacteria	Bordetella pertussis	1.0 x 10⁶ cells/ml
	Chlamydia pneumoniae	1.0 x 10⁶ IFU/ml
	Haemophilus influenzae	1.0 x 10⁶ cells/ml
	Legionella pnuemophila	1.0 x 10⁶ cells/ml
	Mycoplasma pneumoniae	1.0 x 10⁶ U/ml
	Streptococcus pneumoniae	1.0 x 10⁶ cells/ml
	Streptococcus pyogenes (group A)	1.0 x 10⁶ cells/ml
	Mycobacterium tuberculosis	1.0 x 10⁶ cells/ml
	Staphylococcus aureus	1.0 x 10⁶ org/ml
	Staphylococcus epidermidis	1.0 x 10⁶ org/ml
	Pooled human nasal wash	N/A
Yeast	Candida albicans	1.0 x 10⁶ cells/ml

1. Interference

The following substances and conditions were found not to interfere with the test. List of potentially interfering compounds and concentrations tested are as follows:

Substance	Active Ingredient	Concentration
Endogenous	Mucin	2% w/v
Endogenous	Whole Blood	1% v/v
Throat Lozenge	Benzocaine, Menthol	0.15% w/v
Sore Throat Phenol Spray	Phenol	15% v/v
Anti-viral Drug	Tamiflu (Oseltamivir Phosphate)	0.5% w/v
Antibacterial, Systemic	Tobramycin	0.0004% w/v

A clinical study using a total 712 saliva samples was conducted. The results of the COVID-19 Saliva Ag Test were compared with a nucleic acid detection test . The diagnostic sensitivity and specificity of the test results are given as below:

Table 1 - Comparison of COVID-19 Saliva Ag Test Device

Reference		Results of Nucleic acid detection test		Total Results
Reference		Positive	Negative	Total Results
Results of Coretests test	Positive	161	5	166
Results of Coretests test	Negative	4	542	546
Total Results		165	547	712

Results gave Sensitivity is 97.6% (161/165), specificity is 99.1% (542/547), and a total agreement of 98.7% (703/712).